The U.S. Food and Drug Administration approved the new weight loss pill Qsymia on Tuesday, adding to a very skimpy arsenal of drugs Americans can take to battle severe obesity -- and adding a last-minute name change after two years of wrangling over whether to approve the drug.
Qsymia (pronounced kew-SIM-ee-ah) pairs an old stimulant drug with an epilepsy drug to try and bring some options to the two-thirds of Americans who are overweight or obese -- and who have higher rates of heart disease, diabetes, stroke and cancer as a result.
“Obesity threatens the overall wellbeing of patients and is a major public health concern,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
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“Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
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It’s the second obesity drug to win FDA approval this summer. Last month, the agency OK'd Belviq, the first new weight loss drug approved in 13 years. Qsymia combines phentermine, a stimulant, with the anti-seizure drug topiramate.
The FDA took its time in reviewing Qsymia, formerly known as Qnexa, because of fears about the side-effects, which can include a fast heart rate and metabolic acidosis, a condition marked by highly acidic blood that can, in severe cases, put people into a coma and even kill them. Metabolic acidosis can also cause kidney stones and damage bones. There’s been a growing debate over whether it’s worth the risk of taking drugs that could damage the heart to battle the growing obesity epidemic.
Diet drugs have a sketchy history in the U.S. and the FDA worries about irresponsible doctors who dispense pills from their offices to just about all comers, whether they’re in the group that’s supposed to get the drug or not. The FDA approves drugs for certain uses in certain people, but once a drug is approved, a licensed doctor may prescribe it as he or she sees fit.
Vivus, the company that makes the drug, has said it’s aware of this and has said it would restrict who can prescribe Qsymia and how. The once-a-day pill will be available only through mail order so that doctors cannot dispense it from their offices. The company also plans to educate doctors about the drug's risks, which include birth defects, and to carefully watch users for any signs of heart damage.
The agency asked for a last-minute name change from Qnexa, however. "The FDA indicated concern about potential confusion regarding the name Qnexa and worked with Vivus during the final steps of the review process to identify Qsymia as an acceptable brand name," Vivus's Dr. Barbara Troupin said in a statement.
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