It could be the first new prescription drug to treat obesity in 13 years if the Food and Drug Administration follows the advice of its advisory committee, which voted 20 to 2 this week to approve the weight-loss drug Qnexa. Obesity drugs have had a difficult time winning FDA approval; there is currently only one drug, Xenical, approved for long-term use in weight loss and its unpleasant digestive side effects make it unpopular. The FDA committee found that the potential weight loss benefits of Qnexa outweigh the potential health risks, including heart problems and birth defects. That same committee, however, voted not to recommend – and the FDA denied – approval of the drug in 2010. The difference this time, panel members said, was that some were reassured by plans to limit the health risks, like trying to make sure pregnant women did not take the drug and recommending that patients who did not lose weight after three months stop taking the medicine.
How should the FDA weigh the health risks and potential benefits of such drugs? Who should they be marketed to and is a miracle weight loss pill possible?
Dr. Abraham Thomas, chair of the FDA panel that reviewed Qnexa and division head of endocrinology at Henry Ford Hospital in Detroit
Dr. Margaret Moon, Freeman Family Scholar in Clinical Medical Ethics and assistant professor, Division of Pediatrics and Adolescent Medicine at Johns Hopkins University