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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients. As a result, our recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but we will require information about some of the studies to be included in the drug labels. Patients should discuss any questions they have with their health care professionals.
It is important to take olmesartan and other blood pressure medicines because uncontrolled high blood pressure increases the risks of cardiovascular problems such as heart disease and stroke, as well as kidney failure and other health problems. Do not stop taking olmesartan or any blood pressure medication without first discussing it with your health care professional.
For more information, please visit: olmesartan.
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