FDA: Statement on Olmesartan Use in Diabetic Patients
The FDA has announced that it has completed its safety review of olmesartan medoxomil and has found no clear evidence of increased cardiovascular risks associated with the use of the drug in patients with diabetes. Olmesartan medoxomil, an angiotensin II receptor blocker, is indicated for the treatment of hypertension and is found in the following brand products: Benicar, Benicar HCT, Azor, and Tribenzor.
The safety review was prompted by the results of the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) clinical trial, which evaluated the effects of olmesartan medoxomil in delaying kidney damage for patients with type 2 diabetes. An increased risk of cardiovascular mortality was found in the olmesartan group compared to placebo but the risk of non-fatal heart attack was lower in patients treated with olmesartan medoxomil compared to placebo. After reviewing additional studies that included a large study of Medicare patients, the FDA was unable to find clear evidence of increased cardiovascular risk in diabetic patients taking olmesartan medoxomil.
While recommendations for olmesartan medoxomil use in patients with diabetes will remain the same for now, the 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.
For more information visit FDA.gov