Almost two years after Public Citizen first asked the Food and Drug Administration to increase its warnings about the risks associated with Cipro and other fluorquinolone antibiotics, the FDA has finally gotten around to doing something. While these antibiotics are very popular, an alarming number of people who have taken them have suffered tendon ruptures. I talked to a South Florida man on the phone the other day who had three tendon ruptures before he came across information on the internet that linked fluorquinolone antibiotics to his injuries. You have wonder if the FDA could have spared him some grief if it hadn’t taken so long to act.

The FDA announcement this morning says it will require a “black box” warning on the medicines and require a medication guide be given to patients when they get their prescriptions filled. That’s still not enough. In the petition we filed in August 2006, we also asked the FDA to require pharma companies to send letters to doctors warning them about the pretty awful side effects of these antibiotics.

Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said:

We are troubled that the FDA is not doing everything within its power to prevent more people from needlessly suffering disabling tendon ruptures. Nothing could be simpler and more effective than a letter to doctors in addition to what the FDA has proposed.

Public Citizen sued the FDA in January of this year because it had not responded one way or the other to our petition. That lawsuit will continue until the FDA addresses our petition in full, Wolfe said.

What really doesn’t make sense is why, if there’s enough reason to warrant black box warnings and medication guides for patients, the FDA doesn’t want to ask drug makers to send warning letters to doctors.

The AP’s Ricardo Alonso-Zaldivar has more in his story, “FDA calls for urgent warning on tendon risks.”

From Alonso-Zaldivar:

Some of the ruptures reported to the FDA occurred without warning — the patient felt a snap or pop soon after starting treatment. That suggests flouroquinolone antibiotics may be toxic to some people, the FDA said.

But typically, patients felt some kind of pain or inflammation for a week or two before they suffered a tendon rupture. That suggests that many of the most serious problems can be avoided if patients stop the drug, officials said.

The FDA’s analysis found that patients with the highest risk of problems include people over 60, those with kidney, heart and lung transplants, and those also taking steroids.

Manufacturers called the tendon ruptures a rare side effect. They said are complying with the FDA order and remain confident that the drugs’ benefits outweigh their risks.

Comments

  • Any idea how long people who got tendon troubles had been taking the meds?

  • Annie P

    I was put on Ran-Cefprozil 500mg 2 weeks ago and I have since developed Achilles Tendinitis in both feet. I finished taking the antibiotics and am now taking anti-inflamatory meds for the tendinitis. I will contact my Dr to inform her of your findings. Do you have any advice for me. Thanks.

  • Ugh. I was just on this stuff for a week. Nothing like this happened, though, and it sure made my kidney infection go away!

  • Marlee

    Avelox made me unable to walk for 3 months, have seizure activity, become confused at times and have a rapid heart rate. The only thing good about this family of drugs was, I went on to medical school. Floxins are very dangerous.

  • ciprovictimalso

    My husband was prescribed a 15 day supply of Cipro 500mg in 1998. He took it all as directed. Around a month later, he started having terrible pain in his joints & muscles. He thought he was developing some kind of rheumatoid arthritis. This pain was really bad. He started having insomnia & when he would finally fall asleep, vivid nightmares. His arms & legs started to jerk especially when he tried to rest. His depression became severe and there were suicidal thoughts & acts. The panic attacks he started having didn’t help. The left corner of his bottom lip swole up terribly looking deformed. He just woke up 1 morning like that & it went away a few days later. He developed little tiny sores around his ankles that looked like ant bites. He started having quite a bit of rectal bleeding. He started having numbness in his fingers and legs. He seemed to have a problem concentrating. Around 11 months after taking Cipro, he had his first rupture in his left back calf. I believe the doctor referred to it as being in the soleus group. It tore completely away from the bottom where it was attached. My husband was very ashamed of how his calf looked & stopped wearing shorts. If you’ve ever seen anyone who had polio that 1 calf looked distinctly smaller than the other, that’s what his looked like. It’s still torn loose in his leg. That left him with a limp, weakness in his leg & pain. That was in 1999. In 2000, another rupture occurred in his right knee. An operation was performed to repair this. In 2001, a quadriceps muscle tore in half midway up his right thigh. It’s still torn. There were numerous cases of tendonitis. Sometimes his left elbow, sometimes his right elbow & on a few occasions both elbows at the same time. There were no more ruptures for the next few years. In 2004, he was prescribed CiproXR 1000 once a day for 15 days. Around 11 months later, his right triceps ruptured at his elbow. That was in 2005. He had 3 ruptures total in 2005 that involved both his arms. The last rupture occurred in his lower left forearm while using the amount of pressure a person would use to squeeze a blood pressure bulb. Back spasms increased. He started having quite a few severe headaches & migraines. It appears that high blood pressure is the cause of this. Pain may be the cause of the high blood pressure. The bleeding got worse, the jerking movement of his arms & legs got worse, panic attacks got worse, suicidal thoughts & actions started again etc. Tests have confirmed he has neuropathies in his legs & hands. He drops everything and can’t feel his fingers. He can’t walk very far & uses a cane. I try to take him out to a store every now & then & push him in a wheelchair because he can’t be on his legs very long even with a cane. Sometimes he tries to hang onto a grocery cart for support because it embarrasses him being in a wheelchair. This causes him to have back spasms when using the grocery cart for support. Before all this, he was in great physical condition. He was such a hard working man. He was the true handyman who could do it all. He is a former Marine who once had more muscles than most young men and was very strong for his size. He once worked out with a world class weight lifter. Before Cipro, he could pick up a transmission by himself. He did that. I have taken him to see almost a dozen different doctors. I begged some of them to please find out what was happening to him. I kept telling them this was not normal for a man’s body to rip like that. None of them knew why this was happening. I had been searching the Internet for years looking for some disease that could be causing it. One day I ran across an article about Cipro & tendon ruptures. I cried when I realized what had happened to him. A once healthy man had 6 ruptures in his body. Not a single doctor ever made the connection between Cipro & the ruptures. How many others are having ruptures & no one knows why? A black box back then could have prevented all this.

  • Hip Knee Seattle

    Have you taken Levaquin and Cipro? The FDA recently warned consumers about a risk some say was a known risk for some time that taking the drugs can cause tendon ruptures in patients – a potentially serious and painful condition.

    I work with a law firm that’s investigating whether the drug makers did enough to warn patients of the risks.

    We have also heard from physical trainers and others that if patients simply knew of the risks, they might opt to reduce physical activities that might cause a rupture while taking these drugs.

    We want to hear from Levaquin and Cipro patients who’ve experienced similar symptoms. Check out our investigation at our firm’s Web site, http://www.hbsslaw.com for more information.

  • Teresa

    Thank you for this website. I had a terrible experience with Avelox after taking it for 8 days. Felt as if all the muscles in my hips and legs had been pulled, and also had electric shock sensations for several weeks. For at least 2 weeks, it was painful just to walk. I spoke to 2 others people who had been on Avelox, and both reported stopping before finishing the recommended dose due to joint problems. Please keep letting people know how harmful these drugs can be!

  • One thing to keep in mind is that Public Citizen is not asking the FDA to ban these antibiotics.

    We just want people to be aware that if they start feeling pain in their tendons that it could be related to their medication and they need to let their doctors know immediately.

  • deathbycipro

    Joe,
    The fact that Cipro and quinolones can cause permanent, untreatable tendon damage as highlighted by the need for a black box warning, that leaves patients with crippling untreatable pain, is only the tip of the iceberg when it comes to the other severe and permanently disabling adverse reactions that Cipro and other quinolones can inflict.
    The product information sheets provided by quinolone manufacturers fail to indicate that some individuals will suffer from multiple adverse reactions that will become permanent and untreatable. They list a wide variety of adverse reactions that would seriously impair anyone’s quality of life, psychological, neurological as well as physical, if one had to live with only a few of them for life. Some of these reactions can develop days, weeks or months after taking these pills as well, making if more difficult to identify the drugs as the culprit of the disease.

    I as well as numerous other individuals, who have tried to report these reactions to their physicians and the FDA, have been ‘ignored’ or ‘rebuffed’. I have a ‘constellation’ of symptoms from taking Cipro in 2006 that do not respond to treatment. My permanent adverse reactions include tinnitus, hyperacusis, visual distortions and light sensitivity, smell and taste perversion, insomnia, anhedonia, chronic fatigue, anxiety and severe depression, loss of appetite, peripheral neuropathy, hypertension, hyperlipidemia, hypothyroid, brain fog, memory problems, constipation and 25 pounds of weight loss in addition to the muscular and degenerative bone issues. Tendonitis is a small part of the entire picture. If you find this hard to believe, check the ADR lists for Cipro and Levaquin. They’re all listed, but are considered “rare” reactions. Only tendon damage and peripheral neuropathy are indicated as possible permanent adverse reactions. What I and many others dispute is how “rarely” they occur, and we report that many of these adverse reactions cannot be treated and remain permanent long after taking the drugs. And when people report that they do occur after taking Cipro, or Levaquin, doctors are reticent to admit they were caused by the drugs, especially if they develop in these ‘constellation’ of maladies.

    I feel sick every day, every minute of every day since July 2006. This is consistent with many of the reports of other individuals who took these quinolone drugs and experienced these ‘constellations’ of reactions that remain permanent till this day. My condition has deteriorated over these past years and continues to do so. No doctor has been able to treat any of my symptoms, let alone explain why they happened all at once.

    If Cipro can damage tendons, it certainly can damage other organs and muscles…which is why so many quinolone sufferers report a constellation of symptoms – because this class of drugs has the potential to cripple every system in the body, physiologically, neurologically and psychologically. There is a compilation of evidence at http://www.fqresearch.org, which should be reviewed by the FDA and medical profession. We hope that eventually the FDA will reexamine their data, that people will be taken seriously when they report these symptoms, that there will be stronger warnings as to the other permanent side effects of Cipro and related drugs, and that serious research efforts will begin to determine why this class of antibiotics are so damaging to some individuals, so others will not be injured.

    Perhaps public citizen can help us get the word out on the other devestating side effects of Cipro. Tendons are a great start. Let’s finish the job.

    Contact me at dbcipro ‘at’ yahoo.com

    Leave a comment on my weblog http://deathbycipro.wordpress.com

  • I only took 3 doses of cipro in total before realizing what was happening — but boy was it too late!!! By my third dose I went from being a very healthy 23 year old male who was athletic for over 10 years doing Karate, Yoga, Football, Judo and other sports, I eat an extremely healthy diet, and generally take care of myself… to not being able to function at all. I noticed the side effects about two hours after taking cipro.

    After my very first dose of cipro I had a cascade of symptoms that I never experienced in my life before such as; Bilateral Achilles Tendinitis, Tendinitis in both wrists, Chronic insomnia where I’d keep waking up every 1 hour (NEVER HAD INSOMNIA IN MY LIFE BEFORE!, Nightmares, peripheral neuropathy (burning, tingling, numbness), constant body tremors, dry eyes, dry mouth, dry skin, pulsating sensation in my stomach/neck/hands, pulsatile tinnitus, tinnitus, muscle pains, joint pains. Eye flashes, eye floaters, static vision, inability to adjust from light to dark (right eye), twitching, dizziness, stiff neck, head pressure, eye pain, ear pain, difficulty swallowing, aspiration, GERD, lack of appetite. I also had massive increase in spider veins, nail ridges, constant wrinkled fingers, nail growh abnormalities.

    It’s 9 montsh later and I still can’t walk far, howver I do feel I have recovered from other symptoms about 70-80% and am left with only a few symptoms now (about 5). But I am really lucky because there are thousands of people out there that never recover to the degree I have… I wish I could go back to sports but I feel this might never happen until good enough regenerative medicine can fix the damage Bayer [company that makes cipro] has done to me.

    I cannot believe this happened to me, especially considering just how active and healthy I was days or even hours prior to my first dose of cipro. I was also ‘floxed’ on my birthday.

  • I would encourage you to look at this site where lots of people have shared their reaction

    http://latimesblogs.latimes.com/booster_shots/2008/07/cipro-joins-the.html

  • Ty Taylor

    Mr. Newman,
    I believe I am the person you are referring to when you said you spoke to a South Florida man who experienced three tendon ruptures after taking a fluoroquinolone. I had forwarded spreadsheets regarding the number of tendon ruptures reported to the FDA for Dr. Sidney Wolfe to review. They showed that the number of tendon ruptures that both the FDA and the numbers your organization were using were incorrect. The numbers of cases are actually much higher. Even the numbers reported from other counties in clinical data are showing this to be factual.

    My reasoning for getting you the correct data was because I thought it would be easier to get the black box warning. Secondly, I was worried that if you were successful the media would pick up the numbers you were stating and run with it. This exactly came to fruition. Of the countless media stories that went published were nothing more than a cut and paste job of your press release using the incorrect numbers.

    Since speaking to you I have sent both the Cipro and Levaquin files to Kate Resnevic. I even offered to buy the additional spreadsheets on the remaining fluoroquinolones so that the number of ruptures and tendonitis would reflect what had been reported to the FDA.
    The reply to this offer:

    I don’t think that will be necessary. I’ve sent the spreadsheets to Liz Barbehenn, a toxicologist on staff who pulled our numbers, and she’s looking into it. I’ve also informed the director of the Health Research Group, Dr. Sidney Wolfe, of your findings.

    I’ll let you know as soon as I hear what’s going on.

    Thanks,

    Kate

    I had hoped that a data analyst would have reviewed this. The FDA/Medwatch system is so outdated that it should be completely scrapped. They have even admitted to me how difficult it is to navigate and do a search.

    On July 8th we at least got a black box warning, which most doctors are already calling unnecessary. Also on the same day, I had that third tendon reattached. After 3 months of recovery, I get to go in and have my fourth tendon reattached.

    I am sure you are aware that there are many other ADR’s that come along with this class of drugs. If not please go over the Medwatch reports. I do suffer from many of them but consider myself one of the lucky ones. So far my heart, liver, kidneys, eyes and other vital organs have not been attacked.

    Thank you for taking time to read this
    Ty Taylor

  • Mr. Nueman,

    I would now find it to be an unpardonable sin should Public Citizen decide to abandon these patients by failing to take this as far as possible within the Federal Court System. I would hate to think that our one and only advocate would decide to abandon us in the same fashion as the medical community has. I beg pardon to even post this long comment, but as the patient whose life had been destroyed as a direct result of these drugs, I feel that I have paid the price in blood and have earned the right to do so.

    Black Box Warnings, Dear Doctor Letters, restrictions place on the use of Avelox, thousands of patients responding to these articles claiming severe injuries from this class, hundreds if not thousands of adverse drug reaction forums with tens of thousands of members world wide, as well as more than fifty percent of these drugs removed from clinical practice, and last but not least the fact that Nalidixic Acid, upon which all these drugs are based is a listed cancer causing agent, I dare to ask: are we still to believe the following comment which can be found at the end of just about any article written about this class? ‘The fluoroquinolones as a class are generally well tolerated; most adverse effects are mild in severity, self-limited, and rarely result in treatment discontinuation…’

    Or are we to continue wonder if we are the only ones who have bothered to do any research on this class in the past twenty six years? For surely who ever would make such a claim has not. “Repeat a lie a thousand times and it becomes the truth …” – usually credited to Dr Joseph Goebbels, Propaganda Minister of the Third Reich. I now credit it to those medical researchers who continue to state how safe and effective this class of chemotherapuetic agents are. For they have repeated this lie a thousand times a thousand times. Rather odd coincident that they are both (Goebbels, and these medical researchers who state such blatant lies) members of the medical community.

    But in spite of this horrendous safety profile that has been associated with this class for over two and one half decades now, we find within an article written by MELISSA McEVER/Valley Morning Star, (July 18, 2008 ) it being stated that local physicians say they still plan to prescribe the antibiotic Cipro and similar drugs despite the government’s recent warning that the medicines could cause tendon infections and rupture. Surely does not get any sicker than that.

    But I too do not advocate the total banning of this class. When the physician is faced with a serious infection that may result in the loss of life or limb if not properly treated, the such a drug needs to be found within their black bags. You have no choice but to hit hard,and hit fast, with the most potent drug at your disposal. And then retire to the chapel with the family and pray it works. Efficacy is not being discussed here and for the most part irrelevant to the discussion at hand. What is being discussed is the failure to warn.

    As such, being a reasonable person, what I do advocate, and I would hope that you share this concern as well, is for the patient to receive adequate warnings concerning it’s true safety profile. Which simply does not take place with this class, and never has.

    The Black Box Warnings we now see are to be considered far too little, far too late, and a ‘slap to the face’ to those of use who have suffered needlessly due to this gross malfesance by the FDA for over two and one half decades.

    I would hope that Public Citizen does not in any way, shape, or form, consider this to be the proper response from the FDA and continues to pursue this matter until such time that adequate warnings are included in the package inserts, which would mandate numerous other Black Box Warnings being added as well concerning the other adverse reactions which are far more serious, and even life threatening, than spontaneous tendon ruptures.

    One may ask, and with good reason, what facts I base such an assertion(s) upon. Perhaps this editorial posted in response to a propaganda video presented by a John Hopkins physician on MedScape, in a blatant, and buffonish attempt at ‘damage control’ would be found to be a sufficient answer.

    Though quite lengthy I believe it conveys the concerns that those of us who have our lives destroyed by the rampant scripting abuse associate with this class, as well as the outrageous ignorance found within the medical community provides a sufficient answer:

    What is behind the ignorance and denial found within the medical community regarding the true safety profile of the fluoroquinolones?

    An editorial in response to the FDA’s recent addition of “Black Box Warnings” to the fluoroquinolone class.
    Written by the Director of the Fluoroquinolone Toxicity Research Foundation, Mr. David T. Fuller.

    The Fluoroquinolone Toxicity Research Foundation continues to collect post-marketing reports regarding the non-abating nature of the severe and crippling adverse drug reactions associated with fluoroquinolone therapy via the Internet. Ever since the research forum went on line, the Fluoroquinolone Toxicity Research Forum hosted by Yahoo has received thousands of reports, including numerous associated fatalities. The homepage for the Fluoroquinolone Toxicity Research Foundation, http://www.fqresearch.org has accumulated over 4000 medical journal entries, newspaper articles, post marketing reports, lawsuits and other such supporting data the clearly shows the rampant ignorance and denial within the medical community regarding the non-abating nature of such events.

    For more than forty years, since the introduction of Nalidixic Acid in 1962, the victims of fluoroquinolone toxicity have been denied the medical care they so desperately need as their physicians have routinely failed to recognize, treat and report such events. Peripheral Neuropathy, spontaneous tendon rupture, severe and non abating joint and tendon damage, resulting from such toxicity, are all known, listed and published adverse drug reactions to these chemotherapeutic agents, commonly referred to as fluoroquinolones or quinolones. Yet the victims continue to be told by their physicians “it cannot be the drug”.

    Numerous news stories since the anthrax scare back in 2001 have documented such injuries, with the most recent being the death of the daughter of one member of the research forum, whose death was the direct result of such careless scripting of these toxic and dangerous drugs. Another forum, the quinolone adverse drug reaction forum, hosted by Yahoo since February 14, 1999, has accumulated over 57,000 such post regarding the damage this class of chemotherapeutic agents can and will do. The law firm of Sheller, Ludwig and Badey, one of the largest class action and medical malpractice firm in the Northeast, had filed a class action lawsuit against Bayer AG, the manufacturer of Cipro. This suit was filed on behalf of all those who have suffered such damage including the Capitol Hill Staff, the Washington Postal Workers, and the employees of the American Media who were exposed to Ciprofloxacin as a result of the Anthrax Scare. This suit was later withdrawn alleged to be the result of the astronomical cost of such litigation.

    In spite of the overwhelming evidence of the non-abating nature of such injuries, the FDA continues to approve new drugs within this class together with new indications for those already on the market. Ignoring the 9,711 reports that include 806 associated deaths and 39,128 total reactions found within the AERS reports for Levofloxacin. (Levaquin Nov. 1997 – May 30, 2007) In 2004 these numbers were 5,276 reports, 473 associated deaths and 19,792 total reactions respectively. Together with the 8,766 reports which include 837 associated deaths and 40,395 total reactions for Ciprofloxacin found within the AERS reports as well. (Nov. 1, 1997 – June 5, 2007) Where as these numbers were 4,995 reports, 480 associated deaths and 20,890 total reactions in 2004. As well as the following:

    Floxin: Nov. 1997 – May 30, 2007
    Total reactions: 13,495
    Total death outcomes by case: 311
    Total individual safety reports: 2,962

    Proquin (ciprofloxacin) Nov. 1, 1997 – June 5, 2007
    Total reactions: 40,151
    Total death outcomes by case: 831
    Total individual safety reports: 8,688

    Tequin: Nov. 1997 – June 5, 2007
    Total reactions: 15,494
    Total death outcomes by case: 196
    Total individual safety reports: 5,307

    Factive: Nov. 1997 – June 5, 2007
    Total reactions: 1,979
    Total death outcomes by case: 7
    Total individual safety reports: 1,108

    Avelox: Nov. 1997 – June 5, 2007
    Total reactions: 30,160
    Total death outcomes by case: 337
    Total individual safety reports: 7,391

    Almost fifty percent of such chemotherapeutic agents have been removed from clinical practice or their use severely curtailed, due to toxicity issues. Yet, Mr. MacCarthy, the 2001 Vice President of U.S. Medical Science at Bayer’s West Haven facility stated in 2001″If you are telling me that someone had these effects and they were persisting, long term, months to years after treatment I would be surprised.”

    The members of the Fluoroquinolone Toxicity Research Foundation had been telling Mr. MacCarthy’s employer exactly that for years prior to him making such a statement to the press. Those within the media who have an interest in interviewing those who “had these effects and they were persisting, long term, months to years after treatment” are welcomed to visit our website and forum. For we state unequivocally that Mr. MacCarthy was being less than forthright in the statements he had made back in 2001. Such documentation has been made available to the firm he works for year after year.

    The adverse reactions experienced by the members have shown to be both persistent and non-abating, “year after year”, contrary to what Mr. MacCarthy had stated publicly. As one member of the forum so eloquently stated, “Mr. MacCarthy is mistakened”(sic) as we have the documentation as well as hundreds of such victims to prove all that we state here which is available for public scrutiny.”

    Those within the media who have an interest in interviewing those who “had these effects and they were persisting, long term, months to years after treatment” are welcomed to visit this any one of the thousands of such websites found on the Internet as well. Mr. MacCarthy apparently could not be bothered to take the time to do so prior to making the comments that he had in 2001, in my humble opinion.

    Here we are SEVEN years later, and we still continue to hear such denials from the manufacturers and the medical community even though these numbers have increased dramatically. Levaquin has been reported as having the most numerous, non-abating and severe adverse drug reactions associated with its use on Mediciations.com

    A review of the online adverse drug reaction reporting forum: http://www.Medications.com (October 2002 – February 2004) revealed that Levaquin was associated with approximately 17% of ALL adverse drug reactions being reported to this site, irregardless of the drug being reported upon. Medications.com started receiving such reports as of October of 2002. Medications.com is an Internet community that allows people interested in commonly prescribed drugs to interact so that they can discuss the implications — both positive and negative of using these important tools in modern medicine. Medications.com list over 4,500 drugs in common use to date, users have posted thousands of side effects and messages about many of these drugs.

    The total number of adverse reactions, regardless of the drug mentioned, as of 2-11-2004, totals approximately 4,469. Levaquin, by far, received more such post than ANY other fluoroquinolone drug listed on this site. Of the 774 adverse reactions reported for all of the fluoroquinolones listed, 752 were for Levaquin. The only fatality listed for a fluoroquinolone was for Levaquin. 97.5% of all adverse reactions to the fluoroquinolones were reported for Levaquin. As such reports are received anonymously the verification of such reports was not feasible nor did we attempt this. But one can assume that receiving this many reports over a sixteen-month period that the majority of such reports are indeed valid. This study also lacks the necessary controls required to present the above as fact and as such should be viewed for debating purposes only.

    A review of the side effects posted on Medications.com (October 2002 – February 2004) for the fluoroquinolones used in clinical practice in the United States revealed the following:

    Avelox 8 post
    Ciprofloxacin 7 post
    Floxin 5 post
    Levaquin 752 post w/(1) fatality
    Tequin 2 post

    The predominate adverse reactions reported for Levaquin are as follows:

    Nuerotoxicity
    Tendon Damage and or rupture
    Insomnia
    Non abating injury (multiskeletical)
    Peripheral Neuropathy
    Gastrointestinal
    Anxiety and Panic attacks
    Vision Problems
    Rash, sweats, taste perversions, hearing loss

    ALL of which those who suffer such reactions are being told by the treating physician to have no association with fluoroquinolone therapy. This trend is repeated on a number of adverse drug reaction forums dealing with the adverse drug reactions as they relate to the Fluoroquinolones. As the above data has not been verified other than visiting this site and doing a physical count the absolute accuracy has not been determined.

    Since the time that this analysis was performed the numbers have increased so dramatically to the point that it is no longer feasible to even attempt such a comparison today. And yet the NUMBER ONE drug with the most adverse reactions, as well as the most severe adverse reactions, continues to be levaquin on that site.

    In spite of the overwhelming evidence presented at that 62 Meeting of the Anti-Infective Drugs Advisory Committee that the fluoroquinolones cause irreversible joint damage in the pediatric population the FDA has recently added the use of Ciprofloxacin in the pediatric population, Treating children as young as one years of age. We are currently faced with a clear and present danger regarding these drugs as the FDA, ignoring the tragic results of such careless scripting, has now authorized this use knowing full well that the physician will continue to abuse their discretion.

    I challenge the FDA to explain to me how they expect a child who cannot even walk or talk yet to register a complaint of joint and tendon pain. Numerous studies have indicated that such use in a pediatric patient runs the risk of crippling the child for life. One such patient has undergone numerous surgeries to repair this damage and remains crippled to this day. Yet additional clinical trials continue aided and abetted by the FDA, for other drugs in this class other than Ciprofloxacin. A disaster that is detailed within the 62nd meeting of the Anti-Infective Drugs Advisory Committee where it was so eloquently stated:

    “…when we talk about the issue of arthropathy that potentially includes a number of things, ranging from simple effusion, for instance, of a knee joint, which might rapidly resolve after the conclusion of therapy, to a more permanent disability. ..” (sic)

    “…in September of 1997 there is now a ciprofloxacin suspension which is available, and although it continues to have the same warning statements about arthropathy in juvenile animals and the potential concern in pediatric populations, obviously, the issue of off label use will extend over to pediatric populations in this formulation….”(sic)

    “…An important safety question is, what adverse events should be monitored, and Doctor Goldberger alluded to this earlier. This is some of the examples I present. One is permanent lameness, reversible lameness, joint effusion, joint pain, and even latent articular disease or damage that may occur months or years following drug exposure, and there may be others….”(sic)

    “…And, data submitted to the Agency, as well as data from the scientific literature, indicate that these lesions don’t appear to be reversible…”(sic)

    “…Doctor Stahlmann in Berlin is working on an idea that it may be an effect between the endocrines, the magnesium and the matrix and the quinolone. And that data is just coming out now. But as to the exact mechanism, I think you’re right. I don’t think we have a handle, as far as I know, on the exact mechanism. If there’s anybody else that does, I’d sure like to hear it…”(sic)

    “… Relating your personal experience, I was wondering about the potential for a delayed effect that in fact one might have a patient who had some histologic changes that would not be manifest clinically for many years. Is that a potential?” (sic)

    “… I think it is a potential…”(sic)

    “… In trying to assess toxicity with a very sensitive assay, obviously you’ve got tissue that you can look at in your animal models. There is some human data that were collected by Doctor Urs Schaad using MRI scanning in children and I’m wondering if you can correlate some of your histopathologic findings with MR in the animal model to give us an idea of how sensitive it would be sort of as a follow-up to Doctor Klein’s question is the MR something that will be able to predict long-term outcomes, even if there are no clinical symptoms during therapy….”(sic)

    “… That I don’t know. I’ll just be perfectly frank. I don’t know. But on the slides I’ve seen from the animals from the chronic study, the repaired articular cartilage that is there is principally fibrocartilage yet it will provide the same joint margin and it has a calcified base and when we stain it with safrain O screen there’s no proteoglycans there so it’s going to make it an extremely chondromalaistic area and beyond the one year I can’t tell you what the results will be…”(sic)

    “…Anyway, it was by a group in Vienna where they looked at the articular cartilage of postmortem specimens of articular cartilage from kids with cystic fibrosis that had been on quinolones for a period of time and they found that there was damage in the chondrocytes….”(sic)

    “…There were no deaths reported in U.S. pediatric zero to 18 year old cases where a flouroquinolone was reported as the suspect drug. However, there are eight deaths in the whole cohort of suspect and concomitant flouroquinolone drug reports in the system. Five of these deaths reported ciprofloxacin as a concomitant drug and not the suspect drug. These five were U.S. cases with ages ranging from seven months to six years. The remaining three deaths were all foreign, all 18 year old patients with either ofloxacin or norfloxacin reported as the suspect drug….”(sic)

    “…There are 14 reports of arthropathy or arthralgia in the pediatric zero to 18 year old flouroquinolone reports. One report of a 14 year old girl had both ofloxacin and lomefloxacin as the suspect drug so there is an extra count because of the two flouroquinolones on this one report. This particular report indicates that a pediatric orthopedic surgeon diagnosed femoral anteversion as the cause for the girl’s arthralgia, therefore you see it listed twice, and not the flouroquinolones. Most of the reports indicated that either an involved knee or elbow with or without other joints was involved….”(sic)

    “…One interesting case which is not included on this slide for arthralgias was a 15 year old boy who received ofloxacin IV for an emergency appendectomy and had not grown more than his 70 inches in height over the last year. The 15th percentile for height for a 15 year old boy however is 66.5 inches and the expected growth rate is about two inches per year…”(sic)

    “…Three patients had their seizure after the first dose of flouroquinolone, one on ciprofloxacin and the other two on ofloxacin, one of which had received ofloxacin several months earlier…”(sic)

    “…The 15 psychiatric reports are a loose grouping of reports which include events ranging from euphoria to psychosis. The ages range from five to 18 years with the median at 15 years. There were two suicide attempts, one on ofloxacin and the other on norfloxacin, three reports of hallucination, one each on ciprofloxacin, ofloxacin and norfloxacin, and one report of aggressive behavior with confusion in a patient who had a psychiatric history and was on norfloxacin. The seven cases of photosensitivity were reported with lomefloxacin with one case on ciprofloxacin and two cases on ofloxacin. …”(sic)

    “…I will mention that there were 152 U.S. cases aged zero to 18 years in the U.S. AERS system suspect flouroquinolones in the WHO line listing. The country with the most pediatric reports in the WHO foreign reports is the United Kingdom with 177 reports followed by Germany with 72 and France with 71. The rest of the countries had 20 or fewer reports….”(sic)

    “…And with regards to muscular-skeletal events, 21 percent of the patients had an event in ciprofloxacin…”(sic)

    “…We have focused our analysis on joint disorders and pefloxacin. 79 cases were reported and consist mainly of arthralgia. I don’t know the pronunciation of hydrarthrosis — 49 persons. It involved the knee in 52 cases, the wrist in 20 cases, the elbow in 20 cases, the shoulder in 6 cases, the ankle in 5 cases, and the hip once. It is associated with a functional discomfort in all cases, and when the duration of this discomfort is known, it can persist more than one month in 61 percent of these cases. But the outcome was favorable in 58 cases without discontinuation in two cases. …”(sic)

    “…There have been sequelae in three cases with knee effusions persisting one year later in one case with discomfort following 8 months later in the second case. The third case is articular. It is a 17-year-old patient who experienced arthropathy and the drug was not suspected and the treatment was continued two following months. It leads to destructive arthropathy of the knees and the hip and prothesis was performed three years later. He was treated for a cerebral abscess. The outcome was unknown in 18 cases. In 9 cases, there was no follow-up. In the 9 last cases, we had a follow-up three months later and patients were not — were still with disabilities and after we have no evolution….” (sic)

    “… It is my understanding that one of the children had a joint replacement, is that correct?”
    “ Pardon me?”
    “ One of the children with the complications had an artificial joint replacement?”
    “Yes.”
    “…If an irreversible cartilaginous lesion can occur, it is very likely that is going to cause problems down the line and we can’t even anticipate what they are like…” (sic)

    In spite of the following proven horrendous side effects:

    Permanent disability
    Permanent lameness
    Joint effusion
    Joint pain
    Latent articular disease or damage that may occur months or years following drug exposure
    Lesions that don’t appear to be reversible
    Potential for a delayed effect that would not be manifest clinically for many years
    Damage in the chondrocytes
    Eight deaths (five of which involved Ciprofloxacin)
    14 reports of arthropathy
    Seizures
    Stunted growth
    Suicide attempts
    Hallucinations
    Photosensitivity
    Knee effusions persisting one year later with destructive arthropathy of the knees and the hip
    (And with regards to muscular-skeletal events, 21 percent of the patients had an event in
    Ciprofloxacin)
    As one member of this advisory committee stated “…If an irreversible cartilaginous lesion can occur, it is very likely that is going to cause problems down the line and we can’t even anticipate what they are like…”

    How is it that the victims can now ‘anticipate what they are like…’ while the FDA has no idea what risk these children face nor how to treat such events once they occur twelve years later?

    Yet in conclusion this committee stated “…We clearly want to encourage development of these drug for use in pediatrics…”.

    Within the newest package insert for Ciprofloxacin we find peripheral neuropathy being added as a severe, non-abating adverse drug reaction. A disease state in which the peripheral nerves are so badly damaged the patient will spend the rest of their natural life in severe, non-abating pain for there is no treatment protocol available for such a disease state that offers any relief. But we see no “Black Box Warning” concerning this. Of additional concern is the fact that there are also ongoing clinical trials regarding the use of other chemotherapeutic agents within this class involving pediatric patients as young as six months of age.

    For more than forty years since the introduction of Nalidixic Acid in 1962, severe and permanent injury to the patient has been documented. Not one year in the past twenty six has gone by without additional articles being published in the leading medical journals documenting the horrendous damage these drugs can and will do since the introduction of Nalidixic Acic. Now the FDA has given their blessing on the use of chemotherapeutic agents within the pediatric population.

    The use of these drugs will NOT be restricted to the approved indications either. The FDA has stated “…obviously, the issue of off label use will extend over to pediatric populations …” So now a child with a minor ear ache or sore throat will risk being crippled for the rest of their lives and the FDA will continue to turn a blind eye to such abuse for it is NOT within the legal rights of the FDA to control how such drugs are used once they have been approved. The FDA has no say in the manner in which a physician chooses to utilized a drug once it has been approved.

    As such we now look forward to a whole generation of pediatric patients being destroyed by the careless manner in which such drugs are utilized and the treating physician will continue to fail to recognize, treat and report such events. Just as they have been doing for the past forty six years. Numerous forums now exist on the Internet in which the adult patients have been reporting such severe reactions since 1999. We can all now look forward to the distraught parents of these children joining such forums as a direct result of this total and complete failure of the FDA to protect the health and welfare of the pediatric population. Ignoring their own research and the findings of their advisory committee, they have approved a proven dangerous and toxic drug for the use in children.

    The Fluoroquinolone Toxicity Research Foundation continues to collect post-marketing reports regarding the non-abating nature of the severe and crippling (and at times fatal) adverse drug reactions associated with fluoroquinolone therapy via the Internet. Since one of the first such forums went on line back in 1999, over nine years worth of horror stories regarding the damage these drugs can and will do have been forwarded to the FDA. In spite of the overwhelming evidence of such severe and at times fatal adverse reactions, the FDA continues to refuse to take action.

    In a letter we received from the FDA, (circa 2004) Frances T. Gipson, FACHE Office of Executive Programs Center for Drug Evaluation and Research, stated that “…we will weigh all risks and benefits associated with Fluoroquinolone Class Drugs prior to taking any additional action…We will continue to monitor future adverse events reported to us.” To add insult to injury regarding such inaction by the FDA, Gipson also states “…It was also noted that the majority of those adverse events reported are well-known side effects of the Fluoroquinolone class of drugs…” Three years later (circa 2007) they are STILL ‘monitoring’ such events and Public Citizen received a reply from the FDA to their petition seeking Black Box Warnings stating the very same thing almost word for word. So did the Attorney General of the State of Illinois in response to their petition filed a year earlier.

    For more than forty six years, since the introduction of Nalidixic Acid in 1962, the victims of fluoroquinolone toxicity have been reporting such “well-known side effects”, only to be denied the medical care they so desperately need as their physicians have routinely failed to recognize, treat and report such events. Peripheral Neuropathy, spontaneous tendon rupture, severe and non abating joint and tendon damage, as well as fatalities resulting from such toxicity, are all known, listed and published adverse drug reactions to these chemotherapeutic agents, commonly referred to as fluoroquinolones or quinolones. Yet the victims continue to be told by their physicians “it cannot be the drug” and the FDA continues to “monitor future adverse events.” It surely does not get any sicker than this.

    Numerous sites continue to be added to the Internet dealing with these reactions in an effort to draw media attention to those of us who are left outside the city gates, like lepers to be pitied and ignored. On any one of these sites you will find tens of thousands of case histories, posted in the very words of the victims themselves, which describe the horrific suffering they or their loved ones have endured as a direct result of the FDA’s failure to prevent such carnage. You will also find postings regarding those who have forfeited their lives due to the rampant ignorance regarding the adverse reactions associated with these chemotherapeutic agents.

    The recent addition of this frivolous “Black Box Warning” only emphasizes the fact that such adverse reactions experienced by such victims have shown to be both persistent and non-abating, “year after year”, contrary to what Mr. MacCarthy had stated publicly seven years ago. The comments made within the video presented by the good doctor from John Hopkins emphasizes the fact that NOTHING has changed since then either when it comes to the rampant ignorance found within the medical community.

    Since 1999, over nine years ago, we now have added over fifteen different sites to the Internet that deals with these issues. All dealing with what Mr. MacCarthy claimed to have no knowledge of. Perhaps he may wish to read the postings under “In Fond Memory Of” on the fqvictims site. It has been stated that “dead men tell no tales” but thanks to the efforts of those involved with bringing this new site on line; they have been given a chance to do exactly that. For you will find post after post detailing the horrendous manner in which such fatalities related to the careless and thoughtless use of these dangerous drugs, have occurred. No doubt Mr. MacCarthy has no knowledge of the permanent nature of such reactions either. Over a thousand documented fatalities, forty thousand severe adverse reactions, four thousand medical journal entries, fifteen new adverse reaction websites, nine years worth of post marketing reports, and the FDA continues to state that they intend to “continue to monitor future adverse events reported to us”. The victims continue to report the carnage, yet no one is listening. Perhaps with this “new” warning, somebody, somewhere, will. But somehow I rather doubt that we will find that they work at the FDA.

    You would also note that Internet sites that published this new warning and allowed people to post a comment have been overwhelmed with patient’s complaints. I rather doubt that this would be taking place unless the drug in question is truly defective. People have far better things to do with their time I would imagine.

    Mr. David T. Fuller
    Director
    Fluoroquinolone Toxicity Research Foundation
    http://www.fqreseach.org
    fqresearch@aol.com
    davidtfull@aol.com

    About the Fluoroquinolone Toxicity Research Foundation

    The foundation is a non profit organization consisting of those who have suffered irreversible and non-abating injury as a direct result of fluoroquinolone therapy. The foundation is dedicated to presenting the research regarding these issues in the hope of preventing such injury to others and to make such research readily available to those who have shown a prior interest. We strive to present accurate and up to date information to the victims of such scripting abuse so that they may be in a position to receive the medical care such rampant ignorance has denied them. Such documentation is readily available via the forum or the homepage http://www.fqresearch.org

    The author of this Editorial (and comment) has NO financial ties whatsoever with anyone found within the legal or medical field. There are no known conflicts of interest to disclose, and the Foundation has never accepted any donations, of any kind, from any person, corporation, or special interest group since it’s inception.

  • You have wonder if the FDA could have spared him some grief if it hadn’t taken so long to act.

    Perhaps if they acted properly way back in 1982 there would be no wondering about it.

    I would hope that Public Citizen does not accept this rotten bone being tossed to them by FDA as full satisfaction and accord. But would rather pursue the issue of insignificant and grossly inadequate warnings concerning the far more serious reactions associated with this class. Events such as:

    Irreversible peripheral nueropathy
    Loss of vision and hearing
    Unrelenting pain
    Fatal damage to the heart, liver and kidneys
    Fatal hyper/hypoglycemia
    SJS and TEN

    For Public Citizen not to demand Black Box Warnings concerning these events I would believe to result in those who have suffered such reactions being abandonded by our one and only advocate in the same fashion as they have by the FDA and medical community for the past two and one half decades.

    Are we now to expect to wait another twenty five years for such warnings while crippling and killing other patients? Something I would find to be totally and completely unacceptable. Or will Public Citizen continue to pursue this in Federal Court until such time that fair and adequate warnings are available to both the patient as well as the treating physician?

    It has already been reported that the medical community intends to ignore this Black Box warning and continue to use and abuse these drugs. So who now will step up to the plate to put a screeching halt to this carnage if NOT Public Citizen? We have no else to turn to. We have tried for over twenty five years now with little to no success.

  • Christine

    After only taking 3 levaquin pills my life has not been the same IT has been over a year. Actually one year 5 months since I took the last pill. On the 3 day I had sever muscle pain spasm. IT took about 3-4 months for me to be able to walk then my achiiless in both legs went I can not stand for more then a couple of minutes and I can walk once around the block. I am missing out on everything. I wish there was a warning on the meds because I would of asked for something else. There are plenty of meds that can be given for a uti.

    I ask that we are not forgotten about, and something more has to be done because this is a sin that it has robbed us of out precious time here.

    Shame on the FDA

  • ciprovictimalso

    I still remember quite well the night my husband put a loaded .38 revolver in his mouth and pulled the trigger. I found him slumped over with clumps of tissue and blood coming out of his mouth. I have a police report that this happened. This occurred after taking Cipro. He never had a suicide attempt in his life before taking this awful medicine. He survived that attempt, but found other ways to try to commit suicide that were more frightening. He was not only strong but also intelligent before all this happened. I have been emailed by several people who believe Cipro caused their loved ones to commit suicide. I still have their emails. I’m very grateful my husband is still alive. Tendinitis and tendon ruptures seem to dominate the warnings, but what about the other more serious adverse reactions. How many people does it take to commit suicide before it becomes important enough to be more recognized? So many people are suffering from severe depression caused by these medicines. These medicines do something horrible to people that makes them change from who they once were. What about the neuropathies, severe muscle and joint pain and so many other adverse reactions. Please stop this from happening to others.

  • Brenda

    I have been a victum of Cipro for 6 year’s. It started when I went into the hospital 6 year’s ago with double phenominia in 2002.
    It was May 13th of 2002 I had double phenominia and had to be transfered from my home town to St.Louis University in
    St.louis Mo and all I remember is being in the emergency room.I woke up and was waiting for the Dr to come in my room
    to check me and admit me . And the people kept walking by so I was going to push the buttom to get a nurse
    in the room .But I noticed I could not move my hand’s.I looked down and my hand’s where strapped to the bed. So I yelled and
    yelled and got no one to come in the room so I decided to get there attention one way . I had a tray at the bottom of my bed so I
    had to kick it and I heard someone talking to me. And I yelled at them I needed help. I looked around and seen they had a monitor
    on the wall to watch me.I finally got someone to come in my room and ask why haven’t I seen the Dr yet.And they said
    you have, so I ask why where my hand’s tied to the bed and they told me it was to make sure I did not get out of bed and no one
    knowing. I ask they why,they said I had been very sick and I had to stay in bed.They told me I have been in a coma for 5 1/2
    week’s.So I ask them why I was in a coma and they told me I was so sick and had such a high fever and the Dr.did not
    know what was wrong with me and I was getting worse so they put me in a coma. I do not remember any of this but entering the
    emergency room. So I had to learn how to walk and eat and take my med’s. I had to have my hair cut off because it
    was matted up from laying on my back for so long. I had seizure’s while in a coma about 3 from whay I was told they said
    they where so bad I shook the bed real bad. And I swole up twice the size of my normal size.From fluid build up. I went
    home and the next day I was right back in the hospital because one if the med’s they gave me make me sick again. So I
    was in for a week longer, Well I got out on the 4 of JUly 2002.I had to stay in St.louis jusy in case sometthing happen again
    for a while I had IV treatments at home I had a centeral line in my arm for week’s.
    Well in the last 6 year’s I have went to Dr after Dr to find out why i was in so much pain and I have no smell,very little taste,
    loss of appitite,brain fog,memory loss,headache’s,ringing in my ear’s,blurred vision,insominia,hive’s ,breathing problem’s,joint
    stiffness,muscle pain,weakness, painin extremeties,jaw pain,chest pain,gout,skin problem’sseizures,easy brusing and bleeding,
    oanic attacks anexity,bloating,vibration through body,speech problems.cant stand bright light. and so on ………
    It has messed up my whole life. I can not plan on going anywhere’s for any period of time because i do not know how bad I
    may feel the next day or if I will even be able to get out of the house.I have been on this daily Cipro 500 mg for 6 year’s.
    just to try to stay alive and look what it has done to me in the long run it has taken away my life and put me in pain,
    Some day’s I would just as soon be dead.I am unable to move and the pain is so bad and my memory is so bad.I do not
    even drive anymore because i do not trust my self.I have had to have someone to come and clean my house
    I can not even do much of it any more.I know my family get’s upset with me but I cannot help it.
    IT IS ALL DUE TO THE CIPRO AND TODAY MY JAW’S HURT SO BAD I HAD SO MUCH PAIN IN THE I COULD NOT EVEN EAT…
    I GUESS THIS IS PART OF THE CIPRO ALSO I WONDER WHAT WILL KEEP COMING UP FOR ME TO HANDLE NEXT…….
    I HOPE NOT MUCH I HAVE ALL I CAN HANDLE NOW AND MOST DAY’S IT IS TOO MUCH.So someone need to do something about the Bayer Co not black boxing the medication year’s ago and letting all of us who has taken it end up in so much pain and suffering.It scares me knowing this medication is aldo used for anthrax……How scarey is this to you. This is messed up my whole life and my family My family has to pay for this also they do not have a mom who can be a normal mom or be a grandparent . IT MAKES ME SICK……………………………………………………….

  • After a round of fluorquinolones I was just playing guitar, bent a string and a tendon in my hand ripped.

    This crap needs to come off the market.

  • Gary TBY

    Cipro has effectively ruined my life. I can no longer do all the things I used to love to do. I can’t even work for a couple of hrs. now without excruciating pain for the next few days. I can’t hike or hunt or go fishing like I used to. This constant pain and suffering has put me in a deep depression that I had never experienced before. I can’t even get a decent nights sleep without having nightmares that just won’t go away. There are many nights when I just can’t sleep at all without some sort of sleep aid. I used to sleep very well and woke up refreshed and excited for the days activities. Not anymore. I feel like cipro has fried many parts of my CNS and physically has done permanent damage to my joints, blood vessels and organs. I truly believe that cipro has not only shortened my life, but it has also destroyed the quality of the remaining time I have left here on earth. The Fluoroquinolones are toxic crap, and the drug makers have lied about the seriousness and permanence of all these horrible life side effects that happen more frequently than they are saying. It’s a crime against humanity what these drugs have done to thousands of unsuspecting people. I firmly believe FQ’s do way more harm than good to most people that get sucked in to taking them by ignorant Dr’s that don’t realize just how toxic they really are. I am very surprised that someone hasn’t gone postal yet and extracted their pound of flesh for revenge.

  • I was given a gram a day of cipro for a week in March for a UTI, and unfortunately my tendon pains, neuropathy issues, and chest pains have persisted going on almost 5 months now. TOTALLY wasn’t covered in any warning label, and the length of time and severity of this issue is not covered on the black box label either. No one told me this would happen to me.

    It really sucks being out of work and life for so long because I can’t walk.

  • Here is a list of sites that are currently taking comments on this subject. I would invite someone from Public Citizen to take a couple of hours and read what others have to say about these drugs. There are mutiple post of the same comments made by the victims on different sites. This is not due to ‘spamming’ but rather the fact that it took everything they had in them to write their story once, you ask to much of them to do this over and over and over again for each site.

    http://tinyurl.com/5pxom6

    http://tinyurl.com/65h5zv

    http://tinyurl.com/5m5c9t

    http://tinyurl.com/5jo4cz

    http://tinyurl.com/6j5kxw

    http://tinyurl.com/6p4zfe

    http://tinyurl.com/6o8cjd

    http://tinyurl.com/6fs67k

    http://tinyurl.com/6zntlh

    http://tinyurl.com/5e8jzz

    http://tinyurl.com/6aec53

    http://tinyurl.com/6a75sq

    http://tinyurl.com/5758eb

    http://tinyurl.com/5c8xwp

    http://tinyurl.com/59jgbm

    http://tinyurl.com/5mgach

    http://tinyurl.com/558b7e

    http://tinyurl.com/6zon56

    http://tinyurl.com/5o5qxe

    http://tinyurl.com/6dpzaa

    http://tinyurl.com/5hqbxn

    http://tinyurl.com/5rpqvw

    http://tinyurl.com/6694dc

    http://tinyurl.com/5ea8t8
    (direct link to the video)

    http://tinyurl.com/6n6jaa
    (do NOT open this in aol. It may freeze up aol when you try to exit from it. Use explorer instead. If you choose to ignore this advice then before you close the window that contains this video, click on the HOME button at the top of that window first, then attempt to close it.)

    http://tinyurl.com/5pmuvp

    http://tinyurl.com/5wz298

    http://tinyurl.com/6qmflg

    http://tinyurl.com/6fkolk

    http://tinyurl.com/6qtpc8

    http://tinyurl.com/6hvb72

    http://tinyurl.com/58vce4

    I would also invite Public Citizen, as well as those who visit this board, to review the tens of thousands of first person reports, going all the way back to 1999 that detail the horrendous damage and carnage induced by this class that can be found within this link:

    http://tinyurl.com/568tvb

  • Shelley sealover

    Please allow me to C&P my comment. The only thing I have to add is the fact that I have been diagnosed with yet another fluoroquinolone-induced condition: Premature Ventricular Contractions

    I spent yesterday (and overnight) wearing a holter monitor.

    Besides the monitor, I’ve also just had an X-ray of my neck, which has been causing severe pain lately. I am hardly able to hold up my head.

    Thank you.

    Every morning when I open my eyes, I awaken to this nightmare. There is a “sickness” that feels like my body has been poisoned. My hands and feet are swelled and sore…my entire body is stiff and painful…heart-palpitations, vibrations throughout my body…ringing in my ears…bleeding specks of sores on my skin…and a full, bloated feeling in my gut…I feel like I should be dead. It is only by the grace of God, and the love of my 2 children that I am able to pull myself up out of bed, and make it painfully down the stairs. Crying will do no good, as I know I must be strong to fight this horrendous ordeal that has become my life. Knowing that there are others who are living this nightmare gives me a sense of strength…and compassion. There are no more words to described what we are going through emotionally, let alone physically. How could something so unbelievably criminal have happened to us?? And why is this insanity being allowed to continue?? How many more innocent people will have their lives destroyed…how many more must suffer…how many more must die….before something is done?? Someone tell me, what will it take??

    Diagnosed w/ arthralgia, trigeminal neuralgia, tendinitis both elbows, enlarged lymph nodes…
    still seeing doctor after doctor, and specialists who can only treat the “symptoms”, not the cause.

    The Black-Box warning for tendon damage is hardly sufficient and long-overdue.

    The poisons that robbed my children of a mother were AVELOX and LEVAQUIN…20 pills. I traded a sinus infection for this life of pain and misery.

  • nottsfloxed

    After Visiting the GU clinic in Lincoln UK, I took 1000mg for seven
    days of a fifty six day course of offloxacin for bacterial
    prostatitis (now diagnosed Non Bacterial prostatitis) . I had to stop
    the meds due to the intense pain in my knees and shoulders. I was
    diagnosed with Rieters Syndrome and given a thirteen week appointment
    with Urology. After finally waiting the thirteen weeks suffering
    terribly, the urologist at Licoln totally refuted that the GU clinic
    had ever diagnosed Reiters Syndrome and duly diagnosed me with Non Bacterial prostatitis. As for the pain in all my joints i would have to speak to my GP. He diagnosed arthragia but at this point I had the
    following symptoms.
    Severe night time sweats
    Clunking tendons in all joints
    Severe back hip and ankle pain.
    Buzzing in my back and legs
    Bee like stings all over the place.
    Paid to see a Rhuematologist who diagnosed Osteoarthritis due to the lack of inflammation and tendontis due to over exercise. I have had a real shitty 9 months but the floaters in my eyes was the last straw.
    I reseached medication poisoning and found this site.
    Im not mad after all, but after seeing the rhuematologist again you might think it in his eyes.

  • Todd

    I suffered a severe adverse reaction to the fluoroquinolone antibiotic Levaquin myself 22 months ago. Since then I have had daily pain and disability of my nervous and musculoskeletal systems and for several months had endocrine and gastrointestinal problems as well. The disability and damage caused by fluoroquinolones is long term and may gradually escalate in that more severe problems such as worsened neuropathy, neuromuscular disorders, musculoskeletal disorders and endocrine disorders once initiated by the fluoroquinolones may develop with a delayed and insidious progress.

    This progression of the fluoroquinolone toxicity syndrome is well know by its sufferers and not recognized by health care givers. There has been no investigation in to the reactions. This lack of attention stems from of an antiquated FDA reporting system and under-representation of the seriousness and frequency of the adverse reactions. The makers of fluoroquinolones have no interest in investigating adverse reactions when doing so will hurt them financially. It is only recently with the weight of litigation pressing down that the FDA has published its incomplete and grossly inadequate boxed warning about the potential for fluoroquinolone toxicity.

    On a personal level I reported my reaction and concerns to Johnson and Johnson, and the FDA and received minimal response from both of them. It was only after sales diminished in my area that Johnson and Johnson eventually sent a representative to speak with me about my reaction. In no way did they acknowledge the frequency or severity of reactions but were only on a fact finding mission and after visiting me did not follow up on the information I provided them about the adverse reactions. I believe this visit was damage control in response to decreased sales in my community after I had warned my physician colleagues about the reaction.

    I have met many other patients suffering from the adverse effects of fluoroquinolones. Many of them reside in my community including 3 physicians and more than twenty patients. Several of these fluoroquinolone damaged patients were referred to me by colleagues who had heard of my reaction. Although these drugs may be life saving in certain infections when less toxic antibiotics may fail, they have been promoted for use as first line treatment for sinusitis, and urinary tract infections, and are often given indiscriminately to unsuspecting patients by uninformed and cavalier physicians for such benign illnesses as the common upper respiratory infection. Unfortunately for many patients they are trading a mild short term medical problem for a serious long term one.

    Todd Plumb MD

  • It is too little too late.

    I took a fluoroquinolones derivative, and suffered well over 50 symptoms as mentioned by Mr Fuller in his comment.

    Serious healthy issues ensued, such as heart failure, arrytymias, hypothyroidism, life threatening hypo/hyperglycaemia, chronic kidney disease, valve and veins, serious neurological dysfunction causing vestibular symptoms, visual, auditory, olfactory, and damage to the brain stem, shoulders, wrists, fingers, hips and knees inflammation, tendinitis, and other cascading health problems.

    An excellent website for symptoms, info, tips and advice: http://www.fluoroquinolones.org

    For those who need support, information and a safe forum, please visit http://www.favc.info

  • Kelly

    Well, where do I begin.. I was prescribed levaquin back in December 2007 After about three days of being on the medication, I started to feel very jittery, like my whole body was shaking on the inside out. I started getting hot flushes up and down my body that would then turn to chills. I then developed hand tremors which were long lasting and worsened long after I discontinued the medication. I developed extreme weakness in my upper arms and horrible night sweats My lymph nodes became swollen, still are almost 7 months later. I developed tachycardia, my heart beats very fast at resting pulse, and seems to be exacerbated by foods or whenever i eat. My vision became somewhat blurry, and shortly after the medication was stopped I developed an onset of floaters in my right eye. I have never had floaters before in my life, not to mention the fact that I am only 22(went to see eye doctor told me it happens with age, I was 21 at the time..knew I could not convince him otherwise that it was the antibiotics that had caused this. The floaters are probably one of the most debilitating adverse reactions because they are a constant reminder of the damage that has been done. Whenever I go outside or look at a white screen-there they are-huge black spots that look like moving bugs, clumps of cell looking things, and some that look like strands of DNA.
    My physcisian prescribed me levaquin for 14 days 500 mg 1X a day. I was only able to finish 12 days of the medication before I called it quites and could no longer deal with taking it. I have been researching flouroquinoline drugs since about a month after I stopped the medications and came across a YAHOO message board where thousands of people post who have been crippled by these drugs whether it be tendon ruptures, floaters, peripheral neuropathy, you name it. I began thinking maybe these drugs had induced an autoimmune type reaction in me, possibly affecting my thyroid or creating drug induced lupus. There are so many people out there who’s lives are being ruined by this drug, including mine. I am only 22 years old, and I feel as though my life has been ripped away from me. Please help in the stop of these medications being on the market, and help us find a way to fix the damage that so many of us have already encountered!

  • Gary TBY

    On top of all the other health issues Cipro has caused me, I have now been diagnosed with diabetes insipidus and loss of kidney function. I was on top of the world before I took Cipro. It has been all downhill healthwise for the last 2 years starting within 3 days of finishing my 10 day script of Cipro, 500mg. x 2 daily.

    If only my Dr. had warned me of these possible side effects, I wouldn’t have taken it. If only……

  • Leslea

    Please read the comment below that I am posting to every site possible, begging the medical community to stop prescribing this:
    My name is Leslea and I am a Clinical Laboratory Manager, have been a Medical Technologist for almost 30 years. I am very well respected by the medical staff at my facility because if I bring up a subject, perhaps a laboratory protocol that I want to put into place or changed, I have done my homework on the subject.
    With that in mind, I want to urge physicians to take heed to the fact that fluoroquinolones are not safe for a very large segment of the population. There are literally thousands and thousands of people whose lives are forever changed because of the quinolones.
    I know that most, if not all, facilities with microbiology departments put out an antibiogram, at least annually, for the medical staff to reference. Please use your antibiograms to pick the least toxic and most effective antibiotic for your patient.
    Use the quinolone class only as a last resort, after other antibiotics have failed or the patient will expire if they aren’t used. Using the quinolones routinely just doesn’t make sense when other antibiotics will work. Keep in mind if this class of antibiotics continues to be used so nonchalantly they will become ineffective due to bacteria developing resistance to them.
    I have personally experienced multiple system adr’s to the quinolones, and know a multitude of people like me. That is why I am writing this, I want to prevent the number of people that are damaged by quinolones from growing exponentially.
    The adr’s to the quinolones are grossly under reported due to the fact that a lot of reactions aren’t recognized, but are diagnosed as an unrelated problem. If the number of adr’s to quinolones were accurately reported to the medical community, no physician would ever routinely prescribe quinolones again, unless he was some sort of sadist.
    My motivation for writing this is honorable, our term would be risk management in the medical community, for the layperson it would be a passionate desire to prevent others from suffering like I am.
    Just in case you are wondering, my first reaction to a quinolone caused damage to my tendons particularly my left knee. The tendons were so weak that my knee dislocated 6 times over a 7 month period, I probably should have been in a wheel chair, but I needed to work. I have a permanent baker’s cyst in that knee. The tendonitis was so painful that walking was more like hobbling.
    My second reaction made my first reaction seem like a walk in the park. When I mentioned multiple systems earlier, I meant CNS, muscular, skeletal, soft tissues and connective tissue damage. Four and a half years post two doses of Avelox, I still have a multitude of symptoms, some that are not going to resolve. Although I am in severe unrelenting pain, I consider the worst part of my reaction to be the CNS or brain damage.
    I have debilitating depression, which I never had prior to this. But the thing that takes the cake is the following: I am sure you can imagine that I am or actually was above average in intelligence, Avelox has destroyed my short term memory and has made me struggle to find simple everyday words when carrying on a conversation. My nickname used to be “The Steel Trap” because I never forgot anything and could recall verbatim conversations no matter how long or short the amount of time that had elapsed. My memory was what is called photographic in nature. You might be tempted to say, well you are getting older, well I don’t believe that CNS changes due to aging happen overnight unless there is a stroke involved. That, and the fact that I am not alone with this reaction, speaks very loudly to the truth of the matter.
    I will quickly list the other damage I am dealing with; peripheral neuropathy, myofascial damage in my right hip that has lead to permanent gluteus median adhesions after tearing. I have chronic muscle spasms and knots in my right hip and shoulder, this is the cause of the severe unrelenting pain, the shoulder knots and spasms lead to horrible tension headaches. I also have to take Valtrex to keep shingles at bay, another wonderful symptom of the nerve damage. My tendons and ligaments in my right knee are tender to the touch and painful, my vision is altered due to floaters and blurring, luckily laboratories are notoriously noisy so I don’t notice the tinnitus too much. I could go on and on, but you get the picture. By the way, I was a healthy active person prior to this reaction, I was 47 at the time and most people would guess my age at 35 because of my personality, strength and agility, they were always shocked to find out how old I was.
    Please help me in preventing any other healthy individuals from experiencing this nightmare.
    I also challenge you to do your own research into the real picture of this class of antibiotics, quit taking the word of the FDA or pharmaceutical companies, they have an agenda, but it is less than honorable. You can start by going to http://www.fluoroquinolones.org .
    Thank you for your time.

  • Cool. It took almost a day to find this info. Thanks, great job. :)

  • I love your blog…really. Did you already hear about water on mars? :)

  • No blog regarding defective drugs is complete without hearing from the drug reps who have been drinking far too much koolaid. Surprised it took them that long to find this one. Wonder if they were using the water from Mars to make this latest batch of koolaid that they are drinking.

    Water from Mars and a discussion regarding life threatening drug reactions. Only a connection that a drug rep could possibly be making.

  • […] 26, 2008 by Kate Resnevic Ever since we sued the FDA for failing to respond to our August 2006 petition to increase warnings about the risk of tendon […]

  • Peggy Conroh

    The biggest set now should be not just lawsuits but repairing Cipro damage. Any progress here???

  • deathbycipro

    Don’t know of a Cipro or Levaquin victim who has healed yet. I am still up 22 x 7 with ringing in my ears, anhedonia and about 22 other adverse reactions. And some idiot doctor at a college wanted my son to take Levaquin for a runny nose that he thought was a sinus infection? My son has SEEN me and he is too scared to take these drugs. Where are the black boxes?

  • Hal Fisher

    I hope Public Citizen is still pushing this issue. There are plenty of websites devoted to this very real problem. At least a few times a week new harmed people join the Yahoo forums. Don’t stop! Don’t ever stop till they pull this crap from the markets!

  • As of November the FDA FINALLY published the new package inserts on their website which include the pathtetic black box warnings. But a number of brand name fluoroquinolone drugs STILL do not have updated inserts. And forget about the generics. NONE of them have new package inserts published on the FDA site. NOT A ONE OF THEM. Considering the fact that the fluoroquinolones are outrageously expensive you can bet the insurance companies are requiring the generics be used. And what is MISSING from the generic inserts? THE BLACK BOX WARNING OF COURSE. Friggin FDA. Always finding a way to avoid telling the doctors or the patients about how dangerous the drugs they approve are. What a total waste of taxpayers money. And the United States Supreme Court is reviewing a case that would give the drug companies a “get out of jail free card” if the FDA approves their defective products. Doesn’t get any sicker than this…

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