FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Alerts Consumers to Avoid Weight Loss Product

Dec. 10, 2015

The FDA is advising consumers not to purchase or use Lipo Escultura, a weight loss product manufactured by Brooklyn, N.Y.-based JAT Productos Naturales.

A laboratory analysis of the product confirmed the presence of sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons, as it has been linked to increased blood pressure or pulse rate in some patients. It may pose a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

The product also was found to contain diclofenac, a nonsteroidal anti-inflammatory drug, which may cause increased risk of cardiovascular events and serious gastrointestinal damage.