FDA Alerts
FDA Approves Label Changes to Blood Pressure Medicine Olmesartan Medoxomil
The US Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.
FDA Drug Safety Communication: Benicar
After reviewing the results of the ROADMAP and ORIENT trials, the 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 ...