03.01.06
FDA Issues Warning about Brazilian Diet Pills
On January 13th, FDA issued a consumer warning about two unapproved drug products being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement, FDA said, may contain several active ingredients, including controlled substances found in prescription drugs that could lead to serious side effects or injury. Both products are manufactured in Brazil by Fitoterapicos and Phytotherm Sim. As a result of this incident, FDA has increased its efforts to prevent the importation of these products by issuing an alert to its field personnel.
Emagrece Sim and Herbathin contain chlordiazepoxide HCl (the active ingredient in Librium) and fluoxetine HCl (the active ingredient in Prozac). Chlordiazepoxide HCl (Librium) is used to relieve anxiety and to control the symptoms of alcohol withdrawal. Fluoxetine HCl (Prozac) is an anti-depressant medication used to treat obsessive-compulsive disorder, panic disorder and bulimia. FDA also claims that Emagrece Sim and Herbathin were found to contain Fenproporex, a stimulant that is not approved for marketing in the U.S. 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.
On January 13th, FDA issued a consumer warning about two unapproved drug products being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement, FDA said, may contain several active ingredients, including controlled substances found in prescription drugs that could lead to serious side effects or injury. Both products are manufactured in Brazil by Fitoterapicos and Phytotherm Sim. As a result of this incident, FDA has increased its efforts to prevent the importation of these products by issuing an alert to its field personnel.
Emagrece Sim and Herbathin contain chlordiazepoxide HCl (the active ingredient in Librium) and fluoxetine HCl (the active ingredient in Prozac). Chlordiazepoxide HCl (Librium) is used to relieve anxiety and to control the symptoms of alcohol withdrawal. Fluoxetine HCl (Prozac) is an anti-depressant medication used to treat obsessive-compulsive disorder, panic disorder and bulimia. FDA also claims that Emagrece Sim and Herbathin were found to contain Fenproporex, a stimulant that is not approved for marketing in the U.S. 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.