Prescription drug Olmesartan medoxomil (marketed as Benicar), used to treat blood pressure, will be getting a label update, according to the U.S. Food and Drug Administration (FDA).
The label will be updated to include a warning about the risk of sprue-like enteropathy, a form of intestinal problems that includes symptoms of severe, chronic diarrhea accompanied by excessive weight loss.
The associated between the drug and safety risk was first reported by The Mayo Clinic in June 2012. According to researchers, 22 patients had been diagnosed with symptoms of celiac disease, but blood tests did not confirm the diagnosis. In late 2012, researchers at American College of Gastroenterology noted that olmesartan had been linked to another 40 such cases of sprue-like enteropathy.
The agency has found supportive evidence that the link between olmesartan and sprue-like enteropathy and will continue to research. It has identified 23 cases of serious Adverse Event Reports that presented late-onset diarrhea with excessive weight loss and other symptoms. All patients improved after discontinuing the drug.
The dug was initially approved in 2002. An estimated total of 10.6 million prescriptions were dispensed in 2012.
If you take Benicar and have been experiencing severe diarrhea and/or weight loss, please contact your doctor immediately. It is best to keep taking the drug as prescribed until you can see your doctor to review your risks and options.