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.