FDA panel recommends approval of controversial diet drug Qnexa
A new diet drug may soon be available for people battling the bulge, but it may come at a price. This week, a Food and Drug Administration (FDA) advisory panel reviewed clinical data on the weight loss drug Qnexa and voted to recommend its approval despite rejecting its application a year ago due to serious health concerns. The FDA is expected to make a final ruling about the drug later this year, but the agency typically follows the recommendations of its advisory panels. If approved, Qnexa will be the first prescription diet pill to hit the United States market since 1999.
Qnexa is a combination of two already approved drugs – the anticonvulsant drug tropiramate and the appetite suppressant phentermine. Concerns were originally raised because tropiramate has been linked to birth defects; and phentermine, the “less dangerous” part of the now-banned Fen-Phen cocktail, has been linked to heart problems. Previous data wasn’t thorough enough to satisfy regulators.
The new data, pulled from a clinical trial of 4,323 people, found that Qnexa led to an average loss of about 10 percent of total body weight in the first year, and that many users also saw an improvement in blood pressure. But the data also showed a slight heart rate increase, which could increase the risk for heart attack or stroke. Women who took the drug and became pregnant – which several in the trial did – also had an increased risk of delivering a baby with cleft lip.
Drug maker Vivus Inc., suggested tempering the birth defects risk by recommending that women who are prescribed the drug undergo monthly pregnancy testing. The company also proposed a similar program to monitor heart risk in patients. While the advisory panel approved the drug, it did also stress that the company conduct a post-marketing study to help identify the potential cardiovascular risks.
Source: LA Times