Cipro-Talk.com

Archive for July, 2008

Cipro’s association with tendon ruptures was recognized long before the Food & Drug Administration (FDA) asked for a black box warning on the risk. In fact, several victims of the 2001 anthrax attack filed lawsuits claiming Cipro caused a variety of ills, including tendon damage. What’s more, a prominent consumer group first warned about the tendon risk associated with drugs in the same class as Cipro well over 10 years ago.

In 2002, four US postal workers from New Jersey - all of whom were exposed to anthrax - sued Bayer Corp. claiming the company failed to disclose data that Cipro could damage nerves and tendons. One of the plaintiffs, mail handler James Sherman said he developed pain in his elbows, knees and groin shortly after taking Cipro. “I later complained to the hospital,” Sherman told The Star-Ledger of Newark. “But now, I walk like I’m crippled all the time. I never had these aches and pain before.”

It was only last week that the FDA asked the makers of Cipro and similar antibiotics to add a black box warning about the risk of tendon ruptures to their labels. But the advocacy group Public Citizen raised the alarm about tendon damage more than a decade ago. In 1996, the group first petitioned the FDA for a tendon damage warning. The FDA that year granted the petition, but the warning was buried in the list of possible adverse reactions and proved inadequate.

In 2006, as reports of tendon damage linked to Cipro and its related antibiotics continued to grow, Public Citizen petitioned the FDA for a stronger black box warning. But the FDA never responded to that petition. This past January, Public Citizen sued the FDA to compel it to take action. With the lawsuit looming, the FDA finally took appropriate action to warn consumers of this dangerous Cipro side effect.