FDA denies petition over Abbott weight-loss drug
The FDA has denied consumer group Public Citizen's petition to take Abbott Laboratories' weight-loss drug Meridia off the market.
The agency said yesterday it has determined the drug's benefits continue to outweigh its risks for certain obese patients.
Public Citizen lodged its complaint three years ago, charging that Meridia contributed to dozens of deaths and more than 400 adverse patient reactions since the drug was launched in 1997. The drug again came into focus last fall when it was listed among five potentially dangerous drugs the FDA needed to review, according to agency safety officer David Graham.
"With Meridia, I think seriously we have to consider whether there's just a need for the product in the first place," Graham said last fall.
On Tuesday, Public Citizen said the FDA made the wrong call in allowing the drug to remain on the market.
"This means the FDA has made another mistake," Public Citizen's director of health research, Sidney Wolfe, told The Chicago Tribune. "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."
Global sales of Meridia hovered around $300 million last year.