WASHINGTON, Feb. 17 (UPI) -- Documents released by the U.S. Food and Drug Administration indicate it has concerns the weight-loss drug Qnexa might cause birth defects and heart problems.
The drug, a combination of two existing drugs -- the stimulant phentermine and the epilepsy and migraine drug topiramate, developed by Vivus -- was rejected by the FDA in 2010 for the same reasons the FDA points out, and a committee of outside advisers is scheduled to meet Wednesday to consider the drug again, The New York Times reported.
One question the panel is scheduled to consider before the drug can be approved is whether Vivus should be required to conduct a large new clinical trial to assess whether the drug increases the risk of heart attack. Because the trial could delay approval by years, Vivus has proposed doing the study after the drug is approved.
The most recent studies show topiramate used during pregnancy increases the risk of oral clefts, such as cleft lip, by a factor of two to five, the FDA staff review said.
Some are advocating for the drug because they said there is a strong need for new obesity drugs, but the FDA review warned with two-thirds of U.S. adults overweight or obese, the anti-obesity drugs might be used for a long time by millions of people.
Qnexa appeared to help people lose weight but in the second year of one clinical trial, patients regained roughly 10 percent to 20 percent of the weight they had lost in the first year, the Times said.