FDA warns 2 Brazilian diet pills contain amphetamines

January 13, 2006 - 7:40pm

MIAMI - The Food and Drug Administration warned consumers Friday not to use two brands of popular Brazilian diet pills imported and distributed by Miami firms because they "could lead to serious side effects or injury."

The agency said dieters should avoid Emagrece Sim and Herbathin, expensive over-the-counter pills that "contain several active ingredients, including controlled substances, found in prescription drugs," the FDA said in a press release.

As The Herald had previously reported, the FDA confirmed on Friday the pills contain a type of amphetamine as well as tranquilizers (the generic for Librium) and antidepressants (generic Prozac).

All three drug types require a prescription in the United States, and amphetamines are classified as a controlled substance because they have addictive qualities.

"Wow, I got goose bumps," said Thomas Moore, a Baptist Health human resources staffer when he heard the news. The Miami Herald reported three months ago about problems with the pills after Moore said three women failed pre-employment hospital drug tests after taking the nonprescription Brazilian pills. "It's really appropriate the FDA acted."

The FDA said the two brands of pills are made in Brazil by Fitoterapicos and Phytotherm Sim, which may be two names for the same company.

The firms have been assisted in drug exporting by Brazil's central bank, which has helped train its managers, pushed its products on the bank's Web site and even shown the drug maker how to get a tax break on the raw materials for Emagrece Sim, according to the Web site of Banco do Brasil.

Mitchell Fuerst, a Miami attorney representing Fitoterapicos, was not immediately available for comment.

Fernando DaSilva, Herbathin's manager, said the company discovered a shipment imported from Fitoterapicos in October had problem substances and Herbathin hasn't distributed any of those pills. He said Herbathin has broken off relations with the Brazilian drug maker and is now working with an American manufacturer to make a new batch under a formula acceptable to the FDA.

The Brazilian pills, often sold over the Internet, can cost up to $230 for a month's supply. Some users say they lost up to 20 pounds in three weeks.

The FDA reported Emagrece Sim and Herbathin contain "Fenproporex, 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."

On the Brazilian central bank Web site, it was reported that Fitoterapicos sold the pills only outside the country and used a virtual showroom on the Web site to sell its product.

Before using the virtual showroom, the drug maker had many problems with customers, Claudina Bonfim of Fitoterapicos said on the Web site. "After using this product, the problem was solved."

The Web site also reported the company participated in periodic training sessions offered by the bank. "In one of those it discovered it could benefit from an import tax exemption applied to products used in making Emagrece Sim," the Web site states, adding that the bank's exterior relations department "helped the company in every operation."

Several Miami residents have complained that they lost jobs because they tested positive for amphetamines after taking Brazilian diet pills, and a U.S. Customs employee was suspended for seven months before Miami toxicologist Terry Hall explained to the agency about the hidden substances in the diet pills, which claim to have "all-natural ingredients."

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

Amphetamines can be dangerous for persons with blood pressure or heart problems, experts say, and the FDA warned Friday that the tranquilizer in the pills could "be habit forming, and can cause drowsiness and dizziness." The antidepressant "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.

The agency said it had issued orders to block Emagrece Sim and Herbathin from being imported into the United States. It advised consumers that if they had already purchased Emagrece Sim or Herbathin products, they should return them to suppliers.

The FDA said the products were imported and distributed by two Miami companies, Emagrece Sim Laboratories and Herbathin, doing business as EMIEX Inc. "There may be other manufacturers or suppliers of imported Emagrece Sim and Herbathin, and consumers should exercise caution in using any of these imported products," the agency said.

A person who answered the phone at Fitoterapicos' Brazilian office said the person who could comment had left for the day, but on the central bank's Web site, a spokeswoman for the firm stated, "With the knowledge we're getting from the Banco do Brasil training and consulting department, we can foresee a solid and prosperous future for our company."

However, on Friday afternoon, the bank's virtual showroom no longer had a display for Emagrece Sim.

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(Miami Herald staff writer Alejandra Labanca contributed to this report.)