FDA To Seek Black-Box Warning on Cipro and Levaquin

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Posted by Jeff RasanskyJuly 09, 2008 2:41 PM

The FDA has announced that it will be seeking to add black box warning to Cipro and Levaquin. Both are antibiotics that are used to treat bacterial infections. Apparently, each carries a risk of tendon rupture that needs to be addressed. Six months ago, the consumer group Public Citizen sued the FDA to require it to add the warnings to the drug packaging.

Reports of tendonitis and tendon rupture have been on the rise with the use of these drugs, which has prompted the FDA to ask drug companies to add the stronger labeling. Ruptures that have been associated to these drugs include Achilles tendon, shoulder, hand, biceps and thumbs. This risk is especially increased in older patients and those who have received organ transplants.

The FDA believes that the addition of this warning will strengthen the existing warning information already included in the prescribing information.

Other side effects of taking these medications include “seizures, hallucinations, depression, heart rhythm changes and intestine infection with diarrhea.”

The FDA also suggests that physicians “advise patients, at the first sign of tendon pain, swelling or inflammation—symptoms that typically precede tendon rupture and tendonitis—to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.”

26 Comments

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david t fuller
Posted by david t fuller
July 10, 2008 9:50 PM

The advice to 'stop taking the drug' is pointless. Once the patient experiences tendon pain the damage had already been done. This is as frivolous and futile as shutting the barn door after the horses have run off. Spontaneous tendon ruptures is the least of the patients concerns. The safety profile of this class is horrendous. More than half of these drugs have been removed from clinical use due to killing and crippling to many patients. Irreversible peripheral nueropathy, SJS and TENS, fatal liver damage, heart attacks, fatal hyper and hypoglycemia, disfiquring rashes, the list is endless. Those who have an interest in reviewing the more than 4000 medical journal entries (since 1982) that document the true safety profile of these drugs are invited to log unto More ...

This latest change is but a 'slap in the face' to those of us who have been crippled for life by these drugs. It is nothing more than the drawing of a 'box' around grossly inadequate warnings that have been in place since 1996. And we would not even be seeing this if Public Citizen had not sued the FDA for failing to respond to three seperate petitions, the first being filed in 1996, 2005 and 2006 regarding this issue, as required by law.

This is nothing more than a blatant attempt to circumvent the full disclosure that will be required when they lose in court. With the current caselaw, they surely will. This is far too little, far too late as the FDA was fully informed on this risk as far back as 1982 and for the past two and one half decades have done NOTHING of any value regarding providing adequate warnings.

The have also grossly misrepresented the risk factor as well stating it to be 1 in 100,000. You will find medical citations published in the leading medical journals since 1982 (26 years worth) that states this to be anywhere from .5% to 16% depending upon the source and the year it was published. One in a hundred is NOT one in one hundred thousand as they are claiming.

Robert Ouimet
Posted by Robert Ouimet
July 11, 2008 10:24 AM

My wife, Linda, took Levaquin last night for a UTI and suffered heart palatations and soreness of the hands and legs for 12 hours. This was after discussing the dangers of Cipro with her doctor and without knowing the parallel dangers of Levaquin. Where is the FDA?

Seena Darwish
Posted by Seena Darwish
July 12, 2008 9:29 AM

I took 3 doses of Levaquin two months ago and I am still suffering the consequences. The joint and tendon pain started AFTER I stopped the drug. ALmost every tendon and joint has been in constant pain for the past 2 months. I also experienced anxiety, panic, insomnia, and neuropathy. I am 34 yrs old with no previous joint or tendon problems. This drug is DANGEROUS!

Elizabeth
Posted by Elizabeth
July 12, 2008 2:54 PM

I took Levaquin in October of 2006. I did not have tendon ruptures, but I did have joint and muscle pain and weakness. In December of 2006 I seperated my cervical spine from my cranium just from stretching one morning.

I had a plethora of other symptoms, some of which left me bedridden for 4 1/2 months. I had anxiety, sleep problems, nerve attacks with which I would twitch, jerk, and yell out uncontrollably. I had orthostatic hypotension, palpitations, severe digestive problems, my endcocrine system got hit, spawning all sorts of problems like hypothyroid, hyperthyroid, hyperglycemia, hypoglycemia. (I had problems with these things before, but the Levaquin made them much worse.) I lost quite a bit of hair, suffered depression, and the list goes on.

This class of drugs is poison and nothing but. I am glad for the black box warning, for whatever reason the wretched FDA decided to call for it. I am given to understand that when a drug is ‘black-boxed’ doctors are far more likely to NOT prescribe it. I certainly hope this is true.

E.

Shells
Posted by Shells
July 12, 2008 8:28 PM

Black-Box Warning for tendon damage?? What a joke!! Fluoroquinolones such as CIPRO, LEVAQUIN, AVELOX (and more) cause SEVERE, often PERMANENT and DISABLING damage not only to the tendons, but also muscles, joints, and cartilage, the central nervous system, heart and vascular system, respiratory system...the skin, liver, kidneys,
EVERY organ and system of the body...including
DEATH!!

Previously HEALTHY, ACTIVE mom of twin boys, 20 pills of AVELOX and LEVAQUIN, 2003, drastically changed and completely interrupted my life, and the lives of those I love.

The physical and emotional trauma, the doctors who had all but LIED to my face...the doctors who had dismissed my pain and suffering...no less than a horrendous nightmare called my life....
all because of an "antibiotic"??!!

This class of "antibiotic", this DEADLY chemotherapeutic agent, needs more than a BLACK BOX....how about the TRUTH??!!

More ...



~Shells~
DEADLY AVELOX/LEVAQUIN 2003

Connie
Posted by Connie
July 13, 2008 1:26 AM

"The benefits outweigh the risks". That's what the FDA rep told me when I reported how Cipro had caused my husband to become disabled. That's not much of a consolation to know that you're only collateral damage. My husband took Cipro in 1998. Around 11 months later he had his first rupture. He had 2 more after that. He also started suffering from insomnia, vivid nightmares, involuntary movements of his arms & legs, suicidal thoughts & acts, severe depression, intestinal bleeding, tendonitis, muscle & joint pain & quite a few other symptoms after taking Cipro. For several years the rupturing had stopped. In 2004 he took CiproXR. Around 11 months later the ruptures began again. He had 3 ruptures in 2005. He became disabled after this. It's not just tendons, but ligaments & muscle too that tore. These happened in both his legs & arms. Tests confirmed he has neuropathies in his legs & hands. What good is the warning that says stop taking the medicine when many months later your tendons rupture with no warning? I have a problem with the "after" where it says rare occurrence of tendonitis & tendon rupture can occur while or AFTER taking medicine. Am I the only 1 who thought that the most AFTER meant was maybe 2 weeks? I sure didn't know it meant years. As far as "the benefits outweigh the risks", No they don't.

teri
Posted by teri
July 13, 2008 12:24 PM

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).

kls
Posted by kls
July 13, 2008 8:12 PM

I'm a 32 year old female, who was a victim of the Levaquin and Cipro, mainly Levaquin. Levaquin caused me toxic psychosis, brachial plexus nerve damage, achilies tendon issues. What the media is being told isn't true, there are more cases of people being affected, and they're younger than 60. They also haven't mentioned the people that have lost their lives because of these drugs.

david fuller
Posted by david fuller
July 17, 2008 3:11 AM

"So where is the corresponding letter to health care providers in the U.S. from Bayer about Avelox and its association with liver toxicity?"

One was issued over in Europe in February of this year (2008). Even though the label changes that prompted the European "Dear Doctor Letter" took place LAST year (2007) here in the States, a year before these changes took place over in Europe, the FDA has yet to request one and Bayer has yet to issue one. According to the drug reps I have spoken to Bayer has no intentions of issuing one here in the States either; unless forced to do so by the FDA as they were by the European authorities. It was also indicated to me that the FDA has no intentions of requesting such a letter either.

Lexi A
Posted by Lexi A
July 17, 2008 12:08 PM

I suspect Levaquin caused my horrid joint pain. I had some problems with my right knee before beginning Levaquin, but after taking 750 mg qid for a week for a UTI, I began waking with horrid stiffness and severe joint pain in nearly every joint in my body. I was given samples at the urgent care, so I didn't have a PI sheet to go over the possible ADRs. I am flaming pissed off about this because I am only 26, and I may feel like I live in the body of a 75 year old for the rest of my life. My GP says that it is so rare that things like this can happen, but I don't think it is as rare as she thinks.

L. Cochran
Posted by L. Cochran
July 17, 2008 12:41 PM

Having just discovered this revolting news, I am now investigating whether Levaquin caused me to have wrist tendon surgery, due to DeQuervain's, a specific type of tendonitis. After my sons's death a few months ago, I had a COPD/bronchitis exacerbation. They gave me prednisone and Levaquin at the same time. I am 66. Older people on steroids are especially at risk. Why didn't the doctors know this?

david fuller
Posted by david fuller
July 18, 2008 2:45 AM

Why didn't the doctors know this?

Several reasons. The first being nobody has bothered to tell them. The second they won't believe you if you tried anyhow.
The third being the FDA doesn't care. They are far more interested in protecting the profits of the drug manufacturers than they are the health and well being of the patient.

And even more damning is the fact that this information can be found within the package insert, but then Doctors will not take the time to read the package inserts, but rely upon the drug rep to keep them informed. Now what drug rep that wants to keep their job is going to dessiminate anything that makes the drug look bad?

Just read the transcripts of some of the advisory meetings concerning these drugs, you will be even further revolted. Heart attacks associated with Avelox. Drug approved. Disfiquring rashes associated with Factive. Drug approved. Fatal hypo and hyperglycemia associated with Tequin. Drug approved. Fatal liver damage associated with Trovan. Drug approved. 40% adr rate found with levaquin including a number of fatalities, as well as false data submitted with the NDA (efficacy based upon a drug other than levaquin). Drug approved. And on and on it goes.

Even this fiasco with this black box warning will have no impact what so ever. They are still approving new drugs within this class as well as new indications for those already in use while "studying" this reaction, and hiding the true safety profile from everyone. As sick as it gets my friend.

Even sicker is trying to find an attorney to represent you when your life is destroyed by these drugs. Good luck with that. Takes a medical expert to prove the drug is responsible. With everyone in the medical community denying this damage even taking place where are you going to find the expert? No expert, no case, no attorney. Just that simple.

Todd
Posted by Todd
July 18, 2008 5:50 PM

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.

Sincerely,


Todd Plumb MD

Gary Boyles
Posted by Gary Boyles
July 19, 2008 12:31 AM

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.

Sally
Posted by Sally
July 19, 2008 12:49 AM

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!
Sally

Kim Bean
Posted by Kim Bean
July 19, 2008 10:21 AM

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.

Rick Radcliff
Posted by Rick Radcliff
July 19, 2008 2:11 PM

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.

Laura Calderon
Posted by Laura Calderon
July 19, 2008 2:50 PM

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.

Laurie  Reylek
Posted by Laurie Reylek
July 19, 2008 5:56 PM

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

Lou
Posted by Lou
July 20, 2008 1:58 PM

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.

Lynne G
Posted by Lynne G
July 20, 2008 5:04 PM

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.

Leslea
Posted by Leslea
July 21, 2008 8:37 AM

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 More ... .
Thank you for your time.

Rose
Posted by Rose
July 21, 2008 3:47 PM

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.

Lesley
Posted by Lesley
July 24, 2008 3:12 AM

I had taken this class of drugs back at the end of April, only for 5 days. Since the end of May I have had mirgratory joint pain that is fleeting. I have been to 12 drs to find out why I have this pain as well as joint popping and buzzing in my feet. All tests are coming back clear.

Could this drug have caused my issues even though I was only on it 5 days and I started getting pains a month after?

I am not sure if it was cipro, but was in that class for possible MRSA/.

david fuller
Posted by david fuller
July 24, 2008 11:04 PM

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.
More ...
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.

Taylor
Posted by Taylor
August 01, 2008 12:38 PM

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. This one was for my right bicep and rotator cuff. I have to wait 3 months before I can undergo yet a fourth tendon rupture reattachment for the left side. I also suffer from Achilles Tendinopathy, joint pains, headaches, uncontrolled muscle twitching etc. For a sinus infection, I am sure there is a more suitable class of antibiotics that could have cleared this up. Fluoroquinolones should only be used as the drug of last choice.

Many people are walking out of their doctor’s office with a prescription in hand for one of these antibiotics to treat a sinus or bronchial infection. It’s a game of Russian roulette that they didn’t sign up to play. Many will wind back up in their doctors office or worse the ER to treat the side effects, only to be scuffed at because most physicians are unaware of these side effects or how to treat them. I hope that one person will read these blogs and think twice before popping one of these dangerous drugs.

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