Posted on: 10:36 am, September 18, 2012, by Ryan Sullivan, updated on: 09:00pm, September 18, 2012
(CNN) 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 doctors 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.
Some consumer advocates worry that the medications weight loss comes with a price. Some patients in the clinical trial suffered an increased heart rate and a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia.
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. Qsymias 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 Womens Health Network.
Qsymias 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.
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Diet drug Qsymia approved by FDA
