Group Sues FDA For Stronger Warnings

WASHINGTON (AP) — A consumer group sued the Food and Drug Administration January 3, charging the agency is ignoring calls for stronger warnings that Cipro and similar antibiotics may cause serious tendon injuries.

Labels of the fluoroquinolone family of antibiotics — drugs that include the popular Cipro and Levaquin — already warn about rupture of tendons and other tendon injuries, but at the bottom of a list of other side effects.

The consumer group Public Citizen wants those warnings upgraded to the FDA’s most severe type, a so-called black-box warning — and for patients to get pamphlets with every bottle that describe the risk. It argues that too few patients know they are supposed to quit using the drugs if they experience symptoms such as pain or inflammation, before the tendon actually ruptures.

Public Citizen filed a petition seeking the stronger warning in August 2006. The state of Illinois had filed a similar petition the previous year.

The FDA is violating its own statutes and putting patients at risk in taking so long to settle the issue, Public Citizen said in the suit filed in US District Court for the District of Columbia.

When Public Citizen first filed the petition, FDA’s database showed 262 reports of tendon ruptures between November 1997 and December 2005, along with hundreds of other tendon problems in users of these antibiotics. Since then, the FDA has received an additional 74 reports of tendon ruptures, said Public Citizen’s Dr Sidney Wolfe.

Only a fraction of drug side effects typically are reported to the agency, he noted. An FDA spokesman said the agency was evaluating the lawsuit and declined comment.