Label Changes for:

Benicar HCT (olmesartan medoxomil/ hydrochlorothiazide) Tablets

July 2013

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

July 2013

WARNINGS AND PRECAUTIONS

Sprue-like Enteropathy
  • Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified

ADVERSE REACTIONS

Post marketing Experience
  • sprue-like enteropathy

 

December 2012

 

PRECAUTIONS

Drug Interactions
  • Colesevalam Hydrochloride: Concurrent administration of bile acid sequestering agent Colesevelam Hydrochloride reduces the systemic exposure and peak plasma concentration of Olmesartan…

 

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