FDA delays action on Meridia petition

Medical Marketing and Media, Dec 2002 by Dickinson, James G

The FDA has delayed taking any action on a petition seeking the withdrawal of Abbott Laboratories' weight-loss drug Meridia (sibutramine) on safety grounds. The FDA's director of drugs, Janet Woodcock, recently wrote Public Citizen Health Research Group Director Sidney Wolfe informing him that the agency had not yet completed its review and analysis of the issues surrounding the group's petition last March seeking a ban on Meridia.

She did not indicate how long the delay would be. The petition had argued that Meridia should be removed from the market because the drug is "minimally-effective" and has been associated with 29 deaths, including 19 from cardiovascular adverse events, since its approval.