FDA-approved diet drug Qsymia now available with prescription
Style News Wire | 9/19/2012, 10:43 p.m.
A new diet drug approved by the U.S. Food and Drug Administration in July is now available for obese and at-risk overweight patients. The oral medication Qsymia can only be obtained with a doctor's prescription.
Qsymia (pronounced kyoo-SIM-ee-uh) is the second diet drug approved this year. The FDA approved a weight-loss pill called Belviq on June 27.
Patients in clinical trials experienced more dramatic weight loss with Qsymia than with Belviq. On Qsymia, patients went from an average 227 pounds to 204 pounds; on Belviq, the average weight dropped from 220 to 207.
Qsymia had been known as Qnexa until its approval. The FDA asked the company to change the name to avoid confusion with another drug on the market, according to the company.
Concerns have also been raised about birth defects. One of the ingredients in Qsymia is topiramate, an anti-convulsant that has been linked to birth defects such as cleft lip and cleft palate in babies born to women who have taken it for migraines or seizures. Qsymia's other ingredient is phentermine, an appetite suppressant.
"Our belief is that women will be invited (through) compelling advertising and marketing messages to experiment on themselves with a drug that has some effectiveness with healthy weight loss but possible serious risks," said Cindy Pearson, executive director of the National Women's Health Network.
Qsymia's manufacturer, Vivus Inc., says that the drug helped lower blood pressure and cholesterol levels in obese people and that people taking it were less likely to get type II diabetes.
"Obesity is not being adequately addressed by diet and lifestyle changes or currently available therapies," the company said. "The need for new options is urgent, particularly nonsurgical options."
The FDA approved Qsymia only for obese people or for overweight people with a body mass index greater than 27 who also suffer from weight-related conditions like hypertension and diabetes.
Doctors are free to prescribe the drug to anyone, however, and there are concerns that physicians will open "pill mills" and prescribe Qsymia to people who just want to lose a few pounds. That's what happened in the 1990s with fen-phen, another diet drug combination that includes phentermine.
An FDA advisory committee voted against Qsymia's approval in 2010. The panel recommended the drug's approval with a 20-2 vote in February, after Vivus proposed a risk management program to limit Qsymia's distribution and published additional results from one of its three clinical trials.
Vivus is offering the pill only through mail order, so doctors can't sell it directly, said Dr. Barbara Troupin, Vivus' vice president of scientific communications and risk management.
"There will not be dispensing from doctors' offices," she said. "Seeing that issue and what has happened in fad and diet drugs in the past, that is not a path that we're going to be taking."
The 4,430 overweight and obese patients in the Qsymia studies experienced various levels of weight loss. About half of patients on the recommended dose lost 10% of their weight, while four-fifths lost 5%. That amounts to about 12 pounds for a 227-pound person.