FDA: Agency Review of Heart Risks for Diabetics Taking Olmesartan Not Conclusive; Label Updates Needed

FDA-Agency-Review-of-Heart-Risks-for-Diabetics-Taking-OlmesartanThe U.S. Food and Drug Administration (FDA) just issued a Drug Safety Communication indicating that the agency’s review of cardiovascular risks for people diagnosed with diabetes who are taking the hypertension drug, olmesartan, are not conclusive. The agency also found that label updates are required on these drugs.

Olmesartan is sold under the brand names Benicar, Benicar HCT, Azor, and Tribenzor, and is also sold in generic forms.

The FDA indicated that, at the conclusion of its safety review of olmesartan, no clear evidence of increased heart risks were tied to use of this blood pressure drug in patients diagnosed with diabetes. Although the FDA indicated that its recommendations for the use of the drug, and its generic versions, will remain unchanged, the agency indicated that it will require information about some of the studies to be included in the drugs labels.

The FDA’s safety review was prompted by the results of the ROADMAP—Randomized Olmesartan and Diabetes Microalbuminuria Prevention—clinical trial that reviewed the effects of olmesartan in patients with type 2 diabetes to determine if olmesartan could delay kidney damage. The research revealed an unexpected finding of increased risk of cardiovascular death in the olmesartan group when compared to the group who were taking a placebo, according to the FDA. The risk of non-fatal heart attack was lower in the group taking olmesartan.

The agency indicated that, to evaluate the findings, it reviewed additional studies, including one large study conducted in Medicare patients. The FDA indicated that, overall, it determined that the studies did not clearly indicate an increased cardiovascular risk. Because of this, wrote the FDA, the collective evidence currently available does not support changing the agency’s recommendations for olmesartan use and does not support recommending that its use be avoided in patients who are diagnosed with diabetes.

Olmesartan is blood pressure medicine in the class of drugs known as angiotensin receptor blockers, or ARBs. Some 1.8 million people received a dispensed prescription for drugs containing olmesartan in 2013 from United States outpatient retail pharmacies.

The FDA posted two prior Drug Safety Communications concerning olmesartan. The first was issued in June 2010 and discussed the ongoing review of olmesartan and cardiovascular events. The second Drug Safety Communication was issued in April 2011.

The FDA notes that it is important that patients continue to take their prescribed olmesartan and other blood pressure medicines as uncontrolled high blood pressure increases cardiovascular risks, including heart disease and stroke. Uncontrolled high blood pressure also increases risks for kidney failure and other health problems. No blood pressure medication, including olmesartan, should be stopped without physician oversight.

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