The Food and Drug Administration (FDA) is warning consumers not to buy or use ZeroXtreme Capsules and Akttive Capsules, supplements marketed for weight loss, due to the presence of undeclared ingredients.

An FDA analysis determined that ZeroXtreme Capsules contained sibutramine, a controlled substance that was withdrawn from the market in October 2010 due to safety reasons. It may increase blood pressure and/or pulse rate in some patients. In particular, patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke may be at an increased risk. It was also found to contain desmethylsibutramine, a structurally similar substance to sibutramine.

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Akttive Capsules were also found to contain sibutramine, plus desmethylsibutramine and phenolphthalein. Desmethylsibutramine is a substance structurally similar to sibutramine. Phenolphthalein is a chemical that is not found in any approved drug in the United States. It may present a risk of cancer and may interact with other medications a consumer is taking.

Healthcare professionals and consumers are encouraged to report to the FDA’s MedWatch Adverse Event Reporting program any adverse events or side effects potentially related to use of these products. These products are sold online and in some retail stores.

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