FDA Approves New Weight-Loss Drug Qsymia

A new weight-loss drug has won approval from federal regulators for the first time in more than a decade.

The drug, called Qsymia (phentermine and topiramate extended release), was approved by the U.S. Food and Drug Administration (FDA) as an addition to a reduced-calorie diet and exercise for chronic weight management.

The drug is approved for use in adults with a body mass index (BMI) of 30 or more, or adults with a BMI of 27 or more who have one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia), according to an FDA press release.

It is a combination of two FDA-approved drugs, phentermine and topiramate (Topamax), in an extended release formulation. Phentermine is indicated for short-term weight loss in overweight people or obese adults.

The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a medication guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification.

The drug’s marketer, Vivus Inc., will be required to conduct 10 post marketing requirements, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.

The most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you. For legal help, call (800) 581-6358.

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