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The U.S. Food and Drug Administration (FDA) is warning consumers not to use two unapproved drug products that are being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury.
Both products are made in Brazil by Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim. FDA has increased its efforts to prevent the importation of these products by issuing an alert to its field personnel. Import Alerts are used to advise FDA field personnel about certain imported products that should not enter the United States.
Consumers are advised not to use the Emagrece Sim and Herbathin products and to return them to the suppliers. There may be other manufacturers or suppliers of imported Emagrece Sim and Herbathin, and consumers should exercise caution in using any of these imported products.
"There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "These products are not approved by FDA and if people experience side effects, it is difficult to trace problems and for physicians to treat them."
Emagrece Sim and Herbathin are labeled as "dietary supplements", but they contain prescription drugs, including several controlled substances that, if not used properly as prescribed by a physician, can be harmful. They contain 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.
Emagrece Sim and Herbathin were also 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.
Emagrece Sim and Herbathin are sold in packages containing one bottle of Formula 1 capsules and one bottle of Formula 2 capsules. Both products are available in five levels (Levels 1-5), and the product labels instruct consumers to begin with Level 1 and continue to the higher levels until they lose the desired amount of weight. Emagrece Sim also has a "Weight Stabilizer" package containing Formula 1 and Formula 2 capsules, to be used after the desired weight loss has been achieved.
The products are offered for sale on the Internet. They are also imported and distributed by Emagrece Sim Laboratories, Inc., Miami, FL., and Herbathin, Inc. (dba EMIEX Corp), Miami, Florida. FDA is aware of commercial imports of these products and individuals importing them for personal use.
FDA urges 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; or online at www.fda.gov/medwatch/report.htm.
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