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FDA Warns About Weight Loss Products
Date:12/22/2008

ical experiments and a suspected cancer-causing agent). Some of the amounts of active ingredients greatly exceed FDA-recommended levels, putting consumers' health at risk, the agency said.

The risks posed by these products can be serious, the FDA said. For instance, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, palpitations, heart attack or stroke. The drug can also interact with other medications that patients may be taking and increase their risk of serious side effects. The safety of sibutramine also hasn't been determined for women who are pregnant or breast-feeding, or in children younger than 16 years of age, the agency said.

Rimonabant was evaluated -- but not approved -- by the FDA for marketing in the United States. The drug, which has been approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe during the last two years, the agency said in the news release.

Consumers who have used any of these products should stop taking them immediately and consult their health-care professional. And consumers should always seek the guidance of a health-care professional before purchasing weight loss products, the FDA said.

The FDA said it has inspected a number of companies linked to the sale of these products, and is currently seeking to have the products recalled. Citing its own inspections and what it called the companies' "inadequate responses to recall requests," the agency said it may take additional action, including issuing warning letters or seeking criminal charges.

Health care professionals and consumers should report serious side effects or product quality problems to the FDA's MedWatch Adverse Event Reporting program. The e-mail address is www.fda.gov/MedWatch/report.htm. Or call (800) FDA-1088 or Fax (800) FDA-0178.

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