Product News and Recalls

FDA Requires Benicar To Carry Enteropathy Warning

Benicar shown to cause diarrhea and weight lossThe U.S. Food and Drug Administration is investigating whether olmesartan-based blood pressure drugs Benicar, Azor, and Tribenzor increase the risk of enteropathy.

Benicar, known as olmesartan, an angiotensin II receptor blocker, was approved by the FDA on April 25, 2002, to treat high blood pressure. It is manufactured under the brand names Benicar, Benicar HCT, Azor, and Tribenzor.

Recently, the FDA issued a safety warning that Benicar, Azor, and Tribenzor can cause intestinal problems known as sprue-like enteropathy. Symptoms of this disorder include severe, chronic diarrhea with substantial weight loss. In deciding to require new warnings, the FDA has evaluated numerous adverse event reports and found a direct link between Benicar, other olmesartan drugs like Azor and Tribenzor, and sprue-like enteropathy. Twenty three serious cases were identified in these reports “as late-onset diarrhea with significant weight loss and, in some cases, with intestinal villous atrophy on biopsy. All patients improved clinically after discontinuing the drug, and a positive rechallenge was seen in ten of the cases.”

Benicar required to carry additional warnings for diarrhea and enteropathyThe fact that all patients improved after stopping Benicar and 10 had symptoms worsen again after restarting treatment (known as a “positive rechallenge”) is powerful evidence that olmesartan drugs like Benicar, Azor, and Tribenzor are linked to the enteropathy side-effect. Because of this, the FDA is requiring additional warnings. This evidence will also likely be helpful in ongoing Benicar lawsuits.

The Mayo Clinic conducted a case series in June of 2012 that yielded similar results, and drug discontinuation resulted in clinical improvement. In the series, eighteen patients showed recovery or improvement after discontinuing Benicar.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Benicar lawyer if you have any of the injuries described above while taking Benicar or another olmesartan like Azor or Tribenzor.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, here.