Laboratory analysis by the U.S. Food and Drug Administration found the products contained undeclared Sibutramine or a combination of both sibutramine and phenolphthalein. Sibutramine, a previously approved controlled substance, was removed by the U.S. market in 2010 because of concerns it increases the risk of heart attacks and strokes in patients with a history of cardiovascular disease.
Phenophthalein is used medicinally as a laxative and not approved for marketing in the United States. These products, marketed as dietary supplements for weight loss, are unapproved new drugs, the FDA said.
"Products containing sibutramine and phenophthalein pose a threat to consumers because sibutramine can increase blood pressure and/or pulse rate in some patients and might present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking," the FDA said.
To date, the company has not received any reports of adverse events related to this recall. The recall was initiated after discovering the sibutramine and phenophthalein were included as ingredients by the manufacturer.
Adverse reactions or problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program at: www.fda.gov/medwatch/report.htm; or call 1-800-332-1088 to request a reporting form.
Consumers with questions can contact Pure Edge Nutrition, LLC at 1-888-417-3613 Monday to Friday 10 a.m. to 2:00 p.m.