Public Citizen Petitions FDA To Ban Abbott Diet Drug Meridia In December 2009

This Is Second Request For Meridia Recall By The Consumer Group; Its First Petition Was Filed In 2002, Denied In 2005

In early December 2009 Public Citizen filed its "Petition to Ban Sibutramine (Meridia)" with the FDA, in which this consumer group requested that Abbott Laboratories Inc's weight-loss drug Meridia be banned immediately because of heart-related side effect risks.

In its December 2009 Petition, Public Citizen said early results from a large international study called SCOUT added to the consumer group's previous safety concerns -- which were first expressed in Public Citizen's March 2002 FDA Petition regarding Meridia -- that Meridia could cause heart attacks, strokes, and other serious cardiac problems: "The fact that [Meridia] actually increased the number and percentage of cardiovascular events [in the SCOUT study] ... should mandate its immediate removal from the market."

Back in November 2009 the FDA issued an "Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)" to let the public know about a possible increased risk for adverse cardiovascular events associated with the obesity drug Meridia.

Returning to the December 2009 Meridia Petition submitted to the FDA, Public Citizen said 84 heart-related deaths had been reported to the FDA in patients who took Meridia; 30 of the people who died were age 50 or younger, and 11 were age 30 or younger.

As mentioned above, the FDA rejected an earlier Petition to ban Meridia from Public Citizen. In its 2005 decision the FDA said that Meridia's benefits outweighed its risks when used appropriately, adding that it was not possible to conclude that Meridia had caused the reported heart-related side effects.

However, the FDA stated in its 2005 denial that an assessment of Meridia's heart risks could best be made though a large trial, such as the SCOUT study -- a point which Public Citizen emphasized in its most recent "Petition to Ban Sibutramine (Meridia)".

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