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Emagrice Sim Dietary Supplements, also known as the Brazilian Diet Pill, on Jan. 13, 2006 became the subject of a U.S. Food and Drug Administration warning in which consumers were urged not to take the pills and return them to suppliers.
The FDA said the supplement contains "several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury."
The FDA said that while Emagrice Sim was being sold as a supplement, it contains "chlordiazepoxide HCl (the active ingredient in Librium), and fluoxetine HCl (the active ingredient in Prozac). Chlordiazepoxide HCl (Librium) is used to relieve anxiety and to control the symptoms of alcohol withdrawal. It may be habit forming, and can cause drowsiness and dizziness and impair the ability to drive.
"Fluoxetine HCl (Prozac) is an anti-depressant medication used to treat obsessive-compulsive disorder, panic disorder, and bulimia. It has been linked to several serious drug interactions and certain serious adverse events, including suicidal thinking and behaviors in pediatric patients, anxiety and insomnia, and abnormal bleeding. These drugs should only be taken by patients who are under the supervision of a health care provider," the FDA said..
The agency said Emagrece Sim also was found to contain Fenproporex, a stimulant that is not approved for marketing in the United States. Fenproporex is converted in the body to amphetamine, and as a result has been noted to show up in urinalysis as a positive test for amphetamines.
The FDA said it was urging consumers, health care providers, and caregivers to "cease using and dispose of these products and report any adverse events related to these products to MedWatch, the FDA's voluntary reporting program at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787."w.fda.gov/medwatch/report.htm. |