FDA Sued for Stronger Warnings on Certain Antibiotics
Posted by
Jenny AlbanoJanuary 06, 2008 12:36 AMOn Thursday, December 3, a consumer group called Public Citizen sued the FDA, saying that the agency has ignored pleas for stronger warnings on antibiotics that can cause tendon injuries.
The labels on drugs such as Cipro and Levaquin, drugs in the fluoroquinolone family of antibiotics, do have warnings for tendon injuries, but they are listed among many other side effects are not emphasized. Public Citizen wants the tendon injury warnings to be upgraded to a black-box warning, the FDA's most severe warning. Also the consumer group wants patients who take this drug to recieve a pamphlet with their medication that explains the risks.
Public Citizen thinks that not very many patients who take this family of antibiotics knows they are supposed to discontinue use of their the medication if they experience 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 U.S. District Court for the District of Columbia.
When Public Citizen first filed this petition there were 262 reported incidents of ruptured tendons from November 1997 to December 2005, and there were a few hundred reports of other tendon problems in patients who took these kind of antibiotics. Since the end of 2005 the FDA has recieved 74 more reports of tendon ruptures. These numbers probably do not account for most of the tendon problems because only a fraction of drug side effects are typically reported to the FDA.
For more information on this subject, please refer to our section on FDA and Prescription Drugs.