FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events
[4/14/2011] After reviewing the results of the ROADMAP and ORIENT trials,1-2 FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Benicar is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients.
Patients should consult their healthcare professional if they have any questions or concerns about taking Benicar.
Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings. FDA will update the public when new information is available.
- 1. Haller H, Ito S, Izzo JL, et al. Olmesartan for the delay or prevention of microalbuminuria in Type 2 Diabetes. N Engl J Med 2011;364:907-17.
- National Institutes of Health. Clinicaltrials.gov trial webpage for ORIENT trial. Available at http://www.clinicaltrials.gov/ct2/show/NCT00141453?term=ORIENT+olmesartan&rank=1 . Accessed March 22, 2011.
- FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required
- FDA Drug Safety Communication: Ongoing safety review of Benicar(olmesartan) and cardiovascular events
- ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
- Olmesartan (marketed as Benicar) Information