Sibutramine to be Sold Again in Italy
August 29, 2002
Italy's Health Ministry announced this week that it will re-introduce the diet drug sibutramine, sold in Europe as Reductil and the United States as Meridia, to the market with specific limitations. In March 2002 the agency suspended the sale of products containing sibutramine after fifty "adverse events" were associated with the drug. But after an extensive review by the European Agency for the Evaluation of Medicinal Products' Committee for Proprietary Medicinal Products, the diet drug's benefits were determined to outweigh its risks.
New regulations implemented state that the medication can only be prescribed by an internal medicine physician, a cardiologist or an endocrinologist. A new warning label will advise of the dangers the drug presents to patients who have glaucoma. Users will also be required to keep a diary while taking sibutramine to help properly monitor the drug's side effects. Although several public interest groups have asked the U.S. Food and Drug Administration (FDA) to ban Meridia, the drug is still available in the U.S. without restrictions.
-- Article Courtesy of InjuryBoard.com
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