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FDA Requests Black Box Warning on Cipro and Like Antibiotics

Posted by Chrissie Cole
Wednesday, July 09, 2008 12:58 PM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Dangerous Drugs, Cipro, Antibiotics, Tendinitis, Tendon Rupture


IMAGE SOURCE: Wikimedia Commons/ Cipro 500mg / author: Shorelander

The U.S. Food and Drug Administration (FDA) announced today that the manufacturers of Cipro and other like antibiotics would now include a box warning, also known as a “black box” warning on the products.

According to the FDA, the drugs, which are known as fluroquinolone antimicrobial drugs, increase the risk of tendon rupture and tendonitis in some patients. Other drugs in this class include Levaquin, Avelox, Noroxin, Factive and Floxin.

The black box warning is considered the FDA’s most urgent warning and is intended to highlight the dangerous risks associated with a particular drug. The boxed text is displayed more prominently then the text surrounding it and therefore provides a better safety warning to users.

Drug manufacturers will also have to include a revised medication guide with the antibiotics. The FDA hopes these steps will help strengthen the warning information that is already included on the product labeling for the fluoroquinolone class of systemic antibmicrobial drugs.

In August 2006, Public Citizen, a consumer watchdog group, petitioned the FDA to include a black box warning on fluoroquinolone drugs such as Cipro and to warn doctors. The group filed a lawsuit earlier this year forcing the FDA to take action.

On Tuesday, Public Citizen said, they are pleased with the FDA’s new order, but they still believe there is much more for the FDA to do.

The FDA has been closemouthed about Public Citizen’s request asking the FDA to send warning letters to physicians outlining the potential adverse reactions associated with use such as tendon pain, so that patients could be given alternative medications before tendons rupture, the group said.

When asked about the lawsuit and why the FDA didn’t order the black box warning up until now, Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products, stressed that the FDA included warning information with the drugs from 2001 through 2004 and updated the information last year.

The makers of fluoroquinolone drugs will be expected to submit revised label changes to include the new safety warnings and updated medication guides within 30 days of receiving FDA notification or convey reasons why they believe labeling changes are not deemed necessary.

Fluoroquinolone drugs can increase tendonitis and tendon rupture risk – which is about 1 in 100,000 – by three to four times, according to Dr. Renata Albrecht, MD, of the FDA.

The risk is further increased in those that are 60 years or older, those who’ve undergone heart, kidney and lung transplants, and those taking corticosteroid drugs, said the FDA.

Between November 1997 and December 2007 there have been over 400 reported cases of tendon ruptures and 300 cases of tendonitis in patients using fluoroquinolones, according to Public Citizen.

Only a small fraction of cases are actually reported to the FDA, therefore the true number of tendon injuries and ruptures attributable to fluoroqunolone use is likely much higher.

Due to pending litigation the FDA would not be more specific other than to say they have received “hundreds” of reports of tendon problems linked to fluoroqunolone use. And the FDA continues to receive a substantial amount of reports on tendon adverse effects.

Patients are advised to stop taking fluoroquinolone antibiotics at the first sign of tendon pain and to contact their doctor immediately. #


Anonymous User
Posted by Chambers
Wednesday, July 09, 2008 10:37 PM EST

I took Cipro for Diverticulitis. Afterwards, I have diagnosed tendonitis in my thumb and have appt. to see doctor for sever right should pain.

Anonymous User
Posted by George
Wednesday, July 09, 2008 10:40 PM EST

Have tendonitis after taking Cipro. Diagnosed in thumb and appt for severe should pain to have diagnosis

Posted by david fuller
Thursday, July 10, 2008 10:02 AM EST

"Fluoroquinolone drugs can increase tendonitis and tendon rupture risk – which is about 1 in 100,000 – by three to four times, according to Dr. Renata Albrecht, MD, of the FDA."

Dr. Renata is GROSSLY misinformed regarding this risk and is DELIBERATELY attempting to mislead the treating physician and the patient alike. Continuing in the pattern of the FDA to protect the profits of the drug companies, rather than the well being of the patient. To wit:

Citing to the following studies:

J Heart Lung Transplant. 2008 Jan;27(1):46-51.

Quinolone-related Achilles tendinopathy in heart transplant patients: incidence and risk factors.
Barge-Caballero E, Crespo-Leiro MG, Paniagua-Martín MJ, Muñiz J, Naya C, Bouzas-Mosquera A, Piñón-Esteban P, Marzoa-Rivas R, Pazos-López P, Cursack GC, Cuenca-Castillo JJ, Castro-Beiras A.

"5.8%; 95% confidence interval" (that is 6 out of 100.)
Fluoroquinolones-induced tendinitis and tendon rupture in kidney transplant recipients: 2 cases and a review of the literature.
Muzi F, Gravante G, Tati E, Tati G.
Department of Oncologic Urology, S. Eugenio Hospital, Rome, Italy.
The incidence is 0.14% to 0.4% but, in the kidney recipient population, the phenomenon is even more common (incidence, 12.2%-15.6%). (Here we are looking at .4% or 16 out of a hundred.)
Evidence of tendinitis provoked by fluoroquinolone treatment : a case-control study. Corrao G, Zambon A, Bertu L, Mauri A, Paleari V, Rossi C, Venegoni M.
Unit of Biostatistics and Epidemiology, Department of Statistics, University of Milan-Bicocca, Milan, Italy.
Current use of fluoroquinolones significantly increased the risk of tendon disorders as a whole (odds ratio [OR] = 1.7; 95% CI 1.4, 2.0), tendon rupture (OR = 1.3; 95% CI 1.0, 1.8) and rupture of the Achilles' tendon (OR = 4.1; 95% CI 1.8, 9.6).
Avoiding Achilles tendon ruptures in the elderly - Literature Monitor
Clinician Reviews, Oct, 2003 The odds ratios (ORs) for Achilles tendon rupture were 4.3, 2.4, and 1.4 for current exposure, recent exposure, and past exposure to quinolones, respectively, compared with nonexposure.
A more recent retrospective study [43] reported results that were collected from an outpatient database in The Netherlands. In that study, 1841 patients who had received a fluoroquinolone were compared with 9406 patients who had received another class of antimicrobials (amoxicillin, trimethoprim, trimethoprim-sulfamethoxazole, or nitrofurantoin) to determine the association, incidence, and relative risk of using a fluoroquinolone and developing tendinopathies.
This resulted in incidences of 7.74 cases per 100,000 days for fluoroquinolones or a relative risk of 2.4. Ofloxacin was shown to have a relative risk of 4.9. These risks adjusted to 3.7 for all fluoroquinolones and 10.1 for ofloxacin when the incidence of Achilles tendinopathies was evaluated specifically.
Pharm World Sci. 2001 Jun;23(3):89-92. Related Articles, Links

Fluoroquinolone use and the change in incidence of tendon ruptures in the Netherlands.
van der Linden PD, Nab HW, Simonian S, Stricker BH, Leufkens HG, Herings RM.
Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands. vanderLinden@mi.fgg.eur.nl
The absolute number of hospitalised tendon ruptures increased with 28%, from 768 in 1991 to 984 in 1996. If the total increase of hospitalised non-traumatic tendon ruptures would be attributable to the increase in fluoroquinolone use, this would mean that the risk of non traumatic tendon ruptures to fluoroquinolones would be more than 250 times the risk during non-use.
Expert Opin Drug Saf. 2005 Mar;4(2):299-309. Related Articles, Links

Fluoroquinolones and tendon disorders.
Melhus A.
Lund University, Department of Medical Microbiology, Malmo University Hospital, S-205 02 Malmo, Sweden. asa.melhus@mikrobiol.mas.lu.se
Despite many published case reports and approximately 3500 cases reported to the World Health Organization Collaborating Centre for Drug Monitoring, little is known about the mechanisms behind this fluoroquinolone-specific toxicity.


Fluoroquinolones have been associated with tendon disorders, usually during the first month of treatment,1-5 but the epidemiological evidence is scanty. We did a nested case-control study among users of fluoroquinolones in a large UK general practice database to study the association with Achilles tendon disorders. Our results indicate that this adverse effect is relatively rare, with an overall excess risk of 3.2 cases per 1000 patient years.

Between 1987-1997 the FDA recieved 93 reports of tendon rupture, 103 reports of tendiopathy and 17 reports of tenosynovitis. This data is excluded from Public Citizens petition as all adrs reported prior to 1997 reside on a totally different database.

42 reported tendinopathies in 2000 Finland

130 reported tendon inflammation or rupture (England, France and Belgium, 1996)

921 reported tendon disorders France
340 reported tendonitis, 81 tendon ruptures 1996, WHO

100 reported tendinopathies 1985-1992 France

421 reported tendon disorders and 81 tendon ruptures 1999
Therapie 1996; 51: 419-420 Tendon disorders with fluoroquinolones 421 cases have been collected by the Centre de Pharmacovigilance, 340 of tendinitis and 81 cases of tendon rupture.

Australia. The Adverse Drug Reactions Advisory Committee first reported tendinitis in association with fluoroquinolone antibiotics in 1997. The Committee has continued to monitor this adverse reaction, and has now received 60 reports of tendinitis, tensosynovitis and/or tendon rupture in association with these drugs.
60 reported tendonitis August 1999
Fluoroquinolones tendinitis update Australia
Tendinitis associated with Fluoroquinolone therapy
(Pharmaceuticals Newsletters Nos 7&8 July & August 1997)
ADRAC Bulletin, vol 18, No 3, August 1999
Tendinitis and tendon rupture with

704 achilles tendinitis, 38 ruptures 1992-1998 Netherlands
42 spontaneous reports 1988-1998
Tendon disorders attributed to fluoroquinolones; a study on 42 spontaneous reports in the period 1988-1998
Van Der Linden et al (American College of Rheumatology; Arthritis Care and Research 45; 2001 pages 235-239) June 2001

1847 reported tendinopathies December 2001
Tabelle 7
Pharmacovigilance: Meldungen von Tendinopathien im Vergleich zu allen gemeldeten unerwünschten Arzneimittelwirkungen (UAW), Stand 17. Dezember 2001.


Spontaneous Ruptures of the Achilles Tendon, US Armed Forces, 1998-2001
Methods. The Defense Medical Surveillance System was searched to identify all incident ambulatory visits of active duty servicemembers with a primary diagnosis of non-traumatic rupture of the achilles tendon (ICD-9- CM code 727.67) and other tendon ruptures (ICD-9- CM codes 727.60-727.66, 727.68-727.69) between January 1998 and May 2001.
The most striking finding of this analysis is the sudden and significant increase in rates of achilles tendon ruptures beginning in calendar year 2000. The increase was manifested across all Services and in most demographic subgroups (table 1). Rates
of non-traumatic ruptures of several other tendons also increased during the period; and increases in ruptures of the rotator cuff were comparable to those of the achilles tendon.
(This sudden increase corresponded directly with the addition of levaquin to the formulary. Coincidence? I doubt it)

"Rather than add a boxed warning which is sure to pick up media attention (even if no new data is presented to doctors or patients), the public would be better served by the FDA actually looking into adverse events." One physician had stated on anothr site. And I would have to respond that the FDA has been "studying" this for more than two and one half DECADES. (since 1982) What more is to be gained by further delay? If in twenty six years the physician STILL cannot get it through his or her thick head that this reaction is not "rare" but rather a common adverse reaction that requires careful monitoring of the patient what possible use is further study going to be?

We know the mechanism of action, we know that in most cases it leaves the patient severely injured, we know that the scripting abuse is shamefull, and last but not least we know that the FDA is grossly malfeasant when it comes to drug safety.

Nothing has changed in reality other than "circling" the warning that has been on the label since 1996. Only problem is that the patient is the only one paying any attention to it, and then only after blowing a tendon.

No, further investigation is not clearly warranted. The facts have been established a decade ago. Clear and precise warnings devoid of anything that would trivialize or minimize these reactions, including a black box for the CNS and PNS reactions is what is now required. As well as "Dear Doctor Letters" for the clueless physician who to this day has NO prior knowledge concerning something that has been reported since 1982.

This statement by "Doctor" Renata Albrecht that one 1 out of 100,000 was so grievously in error I was compelled to comment even further. Try anywhere from 1-10 out of a hundred if we were to use the above citations as a guide.

Perhaps 1 out of a 100,000 is being recognized or reported, but that has nothing to do with the reality of the actual risk. I believe it to be
.5% of those being treated with a fluoroquinolone, and this is being ridiculously conservative. 1 out of a 100,000? Please, your killing me here.

Try explaining this to a fourteen year old kid who blew out the ligaments in BOTH knees after being exposed to levaquin. The prognosis for full recovery is questionable. This injury was fully avoidable as the patient complained of severe knee pain and the physician DISMISSED IT out of hand being related to levaquin. He was given this drug TWICE (even after reporting severe knee pain) to treat a fingernail infection. Chances are he is forever crippled now. You can read the full case study on the research site.

Of course the manufacturers claim that there are NO reports of ligament damage in the pediatric population involving levaquin.

In yet another case we have a young girl who will spend the rest of her life in a wheelchair now. Her tendons have been repaired so many times now she is beyond surgical intervention. Given cipro for an ear ache a decade ago. Will never walk again.

These are not side effects but criminal in nature for the manufacturers know full well what their products can do. And yet we fail to see proper warnings. These people are not "rare". Their name is "LEGIONS". Physicians who have a clue is what is rare here.

I would suggest if anyone is going to be reporting on this black box warning that they review the more than 4000 medical journal entries, case reports, newspaper articles, FDA petitions, New Drug Applications, etc., found on LINK that shows the continuing malfeseance of the FDA when it comes to providing proper labels for these toxic chemotherapeutic agents.

Posted by deathby cipro
Friday, July 11, 2008 11:25 AM EST

I have a ‘constellation’ of permanent injuries (adverse reactions) that I developed from a week of taking Cipro in 2006, including tinnitus, hyperacusis, hyperlipidemia, visual distortions, insomnia, chronic fatigue, generalized pain, anxiety and severe depression, peripheral neuropathy, in addition to the muscular and degenerative bone issues. Tendonitis is only a small fraction of the damage done by Cipro. All of the ADR's I sustained are listed on either Cipro or Levaquin PI sheets but with the exception of the neuropathy, no where does it say it can become permanent (irreversible). The first ENT I saw wrote it off to Meniere’s disease, although I have no vertigo, and a doctor at a major hospital said "you don't have Meniere's but I have no idea what it is". At least he was honest. Dozens of other doctors and thousands of dollars of tests later, doctors write it off to depression and anxiety except for the documented degenerative bone loss that shows up on CT scans. No prescription has helped with the insomnia, anxiety or depression and actually makes it worse. No supplement or food makes it better. Eating makes me feel sick. I was a healthy 52 year old before this, but every day only gets worse. Yes, none of these symptoms are fatal, nor will any doctor put me in a hospital for treatment (except for depression, which has been untreatable). The original doctor who prescribed this medicine for me after a 'routine' colonoscopy to prevent infection also can’t explain why I have all these symptoms, and after a perfectly 'ok' colonoscopy I also have severe constipation and all sorts of GI problems after her procedure. Also ADR's listed on the Cipro PI. But no cancer. Yet. The FDA needs a person to read the data - or perhaps the data isn’t getting recorded - but one thing is for sure - if people read blog entries like these, and there are blogs all over the Internet proving these drugs have serious and permanently debilitating ADR's someone should wonder what is going on with these quinolones. Tendons are the tip of the iceberg.

Anonymous User
Posted by Seena Darwish
Saturday, July 12, 2008 9:34 AM EST

I took 3 doses of Levaquin 2 months ago. Ever since then, almost every joint and tendon in my body has been in pain. The joint and tendon pain started AFTER stopping the drug. Other symptoms I've had are neuropathy, anxiety, panic, tremors, blurred vision, tinittus. This drug is DANGEROUS!

Anonymous User
Posted by ~Shells~
Saturday, July 12, 2008 8:50 PM EST

Previously HEALTHY, ACTIVE mom of twin boys...
20 pills of AVELOX and LEVAQUIN (prescribed for sinus infection, 2003) completely altered and interrupted my life and the lives of those I love.

(and more), are TOXIC chemotherapeutic agents commonly prescribed by doctors as "antibiotics".

The BLACK-BOX warning for tendon damage is just the tip of the iceberg!! The ADVERSE-REACTIONS caused by these drugs are NOT mere "side-effects", but the result of damage to DNA, due to the TOXICITY of this class of drug. These severe reactions are often
permanent and disabling.




Anonymous User
Posted by teri
Sunday, July 13, 2008 12:27 PM EST

I think it's great to see more publicity about drug side effects. Many doctors forget that patients have a right to be informed about side effects, or perhaps doctors are not informed of side effects well enough to have intelligent conversations about them with their patients. I had a conversation with my doctor about possible side effects of Levaquin before I took it, and my doctor never mentioned tendon disorders, and convinced me to take the Levaquin since it'd be no problem for me to switch to a different antibiotic if I did have side effects. Or so we both thought.
Luckily my mom came across a publication by Public Citizen that talked about tendon damage by fluoroquinolones when I was 7 days into my 14+day course of Levaquin. I'd been wondering why my achilles were so sore and my calves so rock hard. Four years later with continued tendon and nerve pain, I'm still regretting that initial assumption that side effects go away when I quit ingesting the pills. But if this is what the result of 7 days of Levaquin is like, thank goodness for that article by Public Citizen that kept me from taking 14 days worth of pills. I am a formerly healthy, active 35 year old (31 when I took Levaquin).

Posted by Db Cipro
Tuesday, July 15, 2008 1:51 PM EST

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

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

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

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

Anonymous User
Posted by Ty Taylor
Friday, July 18, 2008 4:31 PM EST

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.

Anonymous User
Posted by Todd
Friday, July 18, 2008 5:50 PM EST

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

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

I have met many other patients suffering from the adverse effects of fluoroquinolones. Many of them reside in my community including 3 physicians and more than twenty patients.

Although these drugs may be life saving in certain infections when less toxic antibiotics may fail, they have been promoted for use as first line treatment for sinusitis, and urinary tract infections, and are often given indiscriminately to unsuspecting patients by uninformed and cavalier physicians for such benign illnesses as the common upper respiratory infection. Unfortunately for many patients they are trading a mild short term medical problem for a serious long term one.


Todd Plumb MD

Posted by Matthew Lake
Friday, July 18, 2008 7:10 PM EST

On my 23rd birthday I started ciproI only took 3 doses of cipro in total before realizing what was happening... I went from being a very healthy 23 year old male who was athletic for over 10 years doing Karate, Yoga, Football, Judo and other sports, I eat an extremely healthy diet, no bad foods at all, and generally take care of myself in everyway possible, I have never drank alcohol and never smoked... I have all the blood tests and other tests to prove how healthy I was. After taking the ciprofloxacin my life completely changed in an instant, for months I had to crawl around my house beacuse of the pain in my achilles tendons. I noticed the side effects approx two hours after taking cipro... however my doctor told me to carry on taking it! (I stopped myself after 3rd dose).

After my very first dose of cipro I had a cascade of symptoms that I never experienced in my life before such as; Bilateral Achilles tendinitis, Tendinitis in both wrists, Chronic insomnia where it would take 5 hours to fall to sleep then I would be waking up every 1 hour and this continued for 4 months. What is interesting is that I have never had insomnia in my life before cipro. I also experienced chronic nightmares, moderate peripheral neuropathy (burning, tingling, numbness), constant body tremors, dry eyes, dry mouth, dry skin, pulsating sensation in my stomach/neck/hands, pulsatile tinnitus, tinnitus (4 noises), muscle pains, joint pains. Eye flashes, blurry vision, eye floaters, static/snow vision, inability to adjust from light to dark (right eye), twitching, dizziness, stiff neck, head pressure, eye pain, ear pain, difficulty swallowing, aspiration, GERD, lack of appetite. I also had massive increase in spider veins, nail ridges, constant wrinkled fingers, nail growh abnormalities... and my skin become thinner around my body (breakdown of collagen?).

It has been 9 months now since I had my reaction and I still cannot function properly because of my tendinitis... about 80% of my symptoms have lessened or have now gone away. I am improving at a very slow and frustating rate. How can I go from being extremely healthy and having just a minor infection to not being able to function and feeling like I had aged 50 years in one night. I have lost thousands of pounds in earnings and have not been able to work consistently since my reaction.

I have seen literally thousands of people in the same position as me, a significant portion of them were healthy and young like me, and now are disabled. How can the true devestation of this class of antibiotics be revealed if things like tendon damage does not show for months after the last dose? I feel the numbers reported are probably very small because people are not associating antibiotic use with tendon problems, and other problems as I mentioned above. From the moment I took the antibiotic I had a cascade of symptoms that never stopped showing up until about 4 months post-cipro. From there I healed from most of it but now have several injuries which are likely to be with me for life, or until medicine can fix them. I just want my life back, and for doctor to prescribe quinolone drugs when only absolutely needed

Anonymous User
Posted by Evan P
Friday, July 18, 2008 11:42 PM EST

I'm a 27 year old male who finished a little over 6 weeks of ciprofloxacin in may of 2008. As I was on the drug I noticed increasing muscle and joint stiffness, dizziness, and neve problems such as eye twitching and icy pains shooting down my leg. I assumed these would abate when I stopped the drug, and continued to take it as the doctor refused to give me another antibiotic and I was desperate to get well. Big mistake.

Within a day of stopping I had shooting pains down my legs, and my joints started hurting and cracking loudly when moved. I had constant muscle spasms, tightness and pain in my arms and legs that left me unable to leave the house for a week. I also developed a constant ringing in my ears for the first time in my life, which has not decreased since. Along with a host of other smaller symptoms.

All of my symptoms are still with me over 2 months since stopping the drug and improvement has been very little. A black box warning should include all the possible debilitating side effects of this class of drug. I really hope a law firm will be tenacious enough to persue a class action lawsuit against the makers of these drugs.

Anonymous User
Posted by Gary Boyles
Saturday, July 19, 2008 12:36 AM EST

The number of side effects and the seriousness of these side effects caused by this class of antibiotics is grossly underrated and under-reported. Tendon damage is only one of the many injuries these drugs inflict on thousands of people each year. The delay in time between taking these drugs and having the adverse reactions present can be what has concealed the high number of reactions. Most Dr’s do not even realize that the tendon, nerve, joint, muscle and CNS injuries that their patients develop after taking Fluoroquinolones is related to this class of antibiotic.

The true number of people affected each year by these antibiotics is astounding and has been well hidden by the manufacturers. There are thousands of people that have been permanently crippled and hundreds of thousands more that have suffered the ADR’s of Fluoroquinolones for months to years.
These ADR’s are not uncommon at all.

I was a normal healthy 51 Y/O male that was prescribed Cipro for a uncomplicated UTI. I was not given a risk vs. benefit warning first by my Dr. When I told him that Cipro had caused severe ADR’s, he refused to file a Medwatch or FDA report as I asked him to. He told me he would no longer treat me and I was asked to leave. I was treated like a criminal because I complained that Cipro had given me bad side effects.

I can only say that this Black Box warning is way overdue and still doesn’t cover many of the other severe and disabling side effects these drugs inflict on otherwise healthy people.

Anonymous User
Posted by Sally Court
Saturday, July 19, 2008 12:51 AM EST

In December 2004 I was prescribed Avelox, a fluoroquinolone antibiotic for a sinus infection and bronchitis.
I immediately became very ill. I couldn't get off the couch. As days went on, I began to get pains throughout my body. Then the fasciliations began and the tremors throughout my abdomen. In the insuing weeks, the tremors moved into my extremities. Then the excruciating, burning pain began.
I ended up in the ER twice, had extensive blood tests, Brain MRI's, Cat Scans, and the list goes on to rule out MS, Lupus, Lyme and a host of other diseases. All came back negative. All this began after ingesting the avelox. There is not a doubt in my mind that Avelox poisoned me; that I suffered Central nervous system damage and peripheral neuropathy. It has been 3 1/2 years since this event and I still suffer peripheral pain and short term memory loss.
The first year was wrought with insomnia, anxiety and pain. I thought my life was over. Thankfully my reaction was not as severe as others who have been poisoned by these antibiotics. Nonetheless, my reaction has changed my life. My memory is forever damaged. My hands are in constant pain. My work is hindered. And I feel like it's taken years off of my life.
In my experience, I found very little support from doctors. One neurologist at a major Ivy League medical school believed me and had seen the damage from fluoroquinolones before. But he confessed that he was at a loss how to treat my conditions other than to just treat the pain with pain killers and the anxiety with ativan.
I want more than anything to prevent anyone else from suffering these horrendous adverse effects. These drugs need more than tendon ruptures mentioned in the Black Box. The Black Box needs to mention the CNS damage and the peripheral nerve pain, the excruciating anxiety, as well as a laundry list of other effects suffered by a multitude of victims like myself.
We need a voice! We need support! And we need to be believed!

Anonymous User
Posted by ciprovictimalso
Saturday, July 19, 2008 1:30 AM EST

My husband is a former Marine. He kept in shape over the years & was in great physical condition in 1998 before taking Cipro. He was in his early 40's at that time and quite strong. Shortly after taking Cipro, his arms & legs started to jerk involuntarily when he would try to rest, tiny sores appeared around his ankles, the bottom left corner of his lip swelled (angioedema), insomnia, vivid nightmares, rectal bleeding, anxiety, panic attacks & other things started to occur. Around a month after taking Cipro, the muscle & joint pain started. It was bad. He thought he was developing rheumatoid arthritis. Not long after that, the severe depression came along with suicidal thoughts & acts. In Jan. 1999, he took a loaded .38 revolver, placed it in his mouth & pulled the trigger. He survived that attempt. The bullet went through his cheek instead of his brain. He started having tendonitis which was extremely rare for him. In 1999, he had his first rupture in the back of his left calf around 11 months after taking Cipro. This was an avulsion because the muscle tore completely loose from where it was attached at the bottom of the calf. In 2000, the quadriceps tendon tore at his right knee. In 2001, a quadriceps muscle tore apart in the center of his right thigh. All these injuries occurred with no warning. None of the doctors knew what caused this. His legs were very damaged at this point and causing him quite a bit of pain. He kept trying to work though, telling me as long as he had two good arms left, he'd make a living for his family. For the next few years the ruptures seemed to have stopped & there were no suicide attempts. He was still suffering from so much pain in his body & all the other things were still going on. In 2004, he took CiproXR. Shortly afterwards most of the previous conditions he was having from the first time he took Cipro got far worse such as the involuntary jerking movements of his arms & legs, rectal bleeding, his lip swelled just like before (this lasted for only a few days each time it occurred), bigger sores with dark centers in patches appeared on his body and all the others things got worse. He started having severe headaches & migraines frequently. The numbness in his legs got worse & started in his hands. Tendonitis cases became more frequent. Around 11 months after taking CiproXR, his triceps ruptured at his right elbow in 2005. Months later his triceps & biceps were damaged in his right arm. Near the end of 2005, another tendon ruptured in his lower left forearm using the amount of pressure a person would use to squeeze a blood pressure bulb. His depression became severe again & suicidal thoughts & acts returned. He became disabled after this. I never thought a medicine could do all this. He had 6 ruptures & no one knew why. This should not have happened to him or anyone else.

Anonymous User
Posted by Carlo
Saturday, July 19, 2008 1:57 AM EST

I took exactly 2500 mg (10 pills of 250 mg) of ciprofloxacin over a period of 5 days in the summer of 2007 .

Because of Cipro I need a wheelchair now.

I've always been a healthy person. I took part in squash, tennis, football and jogging.

After taking the third pill the first signs started. I had joint and muscles pain in my calves and arms. Because it was on saturday I did not call my doctor. I did read the paper in the box of Cipro and it did not say to stop immediately. If I did stop I would have less problems. Damned why don’t they warn us better.

On monday I went to my doctor and he said it was from Cipro but he thought it would not harm to go further. He did not know what to do.

Joint pains
Calves/Achilles Arms Hamstrings Shoulders
Muscle pains
Increased joint stiffness
Dry ears
Dry eyes
Dry mouth and nose
Numbness feeling right foot
Joint popping all over my body
Dry sinus
Ear pain
Red skin after touching it / pressure on it

It is almost a year after taking Cipro.

I cannot walk because of pain in calves and Achilles.
I need a wheelchair out of my home.

Anonymous User
Posted by Kim Bean
Saturday, July 19, 2008 10:18 AM EST

I am a 43-year-old woman. In December of 06, I was prescribed Levaquin and then Avelox. I took them for a total of 17 days. Within 24 hours, I felt like I was in a fog. Within two days, I was awakened from a sound sleep with severe muscle cramps in my thighs. My leg pain was excruciating. I was also experiencing electrical and burning sensations all over. I called my doctor. She didn't tell me to stop taking my antibiotic. I continued to take it, never attributing my pain to an antibiotic. Over the next 6 months, I developed tendonitis in every possible tendon in my body. As a professional pianist and piano teacher, I couldn’t practice the piano for 2 months. I couldn’t teach for a whole month as I could barely hobble around. I couldn't drive a car due to the pain in my calves, thighs and knees for 6 months. I couldn't walk 20 yards without my legs giving out. I couldn't even rest my foot on the floor for more than a minute because of the pressure on my tendons. I had to constantly keep changing my position from sitting, to standing, to lying down. I had muscle twitching all over and severe insomnia for about 5 months. I had terrible night sweats, but could never get warm during the day. I lost 13 pounds within 2 weeks. I spent over $3000.00 on medical tests to rule out everything from Celiac's disease to neuromuscular diseases and Sjogren's syndrome. Of course, you can imagine the anxiety over the thought of having a disease like ALS. Gradually, I began to get better. Nearly 2 years later, I have mostly healed. However, I do continue to get tendonitis if I am not careful. I workout daily, as this seems to help ease the arthritis I now have. However, I have to be very careful to not over do it. I have nerve pain in my shoulder and neck that isn't getting better. My husband, an MD, was ashamed that he didn't recognize the symptoms and stop me from taking the drug. He and I both just want doctors to inform patients and recognize these reactions. If I had only known within the first 24 hours to stop taking the drug, I probably wouldn't have had such a severe reaction. These reactions are anything but rare, just RARELY recognized.

Anonymous User
Posted by Rick Radcliff
Saturday, July 19, 2008 2:13 PM EST

My reaction to avelox started almost three months after I took the drug for a sinus infection, in March, 2005. I did not have the muscloskeletal problems that many have, but I had the vision problems, extreme fatigue, dehydration, brain fog and short term memory loss, neuropathy, and tinnitis. Some of these ADRs stay with me today.

The medical community simply does not acknowledge the danger of fluoroquinolones. In 6 months of going from specialist to specialist, no one could tell me what was wrong with me because nobody is looking for ADRs to drugs in their diagnostic paradigm. And because they’re not, people are being mis-diagnosed.

I feel this is nothing short of a health crisis in this country. These drugs are causing major damage to people and incur great cost to our health care system. In my case, I had probably 30K worth of useless tests. Chronic Fatigue Syndrome and Fibromylgia are possible results of fluoroquinolone ADRs. I know that FQ ADRs mimic arthritis in older people. FQs have been known to cause diabetes. And the list goes on.

Black box warnings should include the FULL SPECTRUM of the ADRs assocoated with these drugs. The FDA is only cutting their losses with this warning in response to a lawsuit by Public Citizen. The FDA should insist on Dear Doctor letters in the USA like there are in Europe. But the FDA is not protecting the citizens of this country; that much is evident.

Anonymous User
Posted by Laura Calderon
Saturday, July 19, 2008 2:52 PM EST

Well, the black box warning about tendon ruptures is a start, BUT there is so much more to warn people about. I was misdiagnosed with a kidney infection and began taking Levaquin (500mg once per day) in September 2006. On the 5th day I had to stop taking the medication due to severe shin pain and Achilles tendon pain. I began to have difficulty walking. Over the next several months new symptoms appeared including severe muscle twitching in my legs and feet, painful aching in legs, heart palpitations (for three weeks I had arrythmias for 3-5 hours every day), severe brain fog, paresthesia in feet, toes, fingers, and face, rash on arms, severe shoulder and hip tendonitis, severe insomnia, body vibrations and dysthesias, chills, depression, dizziness, itchy torso, anxiety, panic attacks, tinnitus, eye twitches, GERD, severe neck and shoulder pain, head pressure, tachycardia, burning soles of feet, anorexia with loss of 17 pounds over 5 months, mood changes, crying jags, popping joints, arthritic like pain in fingers, hip sciatica (diagnosed by Rheumatologist), vertical nail ridges, tender scalp and migrating pain (moving from one area of the body to another), horrible headaches, internal tremors, blurry vision. I had not had any of these symptoms prior to taking Levaquin. I began taking Ativan to sleep and ease the anxiety and became addicted to it for 8 months. I was lucky to be on a sabbatical when the symptoms were the worst, otherwise I would have had to take a leave of absence. I spent so much time being tested by different specialists (referred by the primary care physician) for cancer, MS and other neurological disorders. After 22 months I still have many of these symptoms. Levaquin has brutally altered my quality of life.

Anonymous User
Posted by Rocky
Saturday, July 19, 2008 5:03 PM EST

In January 2008, I was 37 years old, married with 3 kids under six and in reasonable good shape considering I had had a partial elbow replacement in September 2006 from a fall. That took a real downward turn once I went to my doctor for what I thought was a sinus infection. At the visit the doctor without doing any test wrote me a prescription for ciprofloxin, which I had never heard of and definitely never used before. Of course I filled said prescription only to be somewhat surprised when I read in the warning that this was a drug used for anthrax infections. Like a good patient, I started the medication even though its strength concerned me only to have burning pain in my surgically repaired elbow and my achilles tendons at which time I called my doctor per the instructions on the medication warnings. The doctor totally ignored my complaints, saying they had nothing to do with the meds and told me to keep taking the cipro. Once again, I did what my doc suggested only to have increased tendon/muscle pain over the next two days and finally found myself having an anxiety attack after 8 cipro tablets. I stopped the medicine and made an appointment with my doctor. For the two days I had to wait to see my doctor, I was in bed with terrible anxiety, severe muscle/tendon pain/weakness and all sorts of neurological issues like brain fog, neuropathy,and spatial proximity distortion that I had no knowledge of before taking this drug. When I did go to the doctor he acknowledged that cipro could have rare side effects but didnt think my issues were caused by the medication and told me to give it a month to see if everything went away and if not come back and we would start running tests to discover my real problem. I left feeling both betrayed and scared , because my doctor of the last fifteen years had basically disregarded all my issues. So I have struggled for six months by myself trying to fix these side effects. At present I still cannot say I am 100% back to normal again. Each day has been a day to discover what side effect I will have today. One day I will have severe tendon pain/tightness then that will resolve and brain fog will creep up then that resolves only to have burning neuropathy plague me for a few hours or days. The side effects from these drugs are exactly that nothing short of a modern day plague. No one acknowledges they exist and no doctor that I have seen has any idea what to do for them except to ignore them or to blame them on another disease, yet every day I have to deal with them as best I can.

Anonymous User
Posted by Laurie Reylek
Saturday, July 19, 2008 5:57 PM EST

I was a healthy, vibrant and active 27 year-old wife and mother when I was prescribed Cipro on September 25, 2007. I stopped after the third 500 MG pill when a "guardian angel" friend helped me connect the insomnia and severe headache I was experiencing to the Cipro....within 24 hours of discontinuing the Cipro symptoms intensified and multiplied. I experienced severe neuropathy all over my body, tachycardia, insomnia (not one minute of sleep for over two weeks), profuse sweating, inability to stop pacing, psychosis, loss of appetite, metallic taste in my mouth, mouth sores, dizziness, tendon pain, joint pain, extreme weakness in every muscle of my body especially my jaw, high blood sugar readings, inability to focus my vision on objects, eye floaters, and many more. After this acute stage subsided I have since gone on to develop vertigo (bad enough at times that turning over in bed induced vomiting), severe jaw pain, treatment-resistant hypothyroidism, inability to digest food and extreme stomach pain, atonic colon, skin that will not heal, multiple food and chemical sensitivities broken capillaries all over my body/face, weight loss, extreme fatigue, and a disabling skin reaction to any amount of UV light, and I look like a deflated balloon...there are more but my memory has been affected as well. If I had been given adequate risk/benefit warnings regarding taking this drug I would have absolutely opted to take another antibiotic instead. This drug has ruined my life, and robbed my children of their mother and my husband of his wife. There is not one aspect of my life that hasn't been affected by those three Cipro pills taken almost 10 months ago. My brief experience with conventional medicine is officially done....if there is one thing that I am grateful for from going through this experience it has taught me that without exception no pharmaceuticals can be trusted, and I will never put my life and health in the hands of conventional medicine again

Anonymous User
Posted by Lou
Sunday, July 20, 2008 2:00 PM EST

Flouroquinolones antibiotics (Levaquin, Cipro, Avelox) can be very dangerous. It’s imperative to understand the potentially insidious side effects and that research be spent on finding a cure.

I was a healthy 43 year old male. 12 days of Levaquin has changed my life. I had never had a side effect from a medication. This dangerous drug is in a different league.

My side effects from Levaquin include a deep ache in thigh, disabling tendon issues across achilles, groin, elbow, etc. I have tingling, numbness sensations, and muscle twitching. I need crutches now to walk, and some days cannot walk at all. This is my life now because of Levaquin.

While the black box warning issued by the FDA is a start, it doesn’t go nearly far enough in describing the seriousness nor the scope of the side effects.

It’s time to recognize the facts and not rationalize them away. Let’s not have more tragedies.

Anonymous User
Posted by Lynne G
Sunday, July 20, 2008 5:05 PM EST

I had surgery in 2000 to remove a urinary bladder stone caused by a previous unnecessary and unsuccessful surgery for minor stress incontinence. I was given Cipro for weeks prior to the surgery and after. I was told that the inside of my bladder looked like raw hamburger meat. I continued to get UTIs while the bladder surface was healing. I was given Cipro many times over the next 5 years by 3 different physicians. I was 60 or over at the time. I was told by 2 physicians that I needed to be on Cipro for a year. After 5 months in 2005, I stopped taking the drug since I developed severe ear pain. I experienced about 20 side effects, tendon rupture, neuropathy, sensitivity to noises, balance problems, rashes and itching, sun sensitivity, fatigue, vision problems, to name just a few. I'm still disabled and suffering. What in the world will a black box do? This drug needs to be withdrawn from the market.

Anonymous User
Posted by Beebo
Sunday, July 20, 2008 5:11 PM EST

The ADR from a derivative of fluoroquinolones changed my life for ever. From being healthy to suffering from day one with, cardiac, neurological, liver, kidneys, muscles, tendons, muscles, visual and auditory damage, debilitating weakness leading to being bedridden for many months, neuropathic pains, indescribable pains, and more. For those who want info strictly concerning the ADR, visit LINK A well moderated forum to exchange info, tips, and is diverse, and has a chatroom, where we meet every Thursday nights, visit: LINK

Anonymous User
Posted by Namid
Sunday, July 20, 2008 10:17 PM EST

The black box warning about tendon ruptures is a good start, but many more symptoms have to be included like damage to the liver, CNS system, heart… There is no part in the body, which can not be damaged by this drug. It must be underlined that the symptoms do not only last during the treatment but that they can stay for a long time or even forever – in my case since 20 years and there is no end in sight. I only took 1 pill Floxin.

What shocks me is that the doctors, who describe these drugs, are not properly informed by the manufactures about the real toxicity and ADRs of the fluoroquinolones. In addition to this the medical class ignores, if a patient shows up with ADRs and is able to connect it directly with the treatment with this drug.

For me it was a battle every day, because it damaged the blood-brain-barrier, which protects the brain. Now substances can enter and cause big damage similar to stroke or brain tumor. I have the feeling that a mouse is eating up my brain bite by bite and it takes away slowly but steadily many of the normal skills and my personality. In order to protect my brain I have to isolate myself and I have to avoid all exposures.

Anonymous User
Posted by Leslea
Monday, July 21, 2008 8:36 AM EST

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

Anonymous User
Posted by Rose
Monday, July 21, 2008 3:55 PM EST

I was previously a healthy 40 year old with no history of kidney, heart or lung problems . A 10-day prescription of Levaquin 500 mg for pneumonia completely changed my life. I have lived with crippling pain and neuropathy for more than seven months because of this poison. The thing I want to point out is that I had a DELAYED musculoskeletal and neurological reaction. I suspected my symptoms were caused by the drug; but when I began researching side effects of fluoroquinolones, my suspicions were confirmed when I found thousands of others online who were suffering from the same problems I was suffering from. Imagine how many others are suffering who have not connected their pain with the drug because they had a delayed reaction. Doctors: Wake up! These are not rare reactions. I personally know more than 10 people who have had a negative reaction to a fluoroquinolone antibiotic. When patients go to the doctor with these symptoms, doctors don't even think it might be from a drug. Instead, they order thousands of dollars worth of tests that all come back negative. Why doesn't the FDA require doctors to follow their patients for a year after they've been prescribed a FQ? I'm sure the world would be shocked! On the other hand, those of us who have been floxed would not be so surprised to see the vast numbers of people affected.

Anonymous User
Posted by Christine B.
Monday, July 21, 2008 6:43 PM EST

Here I sit over 25 months later from taking 4 750mg pills of Levaquin for a simple sinus infection. Here I sit in much pain with blurry vision. I've been in pain every day since day 3 of Levaquin. I wasn't given any warnings, just samples in my doctor's office, who, had been lied to by the drug reps about these fluoroquinolone drugs. I asked, "anything I need to know, any side effects"? "No" I was told, "these are great big-gun antibiotics". No, I have not had a tendon rupture but still have tendonitis in many parts of my body, my shoulder being so bad that my therapist is scared to work on it. My neck froze up 2 weeks ago leaving me screaming in pain and unable to drive. I suffered from severe insomnia, depression and thoughts of suicide, all drug related. I still suffer from many other ADRs including muscle twitching, nerve pain, osteoarthritis (never had this before Levaquin), floaters, gastro problems, liver problems, fuzzy vision, etc., etc., etc. My doctor has written "Levaquin toxicity" as my diagnosis. My neurologist agrees. This Black Box Warning is not strong enough! Tendon ruptures in people over 60 is just the tip of the iceburg! I was only 47 and very healthy when I took this drug. I did not take it with steriods. This drug has ruined my life! It has taken 2 years from me and God knows how many more it will take. These drugs should only be used as a last resort! Please stop hurting people!

Anonymous User
Posted by delphine herbert
Tuesday, July 22, 2008 7:35 PM EST

Cipro , Levaquin and my shattered left ankle -thanks Public Citizen, CNN and Google

My left ankle shattered about 10 a.m. Saturday, April 5, 2008. I have no memory of the event.

I last remember sitting back in bed to finish the newspaper. During the period I cannot recall, I apparently was able to function despite what must have been intense pain as my husband found me screaming on my bedroom floor. Upon becoming aware of my circumstances about two hours later in the ER with my left foot extended in an unnatural position, I asked to speak with my husband. The attending nurse said I had already done so three times and neighbors later reported that I had spoken to them as the ambulance took me away. I had no difficulty recalling telephone numbers during and following my black out.

After an x-ray, CT scan and MRI of my brain along with a cursory interview with a neurologist, the surgeon put a plate and a couple of screws in my left ankle the next day. Following my hospitalization and several weeks at the rehab center, I insisted on seeing another neurologist in an effort to determine just what precipitated this event. The second neurologist did an exhaustive interview (with my husband present) and ordered a carotid artery examination and an EEG of my brain. Again, nothing abnormal was found.

On July 9, 2008 I heard Dr. Sanjay Gupta report on the links between Cipro and broken tendons the day after the FDA issued its “black box warning.” Public Citizen had requested such a warning in August 2006 and Dr. Gupta said on his broadcast that doctors have known about the dangers of the drug since 1992. The FDA approved Cipro for use in 2000 and Levaquin in 1996. None of the doctors who’ve seen me have mentioned, suggested or even implied any causal possibility between use of Cipro and/or Levaquin and the injury I endured. Moreover, after googling the drugs and ankle injuries, I found that there are literally hundreds of personal reports of injury similar to that which I have.

Despite a predisposition to avoid unnecessary drugs, I had not earlier connected repeated use of Cipro and more recently Levaquin to my accident. I simply ascribed the following to stress as a caregiver for an extended period.

Before my Father died May 1, 2005, I experienced difficulty stepping out of bed because of pain on the bottom of my left foot. I could not even go to the bathroom without wearing shoes. . More recently I have had trouble standing for any length of time and walking my dog. I also have felt faint at various meetings and luncheons. . Occasionally the pain on the bottom of my left foot upon getting out of bed recurred. I simply chalked up these episodes to my exhaustion in caring for a disabled husband who is unable to contribute much to running the household and to my activities in the community. Fatigue has been a constant in my life for many years along with shortness of breath and general lassitude.

During recent years I have taken Cipro fairly frequently for recurring urinary tract infections. Last November when an infection did not respond to Cipro my internist sent me to a(n) urologist, who prescribed Levaquin.. Because the infection had persisted and I wanted to rid myself of it, I took the Levaquin DESPITE the fact that I experienced considerably more severe pain on the bottom of my left foot than I ever had before. Since the doctor gave me a prescription with 12 renewals (?) I took Levaquin again when a UT infection recurred yet again in February, I believe.

In the months just prior to my accident I also experienced several very brief transient surges in my brain like flashes of electrical charges – basically the left rear quadrant as I recall. Then on about a week or ten days before the accident I had an earache on the left side which later extended into my left jaw . I’ve had good dental care and the only thing wrong with my mouth is that a crown has fallen off a tooth. But my husband, a disabled dentist, said there was no cause for concern as it could not be a source of infection since it had a root canal. Nevertheless I went to see a dentist, on March 27, who, after taking new x-rays, concurred with my husband’s assessment. . However he said that if the pain continued he would send me to a neurologist in case I had trigeminal neuralgia. I was first to return about ten days later. After reading about trigeminal neuralgia online and because the pain had subsided, I knew I had not experienced this disorder. The accident occurred before I was able to return to the dentist.

Please note that I was again taking Levaquin for the recurring urinary tract infection.. . When I got to the rehab center the attending physician put me back on Cipro because he said that it was the standard for UT.

I’ve since had much outpatient therapy but still am not able to walk well and the foot/ankle remains in large part immobile ( like concrete as one therapist observed), swollen with scarring and a protrusion on the right side where the screws were inserted. Surgeon who I see again next week opined that injuries such as mine take 9 months to a year for recovery although he acknowledged that the ankle will not ever be entirely normal. My surgeon and the therapists said that any injury to the foot is the most difficult to recover from (worse than hip, pelvic fractures) because the foot bears the weight of the entire body.

Although I am now 72 years of age, my parents were long-lived. They both walked every day with my Father even mowing the lawn up north until he was 98. My Father died totally competent just three weeks short of 100 and my Mother died at age 91 of breast cancer which had metastasized. Thus I have expectations of living another 20 years or so, especially given the fact that I have always been well fed, have always had good medical attention and have never indulged in personal excesses of any kind. Our internist since September of 2000 has always authorized routine checkups and appropriate tests for whatever ailment I may have had over these years including a bone density test just months before the accident.
I have learned that there is an array of drugs which were used effectively for urinary tract infections before Cipro and Levaquin were put on the market. Apart from the pain and disruption to both my husband and my lives and the psychic and financial costs involved thus far, I am most appalled at the prospect of circumscribed use of my legs for the rest of my life . I hobble around the house, I can’t garden as I used to and my golden retriever breaks my heart by bringing me her leash for a walk.
I suddenly am old.

Posted by david fuller
Tuesday, July 22, 2008 11:03 PM EST

Public Citizen had requested such a warning in August 2006 and Dr. Gupta said on his broadcast that doctors have known about the dangers of the drug since 1992.

Just to clarify, Dr. Gupta is misinformed. The FDA has known about these reactions since the mid sixties. They were first associated with Nalidixic Acid, which the fluoroquinolone class is derived from, back in 1962. As to the quinolones specifically this became known in 1982, ten years earlier than what Dr. Gupta had stated.

The FDA approved Cipro for use in 2000 and Levaquin in 1996.

Again to clarify, cipro was approved October 22, 1987, NOT in 2000. Levaquin was approved December 20, 1996, which would be correct except for the fact that levaquin is nothing more than a 'mirror image' of floxin which was approved again in the early eighties.

As such we are discussing drugs that were first approved in the early eighties, to which the FDA had been fully informed regarding the risk of spontaneous tendon rupture being associated with their use, for over two and one half decades now.

This is hardly something new by any means. Not one year since 1982 has gone by without something being published in the leading medical journals regarding this. In fact the numbers being cited by Public Citizen fail to even take into account the reports made to the FDA from 1982-1996, fourteen years worth, as they reside on a totally different database than the one being used today. A fact that is conveniently being ignored by the FDA as well as the media; who seemed to forget how to go about doing any fact checking before publishing a story.

Posted by david fuller
Thursday, July 24, 2008 11:06 PM EST

Though I had posted this on other sites dealing with this issue, it is still relevant to the discussion at hand and I would hope the host of this site would not take offense at me repeating it here:
In addition to the recent "Black Box Warnings" as well as the European "Dear Doctor" issued by Bayer overseas back in February 2008 concerning Avelox, the European Medicines Agency has moved to severely restrict the use of Avelox (moxifloxacin), to wit:
FRANKFURT, July 24 (Reuters) - The European Medicines Agency has recommended limiting the use of oral moxifloxacin-containing medicines after finalizing a review of the safety of the antibiotics, the agency said on Thursday.
The European body (EMEA) said it had concluded that these drugs should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.
"The agency also recommended strengthening the warnings for oral moxifloxacin medicines," it said in a statement.
Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer (BAYG.DE: Quote, Profile, Research) under its brand Avelox.
At its July 2008 meeting, the agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of oral moxifloxacin medicines continued to outweigh its risks.
However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, it recommended restricting their use in these indications.
The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.
Responding to the recommendation, Bayer said the review confirmed the positive benefit-risk profile of the drug.
"We would welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care," said Kemal Malik, a member of Bayer HealthCare executive committee and chief medical officer.
Black Box Warnings, Dear Doctor Letters, restrictions place on the use of Avelox, thousands of patients responding to these articles claiming severe injuries from this class, hundreds if not thousands of adverse drug reaction forums with tens of thousands of members world wide, as well as more than fifty percent of these drugs removed from clinical practice, and last but not least the fact that Nalidixic Acid, upon which all these drugs are based is a listed cancer causing agent, I dare to ask: are we still to believe the following comment which can be found at the end of just about any article written about this class?
'The fluoroquinolones as a class are generally well tolerated; most adverse effects are mild in severity, self-limited, and rarely result in treatment discontinuation...'
Or are we to continue wonder if we are the only ones who have bothered to do any research on this class in the past twenty six years. For surely who ever would make such a claim has not.
“Repeat a lie a thousand times and it becomes the truth ...” - usually credited to Dr Joseph Goebbels, Propaganda Minister of the Third Reich. I now credit it to those medical researchers who continue to state how safe and effective this class of chemotherapuetic agents are. For they have repeated this lie a thousand times a thousand times. Rather odd coincident that they are both (Goebbels, and these medical researchers who state such blatant lies) members of the medical community.

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