FDA Warning on BP Med

Clinical trials are to undergo improvements, after the FDA issued draft guidance today to help researchers and manufacturers design better quality trials.

Food and Drug Administration regulators have issued a warning on the blood pressure drug known generically as olmesartan medoxomil, sold a Benicar. The drug can cause intestinal problems known as spruelike enteropathy, which has side effects including severe, chronic diarrhea and substantial weight loss, sometimes requiring hospitalization. The warning is the result of research done at the Mayo clinic in Rochester Minnesota. The FDA reported that the intestinal problems can develop months to years after a patient starts taking the drug.

The drug is in a class known as angiotensin II receptor blockers, or ARBs.

A release from the Mayo Clinic quotes Joseph Murray, M.D. as saying, "We are still seeing new cases where the doctor was not aware of the problem. The FDA has done the right thing, and their warning will bring this to the notice of doctors."

Dr. Murray has the following advice for patients and physicians.

For patients on olmesartan:

*If you feel well and have no unexplained weight loss, diarrhea or signs of malabsorption, then olmesartan is a good drug for blood pressure. These side effects are quite rare. However, if you get these symptoms, even if you have been on the drug for years, then talk with your doctor about alternatives.

*If you have been diagnosed with celiac disease while on olmesartan, you need to be re- evaluated to check the diagnosis.

For doctors:

*As advised for patients, physicians need to be aware of this problem. The side effects can happen even years after the drug is started and seem to be tolerated quite well.

*Consider avoiding the use of olmesartan in patients with a history of chronic diarrhea illness or celiac disease.


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