Brazilian Dietary Supplements Contain Prescription Drugs, FDA Warns

Yael Waknine

Disclosures

January 13, 2006

Jan. 13, 2006 — The US Food and Drug Administration (FDA) has warned consumers against using unapproved Brazilian drug products marketed as dietary supplements for weight loss ( Emagrece Sim [also known as the Brazilian Diet Pill] and Herbathin, made by Fitoterapicos [also spelled Fytoterapicos] and Phytoterm Sim.

The products contain prescription drugs (including several controlled substances) that can cause serious adverse effects or injury when used inappropriately, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting system.

An FDA analysis has revealed the presence of ingredients such as chlordiazepoxide HCl ( Librium, made by Valeant Pharmaceuticals International) and fluoxetine HCl ( Prozac, made by Eli Lilly and Company).

Chlordiazepoxide, indicated for the relief of anxiety and the control of symptoms of alcohol withdrawal, may be habit-forming, cause drowsiness/dizziness, and impair the ability to drive.

Fluoxetine is used to treat obsessive-compulsive disorder, panic disorder, and bulimia; it has been linked to a risk for several serious drug interactions and adverse events such as increased suicidal thinking and behaviors in pediatric patients, anxiety and insomnia, and abnormal bleeding.

The products were also found to contain the illegal stimulant fenproporex, which is converted in the body to amphetamine and therefore results in individuals testing positive on urinalysis.

Emagrece Sim and Herbathin packages are available in 5 levels, each containing Formula 1 and Formula 2 capsules in separate bottles. Product labeling instructs consumers to begin with level 1 and progress through higher levels until the desired amount of weight has been lost. Emagrece Sim is also marketed as a "weight stabilizer" containing Formula 1 and Formula 2 capsules for use by consumers once they have achieved their desired weight.

According to the FDA, the products have been marketed on the Internet and have also been imported and distributed by Emagrece Sim Laboratories, Inc and Herbathin, Inc, both in Miami, Florida. Although an alert has been issued to field personnel to prevent further importation, other manufacturers and suppliers may exist.

Consumers, healthcare professionals, and caregivers are advised to cease using and dispose of these products and report related adverse events to the FDA's MedWatch reporting system by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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