CardioExchange Archive

June 25th, 2014

FDA Completes Safety Review of Olmesartan

Larry Husten, PHD

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 […]

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July 4th, 2013

FDA: Olmesartan Can Cause Sprue-Like Enteropathy

Larry Husten, PHD

The FDA is warning that the angiotensin II receptor blocker olmesartan (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe diarrhea. According to an FDA safety announcement, olmesartan “can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.” The warning is being added […]

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April 15th, 2011

FDA Offers Cautious Support for Olmesartan (Benicar)

Larry Husten, PHD

The FDA announced on Thursday that it had reviewed the results of the ROADMAP and ORIENT trials and had determined that the benefits of olmesartan (Benicar, Daiichi Sankyo) “continue to outweigh its potential risks” when used as indicated for the treatment of high blood pressure. In June 2010 the FDA had announced that it was […]

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March 10th, 2011

Olmesartan Helps Prevent Microalbuminuria, But a Troubling Question Persists

Larry Husten, PHD

Olmesartan can help prevent progression to microalbuminuria in type 2 diabetics, according to results of the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) trial published in the New England Journal of Medicine. But the positive result was partially offset by the troubling finding of a small but significant increase in fatal cardiovascular events. Type 2 diabetics […]

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