The FDA has issued a warning to consumers that diet pills from Brazil have been found to contain active drug ingredients which are possibly harmful.
The pills Emagrece Sim and Herbathin Dietary Supplements are unapproved drug products and are being marketed as dietary supplements for weight loss.
Emagrece Sim, also known as the Brazilian Diet Pill and Herbathin Dietary Supplement contain controlled substances, found in prescription drugs that could lead to serious side effects or injury.
Both products are produced in Brazil by Fitoterapicos, (Fytoterapicos) and Phytotherm Sim.
The FDA has increased its efforts to prevent the importation of these products into the United States.
Consumers are advised not to use the products and to return them to the suppliers.
Dr. Steven Galson, the director of the FDA’s Center for Drug Evaluation and Research, says there are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality, as the products are not approved by FDA.
He says if people experience side effects, it is difficult to trace problems and for physicians to treat them.
Although Emagrece Sim and Herbathin are marketed as "dietary supplements", but they contain the prescription drugs Librium used to relieve anxiety and to control the symptoms of alcohol withdrawal, and Prozac, used to treat depression obsessive-compulsive disorder, panic disorder, and bulimia.
The drugs may be habit forming, and can cause drowsiness and dizziness and impair the ability to drive.
Prozac 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.
The drugs should only be taken by patients under the supervision of a doctor.
The drugs were also found to contain Fenproporex, a stimulant that is not approved for marketing in the United States.
Fenproporex shows up in urinalysis as a positive test for amphetamines.
Both products are sold in packages containing one bottle of Formula 1 capsules and one bottle of Formula 2 capsules, and 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, and are also imported and distributed by Emagrece Sim Laboratories, Miami, FL., and Herbathin, Miami, Florida.
The FDA says it is aware of the commercial import of the products and individuals importing them for personal use.