US FDA issued a safety announcement on 24th June, 2014 after completion of safety review of Olmesartan. No clear evidence of increased cardiovascular risks was found with use of olmesartan among diabetic patients. Thus, the recommendations for use of Olmesartan will remain, with the addition of results of some studies on drug labels.
This safety announcement follows the earlier two announcements made by US FDA, first in year 2010 and second one in year 2011.
ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) trial had examined the effects of olmesartan in patients with type 2 diabetes and whether olmesartan could delay kidney damage. Unexpectedly, there was an increased risk of cardiovascular deaths in olmesartan group as compared to placebo group. But, the risk of non fatal heart attack was less in the olmesartan group. At that time, no conclusion was made regarding the risks of death. The announcement mentioned about the ongoing safety review about use of olmesartan.
In April 2011, US FDA issued a safety review update specifying that the benefits of olmesartan use continue to outweigh its potential risks when used among hypertensive patients. Olmesartan is not recommended for delay or prevention of microalbuminuria among diabetic patients.
