If Qnexa gets the green light, who would get the drug?
An advisory committee’s hearty 20-to-2 vote to recommend approval of the obesity drug Qnexa on Wednesday means it’s highly likely the FDA will allow the medication to be marketed when the agency issues its final report later this year. If approved, Qnexa will be the first new prescription weight-loss medication in 13 years.
But people looking for a quick way to lose five or 10 pounds may find Qnexa too troublesome to bother with. According to the manufacturer of the medication, Vivus Inc., and FDA officials, Qnexa should be carefully prescribed and patients should be closely monitored while on the drug.
Qnexa, a combination of the anticonvulsant topiramate and the appetite suppressant phentermine, produces an average 10% loss in body weight after one year. Many people with hypertension also see improvement in blood pressure. But the drug increases the risk of cleft lip in babies whose mothers became pregnant while taking it. Studies also show Qnexa increases heart rate, which can result in cardiovascular problems.
If approved, Qnexa users would likely have to order the drug through mail-order pharmacies, a strategy to limit easy access, such as by online purchasing. Women of childbearing age would likely be required to take a monthly pregnancy test. Moreover, the drug is expected to be labeled for people with a body mass index of 30 or above or a BMI of 27 or above for people who also have weight-related health problems, such as diabetes. A BMI of 25 to 29 indicates being overweight and 30 or greater is considered being obese.
Dr. Elaine H. Morrato, assistant professor of health systems, management and policy at the University of Colorado, Denver, said she voted against approval of Qnexa in 2010 but decided to recommend approval this time because of the safeguards that will be put in place to monitor appropriate use and prevent problems.
“I believe the FDA and the sponsor are striving to find the right balance between access to effective anti-obesity medications and the corresponding risks,” she said.
People who don’t lose weight after three months on the drug would be encouraged to discontinue use because of its potential risks, experts said Wednesday. It’s likely that the first doctors to prescribe the medication would be those who specialize in obesity.
Qnexa should not be viewed as a quick fix for a trivial problem, said Joe Nadglowski, president of Obesity Action Coalition, a patient advocacy group.
“In the right hands, in the right patients, obesity drugs are an important part of the formula,” he said.
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