FDA Says Vivus Obesity Drug Has Health Risks Before its Second Chance for Approval

Health officials are set to review for the second time Vivus Inc's prescription diet pill Qnexa that has helped overweight people lose weight but may cause long-term health problems and birth defects, the Food and Drug Administration said today.

The weight-loss drug, which FDA previously rejected in 2010 amid safety concerns like higher heart rates and memory loss in some users and potential oral clefts in infants whose mother had taken the drug during pregnancy, will be given a second chance for approval in an advisory panel hearing on Wednesday where the drug’s maker will present new data to push for its approval.

On Friday FDA had posted a review of Qnexa to its website that included two-year clinical data rather than the one-year data that had been presented in 2010.

The post also indicated that while the clinical trial participants taking Qnexa lost significantly more weight, kept weight off for longer and showed lower levels of obesity health problems like blood pressure and blood sugar compared to patients taking the placebo, the agency's endocrinologic and metabolic drugs advisory committee will be asked to vote and discuss whether the "overall benefit-risk assessment" supports the approval of the diet pill, which will most likely affect FDA’s final decision.

Qnexa, a combination of appetite suppressant phentermine and anti-seizure drug topiramate, is one of the three prescription diet pills competing to be the first to be approved in 13 years to be on the market.

Vivus had said in December that one of the drug’s ingredients, topiramate, caused a higher rate of oral clefts in infants exposed to topiramate before birth, and the drug maker had said that it would limit Qnexa to women who are not pregnant.

Vivus had resubmitted the company’s New Drug Application on October 17, 2011 proposing to limit the drug to only men and women who cannot have children, and in January, in response to an FDA request, the company extended the label and set only limited the weight loss drug from being taken by pregnant women.

A final decision by the FDA is expected on April 17, 2012.