Levaquin and medical community

As many here many recognize, I had tremendous problems after taking Levaquin. This included: distal bicep tendon rupture, a full range of psychological symptoms, extreme and long lasting fatigue, etc. Even after going through this ordeal and still dealing with the fallout almost 2 yrs. later I am once again in disbelief at the medical community. My 18 yr. old daughter just visited a nurse practitioner and came home with a prescription for Levaquin. This alone was enough to make me angry but the fact that it was prescribed for a cold sore (no, I'm not kidding) is just beyond belief! And we wonder why we have the problems we do. Trust no one!

I have taken Cipro & levaquin or several occasions for several years. I DID NOT KNOW OF THE POSSIBLE EFFECTS OF THESE DRUGS ON TENDONS AND OTHER MUSCULOSKELETAL EFFECTS. A FEW DAYS AGO I HEARD A LEGAL AD ON TV WHICH CAUGHT MY ATTENTION: ' IF YOU OR A LOVED ONE HAS TAKEN LEVAQUIN AND SUFFERED A RUPTURED TENDON, CALL....... ' OVER THE PAST FOUR YEARS , I HAVE HAD THREE ROTATOR CUFF INJURIES, TWO OF WHICH REQUIRED SURGERY AND A LONG REHAB, AND A "PROBABLE" TENDON TEAR OF MY FOREARM FOR WHICH I WAS ON LIGHT DUTY FOR SEVERAL MONTHS, REHABBING W/ PT, STEROIDS, BOTH ORAL AND INJECTIONS, ANTI-INFLAMMATORY MEDS. AS MOST OF THESE INJURIES OCCURRED AT WORK- I AM A CCU NURSE- AND WAS TREATED BY OCC MED DOCTORS, AND THEN REFERRED TO SPECIALISTS WHEN I WASN'T GETTING BETTER, I WAS MADE TO FEEL AS IF THESE INJURIES WERE SOMEHOW MY FAULT, THROUGH POOR LIFTING TECHNIQUES,ETC. AT NO TIME DURING ALL THESE TREATMENTS FOR INJURIES DID ANY HEALTHCARE PROVIDER PUT THESE TWO THINGS TOGETHER AND ASK QUESTIONS, AND NOR DID MY OWN PHYSICIAN. THIS WOULD LEAD ME TO BELIEVE THAT THE POSSIBLE SIDE EFFECTS OF THIS DRUG HAS NOT BEEN WELL DISSEMINATED TO THE MEDICAL PROVIDERS.

Comment: 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, 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: 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…”

As such the FDA has no idea what risk these children face nor how to treat such events once they occur.

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) 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

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 www.fqresearch.org

The author of this Editorial 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.

Levaquin is a wonderful drug and one of a very few that help men with prostatitis. If you have ever suffered with a prostatitis infection you know what i mean. No problems here with Leviquin.

It is quite amazing how when the story hits the news, the number of postings here jumps up! How sad it is that many people now realize the same things that many of us have known for quite some time. I only hope that the floodgate have now opened and that everyone will now keep the pressure on to limit the use of thee dangerous chemicals.

After 20 months I have had my right distal tendon surgically repaired, I endure tremendous pain in my left arm daily, and I fight the other unmentionable adrs. A black box warning is a start but it is not nearly enough.

New side effects: intense anger with the FDA and drug manufacturers, distrust of the medical community, and the required development of pain management skills.

It`s very important to educate yourself when it comes to medications.

When I saw people close to me suffer I had to find out why and I am quite sure that it had to to with side effects.

I started to do my own "research" in 2003 and it continues to this day.

One of the groups of medications that I have looked at is quinolone antibiotics to which group Levaquin belongs.

Most medications in this group have similar side effects. For more information go to:

Please visit www.fqresearch.org and www.fqvictims.org (?).

Also search on Google for "floxed" or "floxies". That´s what people call themselves when they suffer from side effects.

I would also recommend Stephen Frieds interesting book "Bitter Pills".

Medications are needed sometimes, but not to the extent that they are prescribed today!

I am a 49 year old male and took a 14 day course of Cipro for a UTI. By day four the souls of my feet were very sore, especially first thing in the morning but no other side effects. Mentioned sore feet to Dr after 7 days of Cipro but he did not believe it was from Cipro and had me complete the course. After 14 day course of Cipro feet were now so painful that I could barely walk on them especially after resting or getting out of bed. Also burning sensation on skin of feet and hands and some minor tremor. Saw a specialist and he immediately confirmed Cipro as the culprit and advised never to take that drug family again. Have since done the whole web search thing and discovered the whole saga of these drugs. Other symptoms have also appeared, some pain in middle of back, sharp pain in middle of back of both knees, hot and cold flushes, pain in left bicep, fingers that are very susceptible to joint injury and feelings of weakness and anxiety. Has been over three weeks now since I stopped Cipro and condition shows no improvement, may even be slightly worse. About to try a shotgun approach with treatment as there appears little documented evidence of anything conclusive on line. Starting course of anti-inflams (Voltaren) and these have already reduced the pain in my feet. Also magnesium and calcium supplements (theory goes that it may mop up any remaining Cipro and there is plenty of reports from sufferers saying that symptoms continue to appear for some months after stopping Cipro), Vitamin B6 (can apparently help with some types of nerve pain and tingling) and Fish Oil (omega 3's can help reduce inflammation). Not very scientific I know and can't be sure that all these are compatible with each other but am a bit desperate at this stage. Bracing myself for a three to six month recovery (just based on experience of many others). At this stage I am just hoping that damage is not irreversible as this appears to be a real risk. As everyone here will agree it is amazing how this situation is being allowed to continue. I could have stopped my Cipro on day two or three if I had been made fully aware of the risks and what to look out for. I am no expert by any means on this but from what I can gather Cipro and its relatives do nerve damage by the very way they work. It appears that anyone taking these drugs will inflict some nerve damage but for many it will not manifest to a degree that is a problem or at least a noticeable problem. So in some ways we are all sufferers, just to varying degrees. Another point mentioned often is that the symptoms may not appear for some months after the Cipro is stopped and therefore is not always associated with the drug. Also some say there is an accumulative affect with using the drug a second or third time. Symptoms may appear only after multiple use or symptoms may get much worse and more likely irreversible with multiple use. It's all scary reading. At this stage I am just hoping I can make a full recovery. Do damaged nerves repair themselves, does the Cipro eventually leech out of our systems .... I don't know. I will post in this forum again in a few months or sooner if I make a recovery.

I am a 36 year-old female, and in very good physical condition. I have been a runner for 15 years. I was prescribed levaquin for a recurrent sinus infection, 500mg x 7 days. On the second day I developed severe carpal tunnel syndrome (tendonitis of the forearms & hands); I could barely hold a pen in my hand, much less write. I refused to take the 3rd dose. On the 5th day (even though I am not taking it anymore) I woke up with severe hip pain (both hips). I can barely walk, much less run. I am a full-time physician and have a small child. I am not sure what will happen to my favorite hobby, running. This drug is extremely dangerous, and I will never prescribe it to anyone. It should be removed from the market!!

Back in July of 2007 I had a partial Colectomy and was given Levaquin before the Surgery. When I woke up from the surgery I immediately felt all types of strange symptoms like, vibrating all over my body, anxiety, chills, Heart palpitations, tremors, insomnia, memory loss, and panic attacks. They told me that it was the anesthesia wearing off so I just sat in bed feeling that way for my entire 2 week stay in the hospital. When I went home these symptoms persisted as well as continued pain in my lower left quadrant where surgery was performed. It has been 8 months now and the symptoms are not getting better. They have conducted MRI’s, MRA’s. EEG’s, EKG’s, CAT Scans, X-Rays, numerous Blood Tests, and Thyroid tests but have found no physical problem. They can see that I’m having the symptoms I describe but cannot give me a reason for them. At first they thought that my Thyroid was having problems that turned up to be inconclusive. The doctors are currently referring me to a third Colorectal Surgeon, a Neurologist and a Second Gastroenterologist. We are also looking for a new Endocrinologist and will be going to the Cleveland Clinic for help. My life has come to a virtual standstill and I have no Diagnosis or direction to go toward other then the possibility that I have been affected by the Levaquin they gave me. I found a website that has all kinds of information concerning Levaquin poisoning. http://www.fluoroquinolones.org

I took 500 mg. Levaquin for 9 days for a sinus infection, beginning 2/20/08. I noticed my hips ached, my lower back (kidneys?) did as well along with chest pressure, insomnia and overall tiredness, which I suspect was associated with the insomnia. I took it at night, so while I noticed dizziness when I was up at night, it didn't affect my day. After speaking with my doctor, I stopped taking the medication, and I won't take it again. Has anyone tried naturopathic or homeopathic remedies to help cure the side effects? I'm tired of the "cure" being worse than the sickness. Thanks.

I was prescribed Levaquin 1000 mg. for 5 days for pneumonia the last week of December 2006. I was also prescribed Prednisone. Everything I ate tasted like metal. A couple of days after I started taking the Levaquin I started experiencing muscle cramps in my rib cage which are so severe it makes me double over in pain. After more than a year I still have the muscle cramps which now include not only my rib cage, but the arch of my feet and sometimes legs. I have a torn tendon in my left arm which didn't happen until about a month ago, but I am sure it is caused from muscle damage from the Levaquin. I am also on Advair Discus 250 which I didn't take before using the Levaquin. I didn't require inhalers or other medication before the pneumonia. My doctor now says I have COPD caused from asthma and chronic bronchitis. I used an Albuterol inhaler when I first got sick because the pneumonia was so bad. I thought after taking the Levaquin I would get back to normal. But even after the infection was cleared up I would get out of breath, so I returned to my doctor. She did an x-ray and said I had COPD and prescribed the inhalant. What I don't understand is that I didn't have breathing problems before the Pneumonia. I didn't have joint pain and muscle cramps either. I have had to quit working this past year because of it. I cannot go without the Advair, I can no longer walk long distances without pain. I have constant muscle pain just trying to do normal housework. How long do the effects last? Must be a lifetime.

I see that the effects are finally hitting the medical community. There have been messages here from nurses, doctors and members of doctors families. Maybe now the word will get out. It's unfortunate that so many people have been forced to suffer while others lined their pockets. Worse yet is the ignorant disciples who expound the virtues of the new wonder drug while refusing to see the damage that is right in front of them.

On another note, my daughter just came down with the flu while at college. She went to the on-campus infirmary and while she was there she told them "no quinolones, my parents will not stand for that". She has seen the damage first hand at home. The doctor and nurse told her not to worry, they would not prescribe them at that facility because they were all to aware of the problems associated with these drugs. Thank god! Intelligent medical professionals do exist.

Concerning the class action suit....if anyone find info, count me in. I can't get my bicep back the way it was nor can I overcome these lingering effects (after 1.5 years) but I'd sure like to see they don't do this to anyone else..... ever again.

I started taking Levaquin in December for a respiratory infection (500mg for 10 days). The only side effects I noticed while taking it was a terrible headache, insomnia and anxiety. I experienced that after the first dose. The next day I called my Dr. to tell him and he said he would prescribe Ativan and I should continue with my prescription. I wish I had listened to my common sense, but I listened to the doctor. I finished the prescription and felt somewhat better from the infection but after 10 days of being off the Levaquin, I started to get a burning pain in my left arm. At first I thought it was a blood clot or something. Two days later, the pain had spread to both arms. The pain was so intense I thought I was going to pass out. I had severe joint and muscle pain. I suspected it was the Levaquin when I found this and other websites where people have been describing their experiences. I made copies of a lot of information to take to the doctor. When I went the doctor I described my pain and tried to show him the information, but he didn't believe me. He said it was not caused by the Levaquin. Since then, the pain has spread to my knees. I have decided to find a new doctor since I refuse to waste my time on a doctor who doesn't even believe me. I called the FDA to file a med watch and they said they were going to send me paperwork..guess what..that was last week and I still haven't gotten paperwork. I believe that everyone is trying to keep this undercover! I am going to go to their website and download my own forms and file.
Two weeks ago I started taking a regimen of vitamins: Daily 3000 mg vitamin C, one B Complex, Milk Thistle, 1000 mg Calcium, 500 mg Magnesium, Potassium, and a Probiotic supplement. I don't know if these have helped me, but I do want to say that I feel better than I felt two weeks ago. I still have a lot of pain, but it's not as severe as it was. I'm hoping that it goes away soon. I am spreading the word among family and friends to NEVER take anything in the quinolinone family of antibiotics. I really don't believe that these side effects are as rare as they say. I just believe many people don't report because most don't connect the dots that their symptoms were caused by the antibiotic. My symptoms didn't start until almost two weeks after I completed the antibiotics. I was just lucky enough to have figured it out. The other symptoms I am having are muscle twitching, trouble focusing, insomnia, and cold hands/feet. I also just once had a ringing in my left ear that made me feel like I lost some of my hearing after it finished. I hope that's not the case. I will continue to pray for all of you.

Hey all. I suspect many of you would agree that one of the most infuriating aspects of this antibiotic nightmare is that seemingly, there aren't many {none that I've dealt with} doctors/nurses or pharmacists that will even acknowledge the potential {and VERY REAL} side effects of these drugs.

On 01/10/08 I was put on Cipro 500mg twice daily, two week supply, for epididymitis, which likely stemmed from a bacterial infection/urinary infection back in late Oct of 07. It's an infection that can require a lengthy dosage due to eliminate bacteria growth. I was also prescribed a painkiller along with it.

That night after dosing had horrible nausea/vomiting, and chalked it up to the painkiller ... which at that point it likely was. Within a few days the groin pain from the infection had subsided a great deal, and although felt a little 'odd' from the Cipro, nothing too noteworthy. At eight days into treatment, became nauseous around the clock with bizarre flu like symptoms. I called the doctor at the ER who had diagnosed me, and she switched me to Doxycilline {sp?}, which isn't a quinolone. After stopping the Cipro, nausea disappeared. However, within a week the pain of the infection returned, apparently due to the weaker antibiotic.

So I was re-checked on 01/24/08 and put on Levaquin, 250gm once daily. Within a day or so the pain subsided once again, but on the third day developed horrible diarrhea and pain in my left knee/leg. Stopped taking it immediately, and decided to research my dilemma online, where to my horror I've discovered all sorts of people from all walks of life experiencing debilitating side effects from this grouping of fluoroquinolone/quinolones antibiotics.

I'm now on Cephalexin, and the pharmacist I spoke with today assured me that it's not part of the quinolone grouping. He also suggested that I must be part of that small pool of the populace that has trouble with quinolone antibiotics ... one begins to wonder just how "small" this pool is given how the average person isn't likely to associate muscle/joint pain with the antibiotic they're ingesting.

How this POISON has lasted so long on the market without more exposure/media coverage speaks volumes about the state of corporate America, with nearly every social system compromised {usually at the expense of the corporation's victims} , with little or no help from the corporate owned mainline media, which serves as nothing but a megaphone platform for vested intertests to transmit "official" opinion to the unwary. So here I be with very painful knee, which I should add is already compromised due to a major tibial plateau fracture in 2001.

I'd love to know whose palms are being greased to keep this rat poison available ... hell, I even had to pay over our insurance co-pay fore the Levaquin, as it's apparently a "top shelf" drug.

Good luck everyone ... and it probably doesn't need to be said, but man, I know after this I will check and double check any and every antibiotic that may be perscribed to our daughter in the future!

I started taking Levaquin last Friday ( the 11th) for a severe sinus infection. I was prescribed 750 mg for 5 days. I finished that but my sinus infection didn't improve so I was prescribed another 5 days of 750 mg. I took the pill yesterday and today ( totally 7 pills) I noticed on about day 2 or 3 that my legs felt tight, but thought it was a normal side effect. Then my lower back. I wasn't in serious pain at all so I ignored it. Today my knees, knuckles, shoulders, elbows, are extremely sore and i get sharp pains every now and then. It also hurts to sit for too long. I started researching the drug and now am so terrified after reading all these horror stories. Has anyone had this only last while taking it and not for months afterwards? Or am I pretty much in this for the long haul. And to the people who say that it lasts for months or years is it pain that disables you from working and doing daily things? I'm only 23 and I live a very active life and I'm totally freaked out now. PLEASE HELP

I was prescribed LEVAQUIN for a sinus infection. This was my first time to hear about or take this. I have had reactions to Keflex in the past. So, within about three hours of taking Levaquin, I had red spots and was manic mad. I felt like some maniac. A few hours later, I had two deep and bright red circles on my stomach. The burning was like a fire and it was actually hot to the touch. My roommate touched it and it felt like fire to them. I stopped the medication and went to see my doctor that Monday. The pain was continuing. The Levaquin Rep just happened to be in the office when I was there. He said, "Yep, happens to about 1 in 10 people" The burning later turned into a black spot, about three inches in diameter. I felt and WAS burned. Also, my bicep muscle hurt and the pain in my shoulder was unbelievable. I've read about all of the other posts about muscle pains. My ortho doctor said I have a torn bicep muscle. Now, I work out but am not a muscle guy by any means. I have two female friend and one went numb from head to toe on exactly one side. The other friend had SEVERE burns all over her body, her skin fell off and hair fell out. She has been fighting side effects inside and out from Levaquin. We both feel that we were burned from the drug. Her case was MUCH more serious than mine. My heart goes out to all of you for your pain and loss. This drug needs exposure.

Struggling with a sinus infection that threatened to bore into my brain, resulting, ultimately, in seizures and death, I've been taking Levaquin now for three days. I'm experiencing anxiety and sleeplessness, however, it's not from the medication. It's from all the hyperbole on the internet.

Look, I understand that many have had adverse reactions to this medication. One dose of penicillin can kill you without warning. At anytime. No warning. I suspect that few of those labellings Levaquin "poison" would ever bother to consider that - or anything else. All wrapped up in your misery, you spout off with rhetoric that is really better left to lawyers and politicians.

If you were uninformed of the possible side-effects of this medication, blame your doctor. I see that the last post here is dated November 2007, and the bottom of this first page takes us to October 2006. Perhaps one could take a bit of responsibility for oneself and do some research on one's own before popping a pill handed out by a disinterested physician. This information is out there - and yes, your doctor could have seen it, too. But he didn't bother, did he? Neither did you.

So, yes, with my first dose, and despite the impact drill driving through my eye-socket, I waited for the seizures, swelling and signs of imminent demise. Nothing. Sorry. Oh, my sinuses feel better, I don't have a brain infection, and so I won't die frothing at the mouth on my living room floor.

I'm sorry you feel bad - and if you hadn't run off at the mouth calling what may be one of the last effective antibiotics "poison", I might mean that with some sincerity. Oh, and lest you forget, antibiotics are poison by definition - the idea being that they affect/poison/kill the source more than they do the host.

So let's stop the hyperbole, and simply say you had a bad reaction to this medication. Not everyone does. Your option might have been to skip the doctor and the meds altogether, and see how you'd fare. But that would leave the responsibility, and the blame, all on you, then, wouldn't it? Far better to spread it around some.

My son is 14 years old and was given two rounds of this drug for an infection (two weeks and one week respectively). Last round in the middle of September. The pain started with the first round and got worse the second time. Real bad. We had him tested for a multitude of diseases and x-rayed the knees - all came back normal. We finally stumbled onto the fact that the joint pain coincided with the drug - WE WERE NEVER WARNED!

Well, he's a heck of an athlete/student/good kid...and has been wrestling since he's 5 years old, has competed nationally and this sport is "his thing." Well, now he's finally in high school and can barely make it through practice - can't go live at all. The pain and stiffness ain't going away even though he's been off it since September!

What in the world can we do to treat this effectively (or t all)? Doctor prescribed anti-inflammatory meds and they did nothing. Physical therapy is doing nothing. Ultrasound treatment on knees is doing nothing.

How long will it last?

Help please anybody with any information - we're disparate.

Prayers are welcome too.

Thanks.

Craig V. (Dustins Dad)

i have been prescribed levaquin many times in the past of my chronic sinusitis, it is not until this past two weeks that i had noticed severe symptoms, pain in feet, ankle, leg, hip and shoulder, making it difficult to walk and or do stairs. i have stopped taking levaquin, for 2 days now, i am hoping my symptoms improve. should the company not put stronger warning labels on this medication? or inform the medical community of the severe adverse reaction so that they can quickly diagnose their patients when they complain of these symptoms

I had acid reflux for about 4 weeks with no relief. My doctor checked my liver, pancreas, and gallbladder and all were fine. She thought perhaps I had an infection so she gave me a 7 day course of Levaquin. I questioned her nurse and the pharmacist if the medication was safe to take or if it had side effects that I should worry about. Both said it was safe and that there were no known "bad" side effects. Both failed to warn me of the dangers of this medication. On the fifth day I noticed a "hives" like rash on both my arms. At the time, I didn't connect them to the Levaquin. After the 7th day (yesterday) I began to wonder if it could be a reaction to the drug. Last night the rash got worse, and this morning I had a very difficult time getting out of bed. I took a Benadryl last night thinking that perhaps I was having an allergic reaction to something I had eaten. This morning when the rash was worse I came on line and did a "Goggle" search on Levaquin and rashes... OMG, how could the doctor and pharmacist not told me about the problems associated with this drug??? They both were totally negligent about warning me about possible side effects. The worse part is that I was trying to be a knowledgeable patient, I asked the right questions and got the wrong answers!

What do I do now and will this rash go away and the pain in my legs go away without permanent damage???

This is a total lack of responsibility from the medical community and the drug company!

#12891. Wrong...guess again. I don't work for a drug company. Let me guess...you also think the Govt is monitoring all your phone conversations, right? My comment was not meant to stir brash comments. I was merely stating that Levaquin has worked very well for me (and others I know). I was actually shocked to see this forum with all of the postings. The idea of "group-think" is not a new one. If I give you a pill and tell you it causes 99 out of 100 people to feel dizzy, I can guarantee you that you'll feel dizzy even if it's a Pez candy. My point was that although this forum may raise some issues, we are not the medical community. Maybe it is a dangerous drug that hasn't been labeled as such yet. Maybe it isn't. I respect that you had negative side-effects, but it doesn't apply to everyone.

Take a gander at the following:
Stomach bleeding, tinitus, hearing loss, confusion, vomiting, diarrhea, liver damage, CNS damage, stoke...and 300-500 deaths per year. The drug ... ASPIRIN.

If you don't trust your Doctor to prescribe a safe drug for you, then change doctors. Getting medical advice from the internet is a very scary concept at best.

"it is your responsibility to ask about potential side effects, interactions with other drugs you are taking, etc. It is also your responsibility to read the detailed informa tion that comes with every prescription from a pharmacy that lists possible side effects"

Excellent advice but with one FATAL flaw. The majority of the information recieved from the physician and/or the pharmacy is wholely inadequate regarding the side effects of these drugs. (the majority of them are not even listed) When asked about the potential side effects the physicians routinely state that these are safe and effective drugs with minimum side effects. Nothing could be further from the truth. The monographs indicate once again that such events are rare and occur at rates approaching 1%. Once again, not true, in reality they rapidly approach 27%. One recent study indicated 65% (Cipro when given for prostatitits) When such events manifest again the medical community denies any and all such assocation stating that they have never heard of such things, even though it has been reported in medical journals for almost forty years. Of the hundreds and hundreds of adrs reported within this forum you will not fnd ONE that is not a known, listed and published adverse event. It has been only through forums such as this that such knowledge is shared. You certainly will not find such information readily available from your physician or from your pharmacist. Herein lies the problem. Nor will you find it within the monographs as such warnings are couched in antiquated descriptions such as uticaria (itching) and other greek and latin terms for common medical conditions. This has been done deliberately to mislead the general public regarding such events. It is not lack of common sense that these victims are lacking, it is the trust that they have placed in their physicians to have an intimate knowledge regarding toxic chemotherapuedic agents that they hand out like Halloween candy. Such ignorance is rampant and to expect a physician who routinely fails to recognize, treat and report such events to be of any value during such a discussion is asking far too much. Patients are routinely handed free samples of these drugs, with no risk vs benefit discussion ever taking place, no monograph or any other information provided by the physician, and then told when such events manifest "..it cannot be the drug.." are instructed to continue taking it. The majority of the medical community has no idea what a fluoroquinolone is and what drugs make up the class let alone what the potential side effects may be. If the lack of common sense is found to be so disturbing then perhaps the lack of common sense regarding the prescribing of these toxic drugs that needs to be addressed. Not the ignorance of the patient who trust the FDA, the manufacturers, the physician and the pharmacist, only to find that thier trust has been grossly misplaced. There are anything BUT a safe and effective antibiotic with minimum side effects. They in fact are not even true antibiotics. They are a toxic and dangerous form of chemotherapuetic agents of last resort. ONLY to be prescribed when nothing else has proven to be effective. They are not and never were intended to be a first line agent. These are one form of such therapy that indeed have the potential to do far more harm than good when carelessly prescribed. Such ignorance cannot possibly be considered the fault of the patient. It is the fault of the prescibing physician. Should one wish to attack the lack of common sense I suggest that they start there. The victims of such scripting abuse have enough problems to deal with without adding such nonsense to thier never ending list.