Cipro, Levaquin and other antibiotics known as fluoroquinolones have long been known to cause serious side effect, including tendon damage. Yet despite massive amounts of evidence, the Food & Drug Administration (FDA) has not required the makers of Cipro, Levaquin and other fluoroquinolone antibiotics to add warning labels about their links to ruptured tendons and other tendon problems. Now, the consumer advocacy group Public Citizen is trying to force the FDA to act, and has taken it to court in attempt to compel the agency to add black box warnings about tendon problems to the labels of these antibiotics.
Fluoroquinolones are used to treat bacterial infections in many different parts of the body. They work by killing bacteria or preventing their growth. From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. But Public Citizen contends that only a small fraction of cases are typically reported to the FDA, so the actual number of ruptures and other tendon injuries attributable to the antibiotic is probably much higher.
Public Citizen announced yesterday that it had sued the FDA in the U.S. District Court for the District of Columbia over the issue of floroquinolone antibiotics and tendon damage. Public Citizen wants the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. So far, the FDA has failed to respond to the petition, which asked the agency to put a “black box” warning on fluoroquinolone antibiotics to make doctors and patients are more aware of the risk of serious tendon injury before tendons actually rupture.
The Public Citizen petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled. In a press release announcing the antibiotic lawsuit, Public Citizen asserted that stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics. “While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The current warning is buried in a long list of possible adverse reactions and is far too easy to miss.”
Public Citizen said in its complaint that by failing to act upon its fluoroquinolone petition, the FDA is violating the Administrative Procedure Act.
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April 24th, 2009 at 7:55 pm
For a least the past 6 wks I have been suffering with acute pain in both arms and across the shoulders after taking levaquin for about 5 days. This has been a hardship for me as I am 71 yrs and have other issues. Will this ever go away?
May 12th, 2009 at 11:06 am
i was treated with avelox 400 mg in april 2007 when i was diagnosed with bronchitis.i developed swelling,pain and difficulty walking. when i first saw an orthopedic doctor, he thought i had tendonitis and ordered x-rays. i also was sent for special orthotics and support shoes.the pain and swelling did not subside.i saw an article about the side effect of avelox which was tendon rupture.i again saw my doctor who ordered an mri. this did show rupture of the tendon. in may 2008 i had a surgical repair of the tendon in my right ankle. i was in a wheelchair for two months and had physical therapy from 7/9/08 until 9/8/08. i still have slight swelling in my right foot,discomfort if i am on my feet too much and must wear support shoes.i think if i had known about the possibility of having my tendon rupture from taking avelox, i would have requested a different antibiotic.
May 16th, 2009 at 9:49 pm
From the information I have read, this can continue for 6 months.
I was on Levaquin by IV and 4 days after finishing it my Achilles tendon ruptured.
I am very nervous about another injury as it says it can continue for 6 months.
June 9th, 2009 at 6:49 pm
I am suffreing with acute shoulder pain in my left shoulder and arm and right shoulder it gives me trouble all the time its been hard for me it bothers me the most on my left side.I have used ciprofloxacin for awhile and have been to the er and hook up to iv for hrs.I dont know what to do.
July 20th, 2009 at 7:09 pm
I took levaquin for 7 days in June of this year (2009) as I was told I may have a small amount of bacteria causing aurinary tract infection. It made me dizzy and I felt just aweful while on it. I had been out of town (halfway across the country) for my Mom’s funeral. I had just drven 17hrs straight to get there and was now feeling sick while there. I left about a week later and had to drive back. It took me many overnight stops loaded down with ice packs all over the shoulders and legs to make it home and then, the first day home, I had horrible pain in the back of my left ankle. I told my family Doc and he said to rub some of this medicine on it. I didn’t as that night, the pain got a little better. I still suffer greatly with shoulder, wrist, & neck pain and now stumbled onto this website. I’ll be going to a major Hospital for another reason at the end of this week and ask my GI surgeon about his thoughts.
October 2nd, 2009 at 7:48 am
I had pneumonia and was given levaguin. I have tendonitis in both my ankles and my right hand. very painful. It has been over a month since I stopped taking the medicine but the pain is persistent.
November 23rd, 2009 at 11:09 am
2002 i got pneumonia and got removed gal bladder that which i got staphi infection in my lungs and got bleed to death with lost 6 pints of bleed in my stomach from gal bladder been in icu twice and stay hospital for 64 days and they gave me levaguin in iv my neck that which i have been complain from my back hurts from muscle pains the doctor did not find anything wrong but my supsect that levaguin that cause my back muscle hurts the mostly i need some help with lawsuit please email me back asap thanks