Abbott's Weight-loss Drug Meridia Gets a Confidence Vote by FDA

FDA Denies Public Citizen's Petition to Remove Meridia from Market
   

The FDA has decided that the benefits of Abbott Laboratories' prescription weight-loss drug Meridia continue to outweigh the drug's risks for select obese patients.  As such, on August 16, 2005 the FDA denied a petition that had filed by the consumer advocacy group Public Citizen three years ago asking the FDA to take Meridia off the market in the U.S.

Public Citizen filed its petition with the FDA because the group alleged that adverse event reports made to the FDA showed Meridia having contributed to more than 400 adverse patient reactions, including dozens of fatalities, since Meridia was approved by the FDA in 1997.

Meridia has had a checkered past as regards whether or not it should be on the market.  At the outset, an FDA advisory panel voted 5-4 against marketing approval for Meridia in 1996.  After the filing of the Public Citizen Meridia petition three years ago, attention to the drug-safety issues for Meridia faded for awhile.  However, those issues were at the forefront, again, in the fall of 2004 when FDA safety officer Dr. David Graham listed Meridia among five potentially dangerous drugs the agency needed to review -- a list that also included  Crestor (cholesterol drug), Bextra (painkiller), Accutane (acne drug), and Serevent (asthma medicine).

In more detail, the Public Citizen petition framed this issue for the FDA: Does Meridia's benefits outweigh the risks of high blood pressure and stroke.  Commenting on the FDA's decision to deny their petition, Public Citizen said the FDA's decision about the safety of Meridia was misguided and issued a statement by Sidney M. Wolfe, MD, Director of Public Citizen’s Health Research Group.  "This means the FDA has made another mistake," said Dr. Wolfe. "A lot of the people who died from this were very young, in their 20s, 30s and 40s. It is very difficult for the FDA to admit they made mistakes."

One hopes that for the sake of those people who are using Meridia, the FDA has made the right decision, here.

(Posted by: Tom Lamb)