FDA Advisors Vote for Qnexa
Posted: June 19, 2012
An FDA advisory panel voted 20-2 to endorse the new weight loss pill Qnexa. The FDA will issue a final ruling later this year, but the agency typically follows the recommendations of its advisory committees. The 20-2 vote in support of Qnexa was a startling turnaround from 2010, when the same advisory committee decided that the drug’s risks of heart problems and birth defects outweighed its weight-loss benefits.
In a clinical trial involving 4,323 people, Qnexa — a mixture of the anticonvulsant drug topiramate and the appetite suppressant phentermine — led to an regular loss of about 10% of total body weight in the first year of use. Many users also saw improvements in blood pressure.
But the trials also found that that the drug caused a small boost in heart rate, which can heighten the odds of a heart attack or stroke. In addition, researchers detected an augmented risk of birth defects — typically cleft lip — in women who became pregnant while taking the drug.
Vivus Inc., the drug’s producer, addressed those concerns by proposing a closely controlled system for prescribing Qnexa. To prevent birth defects, patients who take the drug will have to undergo monthly pregnancy testing and healthcare providers will get special training on the medication’s risks and benefits. Vivus will also limit distribution of the drug to registered pharmacies, along with additional actions.