New diet drug Qsymia may be rejected by European drug regulators

bathroom scale iStock CROPPED New diet drug Qsymia may be rejected by European drug regulatorsQsymia, first diet drug to be approved in 13 years by the U.S. Food and Drug Administration (FDA), may not get clearance from the European Medicines Agency because of the potential for heart problems. A European Union advisory panel is expected to rule on the weight loss treatment sometime next month, but the drug’s maker Vivus Inc. says it has been getting some cold vibes from the group. If rejected, Vivus says it will file a new marketing application or appeal the decision. Vivus wants to market Qsymia in Europe under the name Qsiva.

This summer, the FDA approved Qsymia and Arena Pharmaceutical Inc.’s diet drug Belviq. Qsymia hit the market last week, but Belviq isn’t expected to go on sale until early 2013. Qsymia is generally considered to be more effective than Belviq. Both drugs are considered lifelong treatments to help overweight and obese people manage their weight.

The concern about Qsymia for the European Medicines Agency involves one of the drug’s two active ingredients – phentermine, a stimulant that acts as an appetite suppressant. Phentermine was part of the fen-phen diet drug cocktail that was popular in the 1990s but pulled from the market after the medication’s other active ingredient, fenfluramine, was linked to heart valve damage.

The makers of Qsymia and Belviq are required to perform long-term trials to examine the risk for heart attacks and strokes.

Qsymia’s other ingredient is topiramate, a drug used to treat seizures. During its review of Qsymia, the FDA raised concerns about the birth defect risks associated with topiramate. Women who are prescribed Qsymia are advised to use reliable forms of birth control.

Source: PharmPro