FDA Completes Safety Review of Olmesartan — Physician’s First Watch
FDA Completes Safety Review of Olmesartan
By Larry Husten
The FDA announced on Tuesday that it has completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and others). 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 agency says it will not change the recommendations for olmesartan's use but will include new data about the drug in its label.