The Issue Of Whether FDA Should Recall Meridia Because It Is An Unsafe Drug Is Not "New" In 2010

Public Citizen Submitted Its First Petition To Ban Meridia Back In 2002

During early March 2002, a prescription diet medication called Meridia (sibutramine) came under suspicion for being an unsafe drug in the United States and in Europe.

On March 19, 2002, a petition was filed with the FDA requesting a Meridia recall in the U.S. The petition contends that: (1) Meridia is a dangerous drug; (2) Meridia should not have been approved by the FDA in the first place; and, (3) in the interest of safety, there should be an immediate Meridia recall. The entire Public Citizen Petition is available.

Meridia was first sold in the U.S. during February 1998. From that time until October 2002, almost 400 serious adverse reactions had been reported to the FDA for people who were taking the diet drug Meridia. The FDA data reveals that 29 of those people died, including 19 with cardiovascular causes of death such as heart attacks. As for the 19 cardiac deaths, 10 involved a person 50 years or younger, and 3 involved women under the age of 30. In addition to those deaths, 152 people were hospitalized due to serious Meridia side-effects.

In fact, the United States Food and Drug Administration (FDA) expressed concern about the safety of Meridia even before it approved this weight-loss drug in 1997. An FDA advisory committee had voted 5 to 4 that the benefits of Meridia did not outweigh its health risks. Further, the FDA medical officer who reviewed Meridia had recommended that this diet drug not be approved because research showed the potential for heart problems.

About a week after the March 2002 Italian ban on sibutramine, a spokesman for Abbott Laboratories said that the company had received reports of 34 deaths in people who were taking sibutramine, with 28 in the U.S., 2 in Italy, 2 in Britain, 1 in Switzerland, and 1 in South Africa.

Meridia (sibutramine) is sold in the United States by Abbott Laboratories. Meridia is manufactured for Abbott by BASF Corporation.

More recently, in December 2009 Public Citizen submitted a second FDA Petition to ban Meridia after the results of a lengthy and large-scale Meridia study were released, with that new safety data strengthening the apparent connection between Meridia and dangerous heart-related side effects.

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