When Will Daiichi Sankyo And FDA Report On Additional Studies And Analyses Of Clinical Studies About Cardiovascular Mortality Increased Risks Of Benicar
In June 2010 the FDA issued a Drug Safety Communication letting doctors and patients know that two clinical studies found that patients with Type 2 diabetes taking Benicar had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.
Three years later this Benicar (olmesartan) FDA safety review is still ongoing.
Benicar -- as well as Benicar HCT, Azor, and Tribenzor -- is an angiotensin II receptor blocker (ARB) used as a blood pressure medication. The drug company Daiichi Sankyo makes Benicar.
There was an April 2011 interim report about this cardiovascular mortality aspect of Benicar's safety profile issued by the FDA:
This safety review update is in follow-up to the FDA Drug Safety Communication: Ongoing Safety Review of Benicar (olmesartan) and cardiovascular events on 6/11/2010.
After reviewing the results of the ROADMAP and ORIENT trials, FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label....
Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings. FDA will update the public when new information is available.
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Now, more than two years after that latest FDA update about the cardiovascular side effects of Benicar -- not to be confused with the intestinal side effects such as severe diarrhea and sprue-like enteropathy -- one wonders when we will hear back from Daiichi Sankyo and the FDA on those additional studies and analyses of clinical studies about the cardiovascular risks of Benicar.
In the meanwhile, we will watch for new medical journal articles about any statistical and clinically significant increase in cardiovascular mortality associated with Benicar.