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The consumer advocacy group Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to ban the diet drug Meridia (sibutramine). A news release from Public Citizen cites more than two dozen deaths and 397 adverse reactions reported to the FDA since the drug's introduction in 1998.
Calling the drug "unacceptably dangerous" in its petition, Public Citizen said that 19 of those deaths were caused by heart complications in people taking the drug.
"The effect of sibutramine in promoting weight loss is meager and it is not known if this drug, or any diet drug for that matter, can be safely taken for a long enough period of time to reduce the morbidity and mortality associated with obesity," Dr. Sidney Wolf, director of Public Citizen, wrote in a letter to Tommy Thompson, secretary of the U.S. Depart-ment of Health and Human Services.
In its petition to have the drug removed from the market, Public Citizen noted that the FDA had raised concerns about the drug's safety even before it was approved for marketing.
"An FDA advisory committee in 1997 voted 5-4 that the benefits of the drug did not outweigh its risks. The FDA medical officer who reviewed it recommended that it not be approved because research showed the potential for heart problems," according to the petition.
The drug is available in 70 countries and is sold under the name Reductil in Europe. Public Citizen said that the medication is being scrutinized by European health officials, adding that the Italian government pulled sibutramine from the shelves following two deaths attributed to the drug in that country.
European health regulators have received hundreds of reports of side effects in people taking the drug. The European Medicines Evaluation Agency will be conducting a European-wide review of these reports.
Abbott Laboratories, the maker of the diet drug, says it is aware of the deaths but believes there is no evidence that the deaths are related to the drug.
0 comments - Jun 1, 2002
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.