Qsymia, a new diet drug just approved by the U.S. Food & Drug Administration (FDA), is already raising serious concerns regarding its safety. According to a report from WebMD, Qsymia’s label will include a warning regarding its association with oral birth defects, such as cleft lip and cleft palate.
Qsymia is a combination of the stimulant phentermine and the anti-seizure drug Topamax. Fetal exposure to Topamax has been linked to an increased risk for cleft lip, with or without cleft palate. According to WebMD, women considering Qsymia will be advised to use effective birth control while on the drug. Pregnancy tests prior to starting the medication, as well as monthly screenings, are also recommended. Topamax has been shown to decrease the effectiveness of birth control pills, so women taking Qsymia should probably consider other methods.
Phentermine was also used in an earlier diet pill called fen-phen, which in 1990s was found to cause serious heart valve problems. Phentermine is known to cause heart palpitations.
According to WebMD, the FDA refused to approve Qsymia back in 2010, citing an increased risk of heart attack and stroke. At the time, the drug was to be called Qnexa, but the FDA had Vivus change the name due to concerns that it sounded too similar to other widely used drugs. Qsymia’s label will state it is not recommended for people who have had a heart attack or stroke, and that it should not be used in people with glaucoma or hyperthyroidism. Qsymia will only be dispensed through specially certified mail-order pharmacies.
Despite these precautions, some patient advocates are unhappy with the FDA’s decision to approve Qsymia. A statement issued by the group Public Citizen called the FDA’s approval of Qsymia “reckless,” citing other diet drugs that have been recalled due to safety concerns, including fen-phen and Meridia.
“In the case of (Qsymia), this is the second time that a company has sought to combine (the stimulant) phentermine with another drug,” Sidney Wolfe, PhD, director of health research for the consumer group Public Citizen, said in the statement. “The first time was fen-phen.”
“It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system,” he continued.
As part of the Qsymia approval, the FDA ordered Vivus must conduct 10 post- market studies, including a long-term trial to assess the risk for cardiac events such as heart attack and stroke.