July 17, 2012 at 7:52 PM ET
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. “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.”
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.
Qsymia is approved for use in obese adults, those with a body mass index of 30 or greater, and overweight adults, those with BMI of 27 or greater, who have at least one weight-related condition such as high-blood pressure, type 2 diabetes or high cholesterol.
This doesn’t calm the fears of Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug. Lauer and one other panelist voted against approval, but 20 panelists endorsed the drug in February.
"I believe that if the public were to 'buy' (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon," Lauer writes in Tuesday's issue of the Annals of Internal Medicine.
“If we think about the history of obesity medications, we've seen plenty of lemons. Ephedra, fen-phen, phenylpropanolamine, and sibutramine had to be withdrawn from the market because of cardiovascular toxicity. Rimonabant was approved for sale in Europe, but was never approved in the United States because of severe psychiatric side effects,” he added.
Lauer is not the only opponent. Public Citizen, a consumer group, has been campaigning against the drug, too.
"As was the case for the diet drug lorcaserin (Belviq), approved last month despite concerns about heart valve damage, it was also reckless of the Food and Drug Administration to approve Qnexa. Research shows the medication increases heart rate, and four patients on the diet pill had non-fatal heart attacks during the clinical trials, while none of those on the placebo had heart attacks," Public Citizen's Dr. Sidney Wolfe said in a statement.
"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."
Vivus hopes it will be a safer successor to the notorious and now banned “fen-phen” diet cocktail. Fen-phen combined fenfluramine and phentermine -- one of the two drugs in Qsymia -- but it damaged the heart in some cases and caused a condition in some patients called pulmonary hypertension, which causes fluid to build up in the chest, bringing a feeling of breathlessness.
Reviewers say the amount of the drug phentermine in Qsymia is safer. The two drugs together seem to lower appetite while keeping patients perky. Lauer said he would have liked to see more tests to specifically look for heart problems before the FDA approves the drug.
Doctors tested the pill in more than 4,430 overweight and obese patients. About half lost 10 percent of their weight -- enough to lower cholesterol and blood pressure, reduce the risk of diabetes and early death.
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