FDA Warning: Brazilian Diet Pills
According to the FDA, the agency has increased its efforts to prevent the importation of both Brazilian-made products by issuing an alert to its field personnel. These alerts serve to inform and advise FDA personnel about certain imported products that should not enter the United States.
Emagrece Sim and Herbathin, which are both labeled as “dietary supplements” actually contain prescription drugs, including chlordiazepoxide HCI (the active ingredient in Librium), and fluoxetine HCI (the active ingredient in Prozac). According to the FDA, “Chlordiazepoxide HCI (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. Fluoxentine HCI (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 serious adverse events, including suicidal thinking behaviors in pediatric patients, anxiety and insomnia, and abnormal bleeding.” The FDA also advises that these drugs should only be taken by patients who are under the supervision of a health care provider. Furthermore, both drug products contain Fenproporex, a stimulant that is not approved for marketing in the United States. “Fenproxporex 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.”
Both products, which are offered for sale on the Internet, are also imported and distributed by laboratories in Miami, Florida. The FDA urges consumers, health care providers, and caregivers not to use the products, to either return them to suppliers, or dispose of them, and to report any adverse events related to the products to MedWatch, the FDA’s voluntary reporting program at 1-800-FDA-1088. Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research warned that “there are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality, as these are not approved by the FDA and if people experience side effects, it is difficult to trace problems and for physicians to treat them.”