FDA Warns of More ‘Supplements' Containing Hidden Drug Ingredients

Due to the presence of undeclared drug ingredients, FDA is warning consumers not to purchase or use certain products marketed as dietary supplements, including Slim Vie, Super Extreme Accelerator, and Black Storm.

• Slim Vie and Super Extreme Accelerator contain sibutramine, a controlled substance that was removed from the market in October 2010 due to safety concerns. Sibutramine may substantially increase blood pressure and/or pulse rate in some patients, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
• Black Storm contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra^®, used to treat erectile dysfunction. The drug may interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.

In addition, undeclared drug ingredients may cause serious side effects when combined with other medications. Health care providers and patients are encouraged to report any adverse events or side effects related to the use of these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The FDA consumer information sheet “Tainted Products Marketed as Dietary Supplements,” (PDF) includes a list of the potential warning signs of products marketed as dietary supplements that contain undeclared or deceptively labeled ingredients.