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The 1991/1992 Weight Loss Practices Survey, sponsored by FDA and the National Heart, Lung, and Blood Institute, found that 5 percent of women and 2 percent of men trying to lose weight use diet pills. Products considered by FDA to be over-the-counter weight control drugs are primarily those containing the active ingredient phenylpropanolamine (PPA), such as Dexatrim and Acutrim. PPA is available OTC for weight control in a 75-mg controlled-release dosage form. The medicine should be used in combination with a restricted diet and exercise.

Sherman notes that FDA has received a small number of reports indicating that PPA use might be associated with an increased risk of stroke. A large-scale safety study was begun in September 1994 to explore the possibility. Based on available data, the agency does not believe that an increased risk of stroke is a concern when PPA is used at recommended dosages.
Using diet pills containing PPA will not make a big difference in the rate of weight loss, says Robert Sherman of FDA’s Office of OTC Drug Evaluation. “Even the best studies show only about a half pound greater weight loss per week using PPA combined with diet and exercise,” he adds. Sherman cautions that the recommended dosage of these pills should not be exceeded because of the risk of possible adverse effects, such as elevated blood pressure and heart palpitations.

SOURCE: Publication No. (FDA) 99-1287

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