June 25, 2014 — 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. This includes Benicar, Benicar HCT, Azor, Tribenzor and generics.
FDA said that it believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.
FDA safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients.
Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional. Recommendations for use of olmesartan remain the same, but FDA will require information about some of the studies to be included in the drug labels.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
- Complete and submit the report online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Read the MedWatch safety alert, including a link to the Drug Safety Communication
For more information: www.fda.gov/MedWatch/report.htm, www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402616.htm
February 16, 2024 
