Warning: Brazilian Diet Pills Found to Contain Active Drug Ingredients

January 19, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Warning: Brazilian Diet Pills Found to Contain Active Drug Ingredients

The US Food and Drug Administration (Rockville, MD, www.fda.gov) issued a warning on Jan. 17 advising users of the "Emagrece Sim" dietary supplement, also known as the "Brazilian Diet Pill," and the "Herbathin" dietary supplement to stop taking the product immediately.

According to FDA, the two unapproved drugs may contain several prescription-only active ingredients, including chlordiazepoxide HCl (the active ingredient in "Librium"), and fluoxetine HCl (the active ingredient in "Prozac"). The supplements may also contain Fenproporex, an amphetamine pro-drug that is not approved in the United States.

"There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality," said Steven Galson, director of FDA’s Center for Drug Evaluation and Research in a release. "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."

Both drugs are being imported from Brazil-based manufacturers Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim, and are available in multi-stage weight-loss pills. Side effects include, drowsiness, dizziness, and the potential for addiction.

Consumers, healthcare providers, and caregivers are asked 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 800.332.1088 or fax at 800.332.0178.