Washington, D.C. - Public Citizen, a nonprofit consumer advocacy organization, has petitioned the Food and Drug Administration (FDA) to remove the drug Meridia from the market.
The Abbott Laboratories' prescription weight-loss drug is used by nearly a quarter of a million people in the United States. Meridia was approved in 1997, and is now registered in eighty countries.
The petition is a response to the Sibutramine Cardiovascular Outcome Trial (SCOUT) study involving 10,000 people in sixteen countries showed a higher risk of heart related problems. Patients were more likely to show significant electrocardiogram changes when compared to those taking placebos.
Public Citizen filed a similar petition in 2002. The FDA rejected the charge, stating that they wanted to wait for the findings of the SCOUT study.
An Abbott spokesman pointed out that Sibutramine (Meridia) would not have been prescribed to 90% of the participants in the study.
Public Citizen claims that 84 deaths have occurred in association to Meridia as of June, 2009.