FDA to Block Import of Diet Pills, Warns Public 27414

February 6, 2006

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FDA to Block Import of Diet Pills, Warns Public

WASHINGTON The Food and DrugAdministration (FDA) issued a public warning Jan. 13 about two Brazilian weightloss pills, Emagrece Sim and Herbathin, which are marketed as dietarysupplements but allegedly contain dangerous controlled substances and unapproveddrugs. The agency urged consumers, health care providers and caregivers to ceaseusing the products, and advised them to either dispose of the items or returnthem to suppliers. Further, FDA has increased its efforts to block importation ofthe products, which are distributed by Miami, Fla.-based Emegrece SimLaboratories and Herbathin Inc. (dba EMIEX Corp.), and are also marketed on theInternet.

The two products contain chlordiazepoxide HCl (the activeingredient in the drug Librium®), which may be habit forming and causedrowsiness and impair driving ability. The pills also contain fluoxetine HCl(the active ingredient in Prozac®), which has been linked to serious sideeffects, such as anxiety, insomnia, abnormal bleeding and suicidal thinking.

FDA advised any adverse events associated with the use ofthese two products should be submitted to its MedWatch voluntary reportingprogram, by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch.report.htm.

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