FDA Warns Of Tendon Risk For Antibiotics

Officials: Cipro And Similar Drugs Can Cause Tendon Ruptures That Leave Some Incapacitated

(AP)  Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery.

The Food and Drug Administration ordered makers of flouroquinolone drugs - a potent class of antibacterials - to add a prominent "black box" warning to their products and develop new literature for patients emphasizing the risks.

Tendon ruptures are normally thought of as sports injuries, generally occurring among men in their mid-30s. The link to treatment with the antibiotics is highly unusual, and scientists still don't fully understand why it happens. However, FDA officials stressed that many of the serious injuries appear to be preventable if patients stop taking the drug at the first sign of pain or swelling in a tendon, call their doctor, and switch to another antibiotic.

The two leading drugs covered by the warning are Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil. Cipro became a household name during the anthrax attacks of 2001. It is effective against that deadly bacteria, and is among the drugs stockpiled by the government in case of a bio-terror attack. In everyday medicine, Cipro is often used to treat urinary tract infections. Levaquin is generally used to treat respiratory infections. The FDA warnings do not apply to fluoroquinolone drops used to treat eye infections.

The FDA's action came after the consumer group Public Citizen petitioned - and later sued - the agency for such warnings. Regulators took too long to act, complained Sidney Wolfe, head of the consumer group's health section. Many injuries "would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture," Wolfe said. Public Citizen's original petition was filed nearly two years ago.

FDA officials pointed out that prescribing literature for the drug class already carried clear warnings of the risk of tendon rupture. They said the agency acted to emphasize the warnings because continued reports of injuries indicated that the message may not have gotten through to doctors and patients.

"The continued reports demonstrate additional steps are warranted to better manage the risk of tendon rupture," said Renata Albrecht, director of an FDA office that focuses on unusual microbes.

FDA officials said they had received several hundred reports of tendon ruptures, but would not cite a specific number. Wolfe, of Public Citizen, said the number was 407 at the end of 2007, with another 341 reports of tendinitis. He continued to criticize the agency, saying it should also require drug makers to send individual letters to doctors about the risks. FDA officials said manufacturers could choose to send such letters on their own.

Tendons are cords of tissue that join muscles and bones, and are essential in movement. The most common kind of rupture reported to the FDA involved the Achilles tendon in the heel, but some also involved the rotator cuff in the shoulder, and tendons in the hands, biceps, and even the thumb.

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

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

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

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

This is a "Classic Example" of the poisons that the FDA approves for tremendous profit for Big Pharma. When will the madness end?

[midyettj]

I took Cipro two and a half years ago. I took two pills ONLY--ever--and the next day my legs hurt so bad I was writhing in pain. My achilles tendons were red and inflamed. They hurt from the bottoms of my heels to the top of my hamstrings. I immediately stopped taking the Cipro. However, I could not walk for over a week. I used crutches or a wheelchair. I could not drive for about three months. I could not exercise for about six months. I could not stand on my tip-toes for over a year. I could not run for a year and a half. Fortunately my achilles tendons did not rupture, but I emphasize that I took the pill for ONE day and as a result suffered severe pain for months. I gained weight due to lack of exercise and I still cannot run far or hike far. My doctor was skeptical and completely ignorant about the side effects. At first he attributed my inflammation and pain to injury (I was limping on both feet which injury doesn''t tend to cause; I had previously run a 15-minute mile on even grass, three times a week for a decade). Eventually, he agreed it must have been the Cipro, but neither he nor the drug company could give me any advice about getting better. I have gotten 90% better with time, but I had to be very careful not to injure. It was not worth the risk. I would rather have lived with the throat infection for which the antibiotic was prescribed. I am very hesitant about taking any medications now because they affect the quality of life.

[immeltingtoo]

A little more than a week ago I was prescribed cipro
for a urinary tract infection. Almost immediately
I developed severe patellar tendon pain. I
attributed it to an ongoing left knee problem/injury
from years ago. However, since it was so intense I
thought it was the arthritis acting up. After
reading the literature on the med. I was suspicious,
but still couldn''t believe it had anything to do with
the Cipro. This afternoon I was talking to someone
at the grocery store who said she had just heard
about the problem on the news. I am NOT happy and
plan to confront my physician on this matter.

[sturg71]

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[toldyouso12]

. My arms/hands are in excruciating pain and have no strength. This is horrible. And apparently, the drug company is not responsible. I will not get better. Ever. My quality of life has been destroyed by this drug. Ortho-McNeil decided to take a chance with my health and future and did not make necessary information available to me so that I might decide for myself. I am only 36. I can not pick up a glass of water. Someone need to explain how this is legally or morally right.

Posted by poppyd2 at 07:51 PM : Jul 08, 2008


Why do you say that the drug co cannot be held accountable? Of course they can--esp once the warnings are placed on the items. All a lawyer had to do is get the batch records and research data for this product and if it is proven that the known side effects were not listed and or covered prior to your receiving this drug or if the information was in any way hidden, you can sue. Its called fraud. When the batch record is reviewed, you want to look at all ingredients and any established side effects, any temp deviations, or testing deviations as well as the brand name of the raw materials, if they were approved and tested, etc.

Believe this, if you want to get a Pharm mfg company for negligence, it is far easier than most people and lawyers realize--they invariably are almost always doing something questionable, or illegal and will often settle than have their product batch recalled or have their practices come to light and face more lawsuits.

[mdob6]

Not just tendon ruptures and muscle pain are adverse side effects of fluoroquinolones, nor, as manufacturers state, is this rare. Many people have no idea their damage has been caused by these drugs, nor, do their Drs. So who reports these problems to the FDA? Almost no one. However, the drug companies and the FDA have known about the relationship between fluoroquinolones and tendon tear for years, due to sites such as www.fqresearch.org and www.fluoroquinolones.org, who have pushed to get black box warnings on these drugs. There are other side effects caused by these drugs which can effect all organs, peripheral and central nervous systems, etc. Some of the other serious effects include: palpitations, dizziness, weakness, racing heart, anxiety, nervousness, numbness, tremors, insomnia, etc.(all listed in the package inserts of these drugs). These side effects don''t always stop when the drug is stopped. I was a very healthy 53 yr old man when in sept. 07 I was given a 10 day course of Cipro for an infection. It is now 9 months later and I am still having serious side effects, enough so that I still cannot return to work (palpitations, anxiety, racing heart, severe tinnitus, insomnia, dizziness, and of course muscle and joint pain). This drug was poison to me. These are not rare side effects no matter what the drug companies or their partners, the FDA, say. Unfortunately most Drs. are ignorant of the severe, wide spread problems caused by fluoroquinolones.

[poppyd2]

Why has no one noticed this before. I took Levaquin 12/07 and was not alerted to the possible tendinopathy side effects. I developed such severe pain and loss of strength while taking it that I called my pharmacist to see if the antibiotic could possible be causing it. After my pharmacist researched this he was able to find the "rare and unusual" side effect hiddin under six pages information. I have Fluoroquinolone induced tendinopathy in all of my tendons from the base of my skull down to the middle of my spine and throughout both arms. I have to get cortisone shots in my tendons every 3-4 weeks. My arms/hands are in excruciating pain and have no strength. This is horrible. And apparently, the drug company is not responsible. I will not get better. Ever. My quality of life has been destroyed by this drug. Ortho-McNeil decided to take a chance with my health and future and did not make necessary information available to me so that I might decide for myself. I am only 36. I can not pick up a glass of water. Someone need to explain how this is legally or morally right.