June 11th, 2010
FDA Announces Ongoing Safety Review of Olmesartan
Larry Husten, PHD
The FDA announced an ongoing safety review of olmesartan (Benicar). The agency said it “has not concluded that Benicar increases the risk of death” and advises patients and healthcare professionals that it “currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.” The review was prompted by unexpected findings in the ROADMAP and ORIENT clinical trials of an increased number of cardiovascular deaths in patients taking olmesartan compared to placebo.
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