January 16, 2006
WASHINGTON--The Food and Drug Administration (FDA) issued a public warning about two Brazilian weight loss pills, Emagrece Sim and Herbathin, which are marketed as dietary supplements but allegedly contain dangerous controlled substances and unapproved drugs. The agency urged consumers, health care providers and caregivers to cease using the products, and advised them to either dispose of the items or return them to suppliers. Further, FDA has increased its efforts to block importation of the products, which are distributed by Miami, Fla.-based Emegrece Sim Laboratories and Herbathin Inc. (dba EMIEX Corp.), and are also marketed on the Internet.
The two products contain chlordiazepoxide HCl (the active ingredient in the drug Librium®), which is used to relieve anxiety and control symptoms of alcohol withdraw. It may be habit forming and cause drowsiness and impair driving ability. The pills also contain fluoxetine HCl (the active ingredient in Prozac®), which has been linked to serious side effects, such as anxiety, insomnia, abnormal bleeding and suicidal thinking.
Both products, which are manufactured in Brazil by Fitoterapicos (aka Fytoterapicos) and Phytotherm Sim, are sold in paired single-bottles each containing a different formula. They are available in five levels, and consumers are advised to start at the lowest level, continuing to higher levels until they lose their desired amount of weight.
FDA advised any adverse events associated with the use of these two products should be submitted to its MedWatch voluntary reporting program, by calling 1-800-FDA-1088 or visiting http://www.fda.gov/medwatch.report.htm
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