Weight Loss Drug Heart Risks Should Be Studied Before Approval: Panel
A panel of outside advisors to the FDA has recommended that drug companies be required to prove that new weight loss medications are safe for the heart before obtaining approval from federal health regulators.
Additional clinical trials are needed to ensure obesity drugs are safe and do not increase the risk of a heart attack, according to a 17 to 6 vote last week by an FDA advisory panel.
Although the recommendations by the FDA Endocrinologic and Metabolic Drugs Advisory Committee are not binding on the agency, they are generally weighed heavily in FDA decisions.
Testimony submitted by Dr. Sidney M. Wolfe, head of Public Citizen’s Health Research Group, pointed out that there have been four obesity drug recalls over the past 15 years, including Fen-Phen, Dexatrim/Accutrim, Meridia and drugs containing ephedra. All involved an increased risk of cardiovascular events such as strokes, hypertension and heart attacks.
The vote comes as the weight loss drug Qnexa comes up for approval on April 17. Developed by Vivus Inc., if Qnexa is approved, it would be the first new weight loss pill allowed onto the market in 13 years. The last weight loss drug approved by the FDA was Roche’s Xenical, which was approved in 1999
Xenical (orlistat 120mg) is a prescription medication that was approved by the FDA in 1999. The lower dose Alli (orlistat 60mg) is an over-the-counter weight-loss drug that was approved in 2007. Both drugs are marketed by GlaxoSmithKline, PLC, though Xenical is manufactured by Roche.
The FDA issued a liver injury warning for Xenical and Alli in May 2010. Last April, Public Citizen, a consumer watchdog group, petitioned the FDA to recall Alli and Xenical from the market.