FDA Approves Vivus’ Obesity Drug, Recommends Against Use In High-Risk Heart Patients

A Risk Evaluation and Mitigation Strategy for Qsymia includes prescriber education about the risk of birth defects and limits dispensing to specially certified pharmacies

FDA approved Vivus Inc.’s weight management drug Qsymia July 17 but is recommending the phentermine/topiramate combination not be used in patients with recent (within the last six months) or unstable heart disease or stroke.

Cardiovascular safety has been behind much of the delay on the trio of obesity drugs that have been attempting to...

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