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FDA announces ongoing safety review of olmesartan
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The FDA is evaluating data from two clinical trials in which patients with type 2 diabetes assigned olmesartan, an angiotensin II receptor blocker, had a higher rate for death from a CV cause when compared with patients assigned placebo. As of press time, the FDA’s review is ongoing, and officials have not determined whether the drug increases the risk for death.
The FDA currently states that the benefits of olmesartan (Benicar, Daiichi Sankyo) in patients with increased BP outweigh the potential risks.
Officials are considering additional ways to assess the CV effects of olmesartan and are currently reviewing primary data from Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study and Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT) — the two trials of concern.
In both trials, patients with type 2 diabetes were assigned olmesartan or placebo to determine whether treatment would slow the progression of kidney disease. Researchers unexpectedly identified an increased mortality rate from a CV cause, such as an acute MI, sudden death or stroke, among those assigned olmesartan vs. those assigned placebo.
The FDA said health care professionals should follow the recommendations located on the drug label when prescribing olmesartan. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Additional information about ROADMAP and ORIENT can be found at clinicaltrials.gov.
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