FDA Greenlights 2nd Weight-Loss Drug

Qsymia the more effective of the pair in clinical trials
By Evann Gastaldo,  Newser Staff
Posted Jul 18, 2012 4:00 AM CDT
FDA Greenlights 2nd Weight-Loss Drug
This product image provided by Vivus Pharmaceuticals Inc. shows bottles of Qsymia, the company's anti-obesity drug.   (AP Photo/Vivus Pharmaceuticals Inc.)

After 13 years without approving a new weight-loss drug, the FDA has now approved two within three weeks. After June's approval of Belviq, the FDA yesterday approved Qsymia, which used to be called Qnexa; both drugs had previously been rejected. In studies, Qsymia resulted in the greater weight loss: Patients lost an average of 8.4% of their weight within one year when taking the middle dosage, or 10.6% on the higher dosage, compared to just 5.8% on Belviq. But Qsymia may be the riskier of the two drugs, the New York Times notes.

It raises the risk of birth defects and can cause higher heart rates and cognitive problems, so the FDA says patients' heart rates should be monitored and female patients should be on birth control and take regular pregnancy tests. Those with glaucoma or hyperthyroidism shouldn't take the drug at all, the Los Angeles Times adds. The good news: Qsymia, a combination of the appetite suppressant phentermine and epilepsy and migraine drug Topamax, has also been shown to improve blood pressure, cholesterol levels, and other heart disease predictors. It should be available later this year, and could cost around $6 per pill. (More Qsymia stories.)

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