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Meg Evans, in red, lost 48 pounds her first year on Qsymia and another two pounds the second year.

STORY HIGHLIGHTS

(CNN) -- The U.S. Food and Drug Administration approved a new prescription diet drug called Qsymia on Tuesday. The medication produced dramatic weight loss in clinical trials, but some are concerned over potential side effects, including increased heart rate, birth defects and other issues.

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.

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.

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.

Some consumer advocates worry that the 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. Qsymia's other ingredient is phentermine, an appetite suppressant.

"Our belief is that women will be invited to 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 2 diabetes.

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FDA to approve new diet drug

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