Tendon rupture symptoms and conditions

I have posted here before when suffering the severe leg pain. I took pain meds for 2 months and it seemed to have subsided. Then, 10 days ago, right beneath my achilles tendon pain, on the side of my foot, under my ankle bone., started giving me severe pain. I could not understand what happened, it hurt as if it was bruised. When I looked at the area hurting me, there was no bruising but was swollen so badly I looked like I had a baseball under my skin! I am having difficulty walking now. I have an awful feeling that I may have a ruptured tendon! I am seeing an orthopedist on Monday afternoon. Has anyone here had a tendon rupture? How would you describe it to be? I'd appreciate if anyone with experience like my own would email me asap!!!

I was put on Levoquin after 4 days of Bronchitis. My body was not responding to the antibiotic so they added Prednisone. I continued on both medications IV for 8 days. After the second day, I developed a severe pain in my groin. I mentioned it to the NP treating me and she said, "we will worry about that once we get the Bronchitis under control". The pain continued as the medication continued. After the Bronchitis was resolved, the pain in my groin was terrible. My doctor sent me for CT scans and and MRI. The next thing I knew I was in the Orthopedic Surgeon's Office talking to him about a total hip replacement. He said the test showed very mild degeneration and he was not sure a total hip replacement for me was the answer. I opted not to have the hip replacement. Diagnostic Testing continued. Finally, my doctor told me that the combination of Levoquin and Prednisone caused a tendon rupture in my groin. He said it would heal but would take a long time. It is now 8 months since I took those medications and my hip is more painful now than ever. I am on pain medication and it does not help. I see my doctor today and we will discuss other options to relieve this awful pain. I walk with a cane and I feel like I will never walk normally again. It has totally disrupted the activities of my life. My doctor tells me to stay off my feet as much as possible to rest the tendon, this is impossible as I am a registered nurse and I am on my feet constantly. This has destroyed my life!

Numerous side effects including but not limited to: spontaneous tendon rupture (right distal bicep), CNS agitation accompanied by anxiety and panic, extreme fatigue, digestive problems, on-going fluctuations of blood sugar level, rapid changes in body temperature, nausea, etc.

Some here insist on reporting the "good" this stuff has done (other than lining some peoples pockets with profits). I disagree. As I post this I see 2250 adverse effects have been posted previously. I urge yo all to look deeper ask the question: "Why so many problems with this class of drug?" The 2250 number is only for Levaquin..... don't forget to add in all the responses for all of the other drugs in the quinolone family. And while you are at it, find out how many other drugs have death as a side effect and how many have been reported. This is a defective drug.

I went in on a Monday for some ear/throat pain, and was diagnosed with sinusitis and prescribed Avalox 400MG. By Thursday, I had an unrelenting headache, SEVERE anxiety and tremors, and decided to Google "avelox side effects". It's Friday morning, and I'm blown away by the amount of negative feedback this drug is getting. Obviously I've stopped taking it.

Worst part? I called my Dr on Thursday morning, told the receptionist that I was having side effects.....NEVER HEARD BACK FROM HIM. And this goddamn drug has a black box warning from the FDA about severe risk or tendon rupture, etc. I f*cking hate Western medicine.

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.

I was a healthy 42 year old male who took Levaquin for a sinus infection. The same day as the Black Box Warning was issued; I was having my third tendon reattachment surgery. I have to wait at least 6 weeks before I can undergo yet a fourth tendon rupture reattachment. At least it takes my mind of the Achilles Tendinopathy, joint pains, headaches, uncontrolled muscle twitching etc. I consider myself one of the lucky ones since so far it has not affected my kidneys, liver, heart, eyes and other side effects that many are dealing with from this class of drugs. I would urge a real journalist to take the time and look at the real number of cases. The Fda numbers are misleading. The clinical data coming from other counties are showing much higher rates of tendon ruptures and other life threatening side effects.

I took Cipro many times but in November I took it with a prednisone dose pack, this seems to make the tendon issue worse according to todays report.

I have had severe achiles tendon pain for 7 months now. I can't bend my ankle when I walk. I also had surgery for a torn rotator cuff in December, no injury to my shoulder, it just tore.

I have wide spread tendinitis an now I know why. Is this a temporary situation? I hope!!!
ksquared

I was given the Zpak several times for infections, approximately 5 or 6 years ago and now suffer from tendon rupture a few year back. Yes, the Achilles tendon, which pinged to a lot of other troubles in my body that I now have to live with.

Saw this story on CNN today. Guess we aren't all tinfoil-hat wearing nutcases after all.

******

FDA orders 'black box' label on some antibiotics

The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendinitis.
Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.

The consumer group Public Citizen asked the FDA in August 2006 to put the "black box" warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.

When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.

"There has been ongoing work to update the labeling of the fluoroquinolone drug products," Cox said. "We have been working on this issue and making progress over time."

The companies that make the fluoroquinolone drugs will be required to submit label safety changes and the medication guide within 30 days of receiving the notification from the FDA or provide a reason why they do not believe such labeling changes are necessary, Cox said.

The fluoroquinolones drugs can increase the risk of tendinitis and tendon rupture -- which is about 1 in 100,000 -- by three to four times, according to the FDA's Dr. Renata Albrecht.

"This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," the FDA said in a statement.

Albrecht said that sometimes patients have no symptoms before they experience a rupture in their tendon -- commonly their Achilles tendon.

"Sometimes it's been reported on the first day of taking a fluoroquinolone ... a sudden snap or popping sound that is tendon rupture with no preceding warning," she said.

Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."

The FDA would only say that it has received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Patients should stop taking fluoroquinolone antibiotics at the first sign of tendon pain, avoid exercise and contact their doctor, the FDA said.

Cox said the FDA would not require companies to send letters to doctors alerting them about the connection between tendon problems and the antibiotics.

"It is possible under REMS to ask for a letter ," Cox said. "Certainly for sponsors that would choose to go forward with a letter, we'll be happy to work with them."

Most of the "side effects" are die off responses (sometimes referred to as a herxheimer response similar to that which occurs when treating syphillis) from bartonella or borrelia. Levaquin is a potent intracellular antibiotic...where these and other organisms can hide. These can be subclinical infections where (at this time) you are not even aware you are infected. If your "side effects" start around the 3rd day into your prescription...rejoice...and suffer for a while, you are killing something really bad.

I took 500 mg. of Levaquin for 10 days in January and caused extreme swelling and pain in both my knees, which I am still suffering from. I've had x-rays and an MRI of my left knee, which shows tearing of the tendons. I had my knee drained and injected and while it's a little better, the pain and swelling is still affecting my lifestyle, to where it's very difficult for me to walk stairs, and has affected my exercise routine as well.
Has anyone thought of filing a class action lawsuit against the manufacturer of this poison? I have filed a Medwatch report with the FDA and called the manufacturer of the medication. They offered to refund the cost of the medication if I sent in the receipt, as well as possibly refunding the costs of the procedures associated with this.

Crapshot, thanks for the info on your thoughts. But in my case as well as others I do not believe this is at all related to Candidiasis. If you scroll down and read my post you will see that I have snapped two biceps from Levaquin. This in not the first time I was Floxed But the other times I was on lower doses and the symptoms didn't appear until well after I had finished my prescriptions. Not only did I have to have 2 surgeries but I was also having heart palpations and severe joint pain that went away after months of my body cleansing itself. This time I figured it out because they put me on a higher dose for a longer period. This time around the symptoms started before I finished my course. I quit taking the Leva-pak and googled the side effects. And they were spot on. Not only do I take probiotics and vitamins daily but I work out and do cardio 4 to 5 times a week, and eat a healthy diet. At the ripe ol age of 41 the doctors were amazed that I have torn each bicep tendon from the bone in a 2 year time period. I AM blaming the pill. Also Public Citizen along with the Attorney General from Illinois is suing the FDA to get this Black Boxed. They are also suing the FDA because they haven't been updating the newer cases of tendon ruptures. It's easy to blame the consumer, but do you think I would have taken this after my history with this medication. If they had the proper warnings and black boxed the tendon rupture I wouldn't have even allowed this drug to be in my house. I'm glad you didn't come away with the serious side effects but please don't blame the patients.

I have taken Levaquin 500 mg daily for the last 7 days. I am quitting it today! I am so tired. Cannot sleep! Have severe pain in both of my hips! I do not have a history of sleep disorder or hip pain!!! I even have severe pain in both of my shoulders now as well. My doctors insist this isn't from the med. My pharmacist differs in that opinion!! This stuff is POISON!!!
I am a registered nurse and will preach this to any and everyone who will listen!!!
I only pray I will not suffer a tendon rupture even after I have stopped this med! If that happens I will contact an attorney! Can we get a class-action lawsuit for all of us and to prevent others from this terrible experience???

One again I see someone talking about the wonders of Levaquin and I can only wonder about the relationship connection to the drug companies and/or the medical profession. Also, the self proclaimed authority on the drug is not consistent with someone who was just given a prescription. Something just doesn't add up. READ the problems that are occurring. These are not the result of no drinking enough water (or any fluid) or from exercising while taking the medication. In fact, my tendon rupture occurred after the POISONING by the Levaquin had ended. No amount of cover-up can hide what the drug companies have done here. Yes, I am angry. Please stopping lying to people about this "wonder drug". It is poison.

I took Levaquin for 5 days (500mg). By the end of that time I was having
extreme joint and muscle pain. Diagnosed for Pneumonia while I was
out of state over holidays. Upon going to my home doctor she immediately
knew this was the Levaquin and after 10 days of prescribed steroids I seem to be past this. THERE WAS NOTHING IN MY DRUG BOOK OR
IN THE INFO AT THE DRUGSTORE THAT ALERTED ME TO THIS SIDE
EFFECT. Please be aware of this. Also stomach bloat and pains.

I went back to my PCP today. Yes the one that gave me the Levaquin. He was very nice and even agreed it was the Levaquin I took back in December. He said that these types of side effects we all are describing are RARE (I would have kicked him for all of us, but my legs hurt to bad).

But he did acknowledge pain and my symptoms (listed in my December post) and prescribed me Prednisone for my ligaments and Lyrica for my nerve pain. He also said it was going to be a long haul. I know that some of you are dying to telling why these meds are bad too, but I am going to try it because I haven't really been out of my bed for two weeks.

I just wanted to let you all know, that maybe some doctors are starting to listen... and that we should keep speaking out and warning others about the HIGH risk of our side effects.

BEWARE OF TENDON RUPTURE DUE TO BACTRIM / LEVAQUIN
I had a UTI that was resistant to Bactrim. After ten days of Bactrim I was put on ten days of Levaquin. Ended up with white blotches (I am dark-
skinned) all over my body. But that's not all. Then my Achilles tendons nearly burst. Horrible pains I couldn't imagine how it was caused. Come to find out that both Bactrim and Levaquin have tendon rupture as a side-effect (never heard it from the doctor or pharmacist though). Since I was on both for a total of twenty days... I suppose I was fair game. Medicine is often a good thing for many who could not reduce or alleviate their ailments without it -- but I would have really liked to have known my increased risk of tendon rupture BEFORE the fact. The odds are probably quite remote for anyone to experience tendon rupture when taking these antibiotics, but were elevated in my case due to the immediate back-to-back, double-dose of Bactrim and levaquin. I hope this posting can prevent my experience from happening to someone else.

I first took avelox last december for cellulitis. I also took levoquin for the same condition. I had a recurrence and took Avelox again this week. On the 3rd day I noticed brief "sticking" pains that would come and go. It felt like someone was poking me, first on the leg, then my back, then an arm. They lasted briefly, and then came back a few hours later. About the same time I noticed my shoulder was hurting, and my forearm and some of my fingers. I thought the infection was spreading and I went back to the doctor, who offered to Xray my shoulder. That seemed pointless, so I said forget it and refered to the package insert, where i found tendon rupture as a side effect. I searched more and found that Avelox, and other quinolones are TOXIC to the TENDONS and may cause muscle and tendon pain. I discontinued the medicine and now am using ceflex to treat the infection. I will wait a while for the pains to resolve, and pray I do not blow a tendon, esp. in my shoulder. I am pretty pissed that the doctor was unaware of this side effect, and when I informed him of my experience he said he would not use Avelox for cellulitis in the future.
KB

My Dr. gave me levaquin July 5th, for a cough that had lasted 3 1/2 weeks. I took the first dose same day. Started having muscle pains in my legs next day, but continued the medicine because I thought I needed it to get rid of my cough. The pains continued to get worse; I couldn't staighten out my legs or put my full weight on them. I stopped the Levaquin after the 6th day. The pain continued for the next 9 days, after which it finally started to lessen. It is now 2 weeks since I stopped taking the medicine, and I still have some pain in my legs, although I can straighten them out and put my weight on them now. I would not take this medication again unless it was the only way to keep me from dying. I am 75 years old, but have not had any pain in my legs prior to this. Funny thing is that my chronic back pain did not bother me during this time.

I took this drug for a kidney infection and now can hardly walk or sit on the toilet. The pain in my knees is excruciating especially at night. I can not turn over in bed without pain and they don"t seem to bend anymore. My doctor thinks I am nuts.I have not slept an entire night since this started. It came on all of a sudden after two weeks on this crap. Please, somebody tell me this is going to go away in a while!!!Marsh

Who would think an antibiotic would have such effects? I have been experienceing pain in my shoulder for about 3 weeks. This began less than 2 weeks after taking Levaquin for 2 weeks. In addition to that, I experienced side effects during the treatment. This include chest pressure and rapid heartbeat.

Yesterday, I saw an orthpaedist who diagnosed me with a rotator cuff injury.
I have one month of physical therapy to endure 3x per week now. If the pain doesn't improve in 2 weeks, then an MRI will be done. If it is ruptured, there will likely be surgery.

I am a healthy 35 year old woman with no history of shoulder problems. The doctor and others have asked what did I do to hurt myself. My answer is that I made the mistake of taking a drug that shouldn't be on the market. I don't lift weights and I didn't pitch 9 innings before this. So the only connection is a drug whose website states "ruptures of the shoulder, hands, and Achilles tendons have been reported...".

I have woarned all of my friends and co-workers about this drug. I am now on a crusade to prevent others from falling victim to this drug. I understand that the risks to the few outwiegh the rewards to many. However, when you are one of the few who is affected, your viewpoint changes. I am an educated woman and did read the side affects prior to taking the drug. I knew this was a possibility but it was "rare". Who knew an antibiotic could be so helpful and harmful at the same time!

was given Levaquin for ear infection to take 10 days about half way thru taking I began to have aching or sore joints. Thought it was from over exercising but didn't go away .Legs began to hurt and knees swelled Have been treated for this with steroid pk and 10 days of antiinflamitory med which has not helped. I have stiffness and pain in my hips and legs and elbows. This has been going on for a month. Have seen dr 3 times .

I forgot to add that by Day 13 I was incredibly weak and in so much pain that I could barely walk which was why I was in tears.

I also remember that the research at that time indicated that you were susceptible to tendon rupture up to 6 months AFTER taking the drug and to be careful not to do any sudden movements, etc.

Susan

I took Cipro in April 2002 with no apparent side effects at the time. In June 2002, I experienced an unexplained tendon rupture in my arm. Over the next year I began to have more and more muscle and tendon pain. Now, February 2004, I have been diagnosed with fibromyalgia. My rheumatologist believes it could be related to muscle and tendon damage caused by the Cipro.