Qnexa to be Reviewed Again by FDA
A diet treatment that combines two medications some doctors already prescribe together and may lead to an increased risk of birth defects and cardiovascular problems is going to be reviewed for approval by the Food and Drug Administration,
Qnexa - which is produced by Vivus and essentially consists of a combination of the stimulant phentermine and topiramate - was initially denied approval by the FDA in October 2010 amid safety concerns that it could lead to an increased risk of birth defects in women who take it.
However, The New York Times reports the denial has not stopped consumers from essentially receiving the drug, as some doctors have been prescribing both drugs together to patients looking to minimize their appetite.
Dr. Christopher D. Still, the director of the obesity institute at Geisinger Health System, estimated that 70 percent of obesity specialists had prescribed the combination, despite the birth injury risk associated with Qnexa
Due in part to the off-label prescriptions, the FDA announced that an advisory panel will once again review Qnexa this week and make recommendations regarding a potential clinical trial to test its risks. Only after a clinical trial could the drug once again be considered for FDA approval.
Topiramate, one of the two drugs that make up Qnexa, is better known as the anti-seizure medication Topamax. An increased risk of orofacial birth defects, including cleft lip and cleft palate, has also been attributed to children who are born to mothers who are used the medication as well. If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law today to learn more about pursuing a dangerous drug lawsuit.