June 25th, 2014

FDA Completes Safety Review of Olmesartan

The FDA announced on Tuesday that it had completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when results from the ROADMAP trial showed that patients with type 2 diabetes taking olmesartan had an increased risk for cardiovascular death.

Now the FDA says that it “has found no clear evidence of increased cardiovascular risks associated” with olmesartan in diabetic patients. The FDA said that it would not change the recommendations for the use of olmesartan but it will include new data about the drug in its label.

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