A serious warning about Brazilian Diet Pills has been issued by the [FDA] to consumers. The pills have been found to contain active drug ingredients that are found in controlled substances.
Dietary supplements are not controlled by the FDA, so regulating both ingredients and consumers for possible side effects is difficult. The Miami Herald reported three months ago about problems with the pills after three women failed pre-employment hospital drug tests after taking the nonprescription Brazilian pills. Perhaps it's time the FDA tightened its reins on so-called "dietary supplements."
Emagrece Sim Dietary Supplement and Herbathin - both known as the Brazilian Diet Pill, are sold over-the-counter and on the Internet in capsule form and are not cheap. They can cost up to $230 for a month's supply. Some users have reported losing up to 20 pounds in three weeks.
According to the FDA, the pills may contain the following:
ï¿½ Chlordiazepoxide HCl (the active ingredient in Librium)
ï¿½ Fluoxetine HCl (the active ingredient in Prozac)
Chlordiazepoxide HCl (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.
Fluoxetine HCl (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 certain serious adverse events, including suicidal thinking and behaviors in pediatric patients, anxiety and insomnia, and abnormal bleeding.
These drugs should only be taken by patients who are under the supervision of a health care provider.
Emagrece Sim and Herbathin were also found to contain a stimulant that is not approved for marketing in the United States. Fenproporex 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.
Experts attest that amphetamines can be dangerous for persons with blood pressure or heart problems, and the FDA warned that the tranquilizer Chlordiazepoxide HCl in the pills could "be habit forming, and can cause drowsiness and dizziness." The antidepressant Fluoxetine HCl "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."
"These drugs should only be taken by patients who are under the supervision of a health care provider," the FDA release said.
Both products are made in Brazil by Fitoterapicos (also spelled Fytoterapicos) and Phytotherm Sim and they are also imported and distributed by Emagrece Sim Laboratories, Inc., Miami, FL, and Herbathin, Inc. (dba EMIEX Corp), Miami, FL.
The FDA warns consumers and caregivers 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 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787; or online at [Medwatch]
LAWSUITS NEWS & LEGAL INFORMATION
Brazilian Diet Pills: you could lose more than weight
|. By Jane Mundy|
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