The FDA is warning people not to take two unapproved Brazilian drug products sold on the Internet as dietary supplements for weight loss.
The products are Emagrece Sim, also known as the "Brazilian Diet Pill," and Herbathin.
According to the FDA, the drugs contain active ingredients found in a sedative, antidepressant, and unapproved stimulant, and could cause serious health problems.
"Consumers are advised not to use the Emagrece Sim and Herbathin products and to return them to the suppliers," states the FDA, which is stepping up its efforts to prevent the drugs' U.S. importation.
"There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality," says Steven Galson, MD, MPH, in an FDA news release.
Galson directs the FDA's Center for Drug Evaluation and Research.
"These products are not approved by the FDA and if people experience side effects, it is difficult to trace problems and for physicians to treat them," Galson continues.
The two drugs are made in Brazil by Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim. There may be other makers or suppliers, and "consumers should exercise caution in using any of these imported products," according to an FDA news release.
Emagrece Sim and Herbathin are labeled as "dietary supplements" but contain prescription drugs, including several controlled substances that can be harmful if not used properly as prescribed by a doctor, says the FDA.
The Brazilian diet pills contain the active ingredients in two prescription drugs -- Librium and Prozac -- as well as an unapproved amphetamine-like stimulant, according to the FDA.
Librium is used to relieve anxiety and control symptoms of alcohol withdrawal. It is in the family of controlled substances called benzodiazepines, which also include Ativan, Xanax, and Klonopin. It may be habit forming and can cause drowsiness and dizziness and impair driving ability.
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.
Prozac and Librium "should only be taken by patients who are under the supervision of a health care provider," the FDA says.
Emagrece Sim and Herbathin also contain Fenproporex, a stimulant that's unapproved in the U.S. The body converts Fenproporex to amphetamine, which can make urine samples test positive for amphetamines, notes the FDA.
Multiple Packages, Same Problem
Emagrece Sim and Herbathin are sold in various packages, formulas, and levels. The FDA's warning applies to all versions of both products.
Report problems and side effects with these products to the FDA's MedWatch program at (800) FDA-1088 or online at www.fda.gov/medwatch/report.htm.
Sources: News release, FDA. Associated Press.
By Miranda Hitti
Reviewed by Louise Chang, MD
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