"New" Study Touting Weight-Loss Drug's Effectiveness Is Actually Old
LatestThe makers of weight-loss drug Qnexa say a new study shows how safe and effective it is. But critics say the study may not be that new — or that convincing.
Last year, the FDA withheld approval of Qnexa and requested more information about possible side effects, including “major cardiovascular events,” suicidal thoughts, and birth defects such as cleft palate. Now a study, published in Lancet and commissioned by Qnexa manufacturer Vivus, purports to offer new information about the drug’s safety and utility. Participants who took the drug along with lifestyle modifications lost an average of 18-22 pounds, compared to three pounds among those who just made lifestyle changes. CNN’s Matt Sloane writes that the study also found the drug (a combination of the medications phentermine and Topamax” to be “very safe,” although “at higher doses, some participants did complain about some psychiatric side effects.” According to the study summary, 7% of those taking the highest studied dose had “depression-related adverse events,” while 8% had “anxiety-related adverse events.” That’s compared to 4% and 3%, respectively, of controls, and it’s not clear whether any of these “adverse events” included suicidality. Nine study participants got pregnant while taking Qnexa, and none of their babies had cleft palates. Says a press release by Vivus, “QNEXA therapy was well tolerated, with no unexpected adverse events.”