September 2003: Public Citizen Supplements Its Meridia Petition To Show More Reports Of Heart-Related Side Effects

Public Citizen Again Urges FDA To Ban Diet Drug Meridia Due To Increasing Number Of Cardiovascular Adverse Events

On September 3, 2003, a consumer organization called Public Citizen sent a letter supplementing its March 2002 Petition to FDA to ban the diet drug sibutramine . The March petition calls Meridia "the unacceptably dangerous prescription diet drug Meridia" and notes that other health regulatory agencies, such as the Italian Health Ministry, were investigating Meridia after reports of "29 deaths including 19 from cardiovascular adverse effects in people using this minimally effective drug."

This September 2003 Public Citizen letter urges the FDA to act on the March 2002 petition "due to the rising number of cardiovascular events" associated with Meridia. The letter states that to date, there have been 49 cardiovascular deaths attributable to Meridia, in addition to other unacceptable side effects, such as:

• large, sustained increases in blood pressure
• increased risk factors for heart attacks and cardiac arrest

According to Public Citizen, since Meridia was put on the market in 1988, there were 124 serious cardiovascular events requiring hospitalization, in addition to the deaths. Of the 30 most recent deaths occuring in the past 18 months, 25 reports provided ages, and 68% were younger than 50.

The FDA denied this petition in 2005 saying 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.

UPDATE:  Following its review of recent data from the SCOUT study, in early 2010 there was some indication that perhaps the FDA has changed its safety assessment of Meridia.  The FDA announced on January 21, 2010 that Abbott will have to revise the Meridia package insert to indicate that this weight-loss drug should not be taken by patients with a history of cardiovascular disease because of an increased risk of heart-related side effects such as heart attack and stroke.

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