The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II which contains the unapproved drugs sibutramine and phenolphthalein. The product is marketed as a weight loss aid.
Sibutramine was removed from the market in October 2010 for safety reasons. The product poses a health threat to consumers because it can substantially increase blood pressure and pulse rate. This poses serious problems for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The drug can also interact with other medications and cause a life-threatening situation.
Phenolphthalein is an unapproved drug in the United States. Studies have shown that it presents a cancer-causing risk.
Health care professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by clicking here.
