The FDA ( US Food and Drug Administration ) has rejected a petition to ban the sale of Meridia, an obesity drug, manufactured by Abbott Laboratories.

Public Citizen petition, dated March 19,2002 , requested to the Food and Drug Administration ( FDA ) to remove Meridia ( Sibutramine ) from the market because of adverse events associated with the drug.

On September 3, 2003 Public Citizen submitted an update report on the adverse events for Sibutramine covering the 18-month period subsequent to petition ( October 1,2001, through March 31,2003 ).
The supplement also included new information on fetal adverse events.

FDA approved Knoll Pharmaceuticals’new drug application ( NDA ) for Sibutramine ( 5 mg, 10 mg, and 15 mg ) for the management of obesity, including weight loss and the maintenance of weight loss, in November 1997.

Abbott Laboratories acquired Knoll Pharmaceuticals on March 2, 2001, and currently holds the NDA for Meridia.

In March 2002, the Italian Ministry of Health temporarily suspended the marketing license for Sibutramine in response to reports of serious adverse reactions, including two fatalities.
Based on this experience, the Italian health authorities requested that the European Agency for the Evaluation of Medicinal Products’ Committee for Proprietary Medicinal Products ( CPMP ) provide an opinion on whether Sibutramine’s marketing authorization should be maintained, changed, suspended, or withdrawn.

After reviewing available efficacy and safety data, including the cases reported in Italy, the CPMP rendered a favorable opinion on June 27,2002, and recommended that the marketing authorization for Sibutramine be maintained.

On August 28, 2002, the Italian Ministry of Health reinstated Sibutramine’s marketing license.

Source: FDA, 2005


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