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FDA notified consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement but containing sibutramine, an undeclared drug product and a controlled substance with risks for abuse or addiction. When present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate, and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke. The product was sold via distributors and in retail stores nationwide and was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743. Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects.
Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Venom
You are encouraged to report all serious adverse events and product quality problems for human medical products to MedWatch at: www.fda.gov/medwatch/report.htm.
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