A label update is on the horizon for the prescription blood pressure medication Olmesartan medoxomil, (brand name Benicar Benicar HCT, Azor and Tribenzor by Daiichi-Sankyo, Inc.), and its generic formulations to add new safety information.
According to the FDA, the label will updated to include a warning about the risk of sprue-like enteropathy, a form of intestinal problems which include severe, chronic diarrhea which is often accompanied by extreme weight loss.
The risk was first reported in June 2012 by The Mayo Clinic. The agency has been researching the association and will continue to do so. To date it has identified twenty-three cases of serious adverse event reports linked to the drug.
Benicar was approved by the agency in 2002. In 2012, there were a total of 10.6 million prescriptions dispensed.
Patients should make an appointment to discuss the risks and benefits of this drug before making any decisions. If you are experiencing any symptoms of chronic diarrhea or weight loss while taking this drug, you should contact your doctor immediately. You can read more about the drug and safety risks on the FDA Website.