Rather surprisingly, an FDA panel has voted against approval of the proposed weight –loss drug Qnexa.
The vote, taken yesterday, was narrowly lost by 9 to 7. The panel said that though they believed that Qnexa was effective, they were worried about granting approval before several key safety concerns are resolved.
The panel agreed that the new medication does work better than any currently approved weight loss drug, enabling users to lose up to 14.7% of their body weight when used in conjunction with a diet and exercise program.
However they were concerned that the medication could potentially cause a series of side effects, including birth defects, an increased suicide risk and an increased risk of kidney stones.
Qnexa uses two medications which are already on the market, phentermine and the seizure drug topimirate. While both medications are approved separately, it seems that the panel were disturbed by how many people were projected to want to try the medication. Millions in America are obese and a large number of those are likely to want to try a new slimming pill, were it to be available.
The panel said that as the clinical trials lasted for only a year, it was ‘impossible to extrapolate the trial data to the wider population’, according to panel chair Kenneth Burman of Georgetown University.
While the FDA does usually follow the advice of their panel when deciding whether or not to grant approval for a new medication, they are not obliged to do so. The closeness of the vote made FDA Deputy Director of Endocrine Products, Eric Coleman, say in a news conference that there was a sense that a lot of people were hesitant over whether or not to give the drug the go-ahead.