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Cipro, Levaquin Still Popular Despite Tendon Risks

Jan 5, 2009 | Parker Waichman Alonso LLP

Despite the fact that Cipro, Levaquin and other antibiotics called fluoroquinolones have been linked to serious tendon damage - including ruptures of the Achilles heel - not many patients are aware of the risk.  According to an article in The Atlanta Constitution-Journal, drugs like Cipro and Levaquin are still being over-prescribed at an alarming rate in spite of this danger.

The first fluoroquinolone was introduced in 1986.  Critics of these drugs allege that fluoroquinolone antibiotics were developed and put on the fast track for Food & Drug Administration (FDA) approval without the benefit of adequate premarket testing to accurately determine the probability of certain side effects within the general population. After gaining FDA approval, the new fluoroquinolone antibiotics were aggressively marketed by the manufacturers.

Cipro became widely known when it was used to treat and prevent anthrax infections in people exposed to the virus as a result of the 2001 mail attacks.  While Cipro was apparently an effective weapon against anthrax, it left some victims with lingering health problems.

Last July, the FDA asked the manufacturers of Cipro and other fluoroquinolones to add a black box warning to the drugs’ labels about their association with tendon damage.   The FDA said the risk of tendon damage was  greatest for those over age 60, those on concomitant steroid therapy, and  kidney, heart, and lung transplant recipients. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. At the time of the warning, he FDA has received nearly 2,250 reports of tendon disorders and 775 reports of tendon ruptures among patients taking fluoroquinolones, though the actual numbers are likely much greater since most side effects are never reported.

According to the Atlanta Constitution-Journal, the tendon risks associated with fluoroquinolones have been known for close to 20 years.  The FDA warning only came after the agency was sued by a consumer group for ignoring the drugs' safety risks.

When the FDA finally had the makers of these drugs add warnings to their labels, it stopped short of requiring that drug companies send letters to doctors alerting them of the change.  Only a few, such as Bayer HealthCare Pharmaceuticals the maker of  Cipro and Avelox, and Oscient Pharmaceuticals, which sells Factive, have voluntarily done so.

As a result, fluoroquinolones are still being prescribed at a high rate, despite the fact that there are safer alternatives.  According to the Atlanta Constitution-Journal, in 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics.  What's worse, studies have shown that these drugs are often used to treat diseases that don't even respond to antibiotics.

The fact that few doctors and patients are aware of the risks of fluoroquinolones is a serious concerns.  The tendon damage often caused by these antibiotics can be mitigated if patients are treated - and switched to another antibiotic - as soon as they start feeling pain.  But without the right knowledge, most won't even know the medicine they are taking could be causing their discomfort.  If they continue taking the drug, the result could be a tendon rupture, which will require even more intervention - including surgery.