For the one third of Americans over the age of 20 years old that qualify as obese, the FDA has recently approved two new drugs to help the overweight shed pounds. Belvig, which was approved in June, and Qsymia, which was approved in July, are the first drugs in 13 years to be approved by the FDA for obesity.
“Both drugs were approved for those who are obese — defined as a body mass index of 30 or above — or overweight with a BMI of at least 27 and a weight-related complication such as diabetes, high blood pressure, or high cholesterol,” said Dr. Richard Siegel of Tufts Medical Center in an interview with the Boston Globe.
Dr. Siegel also notes in the interview that “clinical trials performed by the drug manufacturers found that Belviq leads to an average drop in body weight of about 5 percent, while Qsymia leads to an average decline of 10 percent.”
While Qsymia leads to greater weight loss, it comes with a higher risk. The drug was originally rejected in 2010 due to concerns over possible adverse psychiatric and cardiovascular side effects. Vivus, the drug’s maker, sent new data that led to the FDA advisory board approving the drug in a vote of 20 to 2 in favor of the drug in February 2012. The FDA is requiring to complete 10 post-marketing studies (four more than Belviq to evaluate the drug’s long-term risk for heart attack, strokes, and other cardiovascular diseases. Patients will have to pass a screening before doctors can prescribe Qysmia.
Belviq is also not without flaw. The drug carries a risk of memory and attention disturbances. The DEA has flagged Belviq for potential drug abuse and will be subject to DEA scheduling. Even though Belziq was approved a month earlier, Belziq won’t be available until early 2013, whereas Qsymia could be on shelves by the end of the year.
Prior to the approvals of the new drugs, Xenical was the only approved prescription anti-obesity drug available in the U.S. Clinical trials have shown Xenical to have a definite, though modest effect on weight lost. Xenical users lose 2-3 pounds more per month than people not on the drug when doing the same things to lose weight.
Though Belviq and Qysmia are the first drugs in over a decade to be approved for obesity by the FDA, they are far from the first to try. Since 1997, more than half a dozen drugs have been rejected or discontinued for anti-obesity treatment. The reason for the drugs failure ranged from cardiovascular issues, links to suicide in patients, and evidence of liver damage.
With such a track record, some experts and doctors are urging caution when prescribing these new drugs.
“I think patients need to be on a short leash with any weight-loss drug,” says Dr. Siegel. “I write prescriptions for no more than three months at a time and will likely do so for these new drugs. Patients need to come in for frequent follow-up visits to see whether the medication is working and whether they’re tolerating the drug well. We don’t really know much about the safety beyond two years of use, so I wouldn’t feel comfortable keeping anyone on any drug beyond that time. “
Judy Stone is even more skeptical. In a blog on the Scientific American website, she writes, “The track record for anti-obesity drugs has not been very good—each has been withdrawn from the market, after approval, due to safety concerns. Why was this drug approved? How long will this one last before being yanked for adverse events?”
FDA Approves First Obesity Drug in 13 Years
In response to the rapid growth of national obesity, type two diabetes and high cholesterol U.S Health regulators have responded with a pill. But not just any pill. Arena Pharmaceuticals Inc will use this pill to treat obesity, making it the first weight loss drug in 13 years to be approved.