Benicar, Azor, Tribenzor, Benicar HCT, And Other Blood Pressure Medicines Containing Olmesartan: Cardiovascular Mortality In Not A Side Effect Risk, Or Is It
UPDATE: "FDA Once Again Reaches Conclusions At Odds With Its Own Staff" (Forbes, Larry Husten, 7/14/14)
Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists. Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug....
UPDATE: Recent Benicar label change according to the June 13, 2014 FDA Letter:
Under ADVERSE REACTIONS/Post-Marketing Experience, the following test [sic] was added:
Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive....
Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.
In June 2014 FDA announced that the agency had completed its safety review of Benicar, Azor, Tribenzor, and Benicar HCT, finding no clear evidence of increased cardiovascular risks associated with use of these blood pressure medication containing olmesartan in diabetic patients.
Four years earlier, 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.
So does this mean that Benicar is not associated with cardiovascular-related deaths, at all?
From the very title of this June 2014 announcement, "FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required", one does not get much assurance that this conclusion is tried and true.
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Moreover, a well-regarded medical journalist covering cardiology news, Larry Husten, takes issue with that conclusion in his June 24, 2014 article "FDA Ends Olmesartan Safety Review, But...".
From this article, which was posted by Forbes magazine on its website:
A careful reading of the FDA announcement, however, suggests that although the agency did not find clear evidence of increased cardiovascular risk it also did not find clear evidence of safety. Only one study examined by the FDA focused on the “subgroup of interest, i.e., diabetic patients taking high-dose olmesartan,” and it did not provide any reassurance....
This FDA communication is quite strange, in my opinion. It doesn’t sound like there’s much strong evidence either way in this case. But it seems to me that if the FDA takes four years to conduct a safety review, and if the only relevant evidence it analyzes appears to support the earlier concerns, then it shouldn’t just conclude the safety review. If anything the safety concern has increased, not decreased.
We will continue to watch for new medical journal articles concerning that study or any other research which shows an increase in cardiovascular mortality and deaths associated with Benicar.