Olmesartan induced enteropathy

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FDA warns that Olmesartan may induce Sprue-like enteropathy, and approves the label changes on 3rd July 2013.

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Olmesartan induced enteropathy

  1. 1. Olmesartan induced Enteropathy P.Naina Mohamed Pharmacologist
  2. 2. Olmesartan  Olmesartan is one of several angiotensin II receptor blocking (ARB) agents.  Olmesartan has been shown to have a longer half-life and a greater effect on systolic blood pressure than other ARB agents, making it widely prescribed for the management of hypertension. Olmesartan medoxomil (Inactive ester prodrug) Hydrolysis (GIT) Olmesartan (Active form) Blockade of AT1 receptor Reduction of Blood Pressure
  3. 3. FDA Warning  FDA is warning on 3rd July 2013, that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.  Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.  FDA has approved changes to the labels of these drugs to include this concern.  Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan.  FDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available.  Health care professionals should tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop.  Patients should contact their health care professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away, or significant weight loss.
  4. 4. Possible Mechanism of development of Enteropathy Olmesartan medoxomil (Inactive ester prodrug) Hydrolysis (GIT) Olmesartan (Active form) Cell-mediated immune response Damage to the small intestinal brush border Spruelike enteropathy Severe, chronic diarrhea with substantial weight loss
  5. 5. References  http://www.fda.gov/Safety/MedWatch/SafetyInformat ion/SafetyAlertsforHumanMedicalProducts/ucm3595 28.htm?source=govdelivery  Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor  Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e Laurence L. Brunton, Bruce A. Chabner, Björn C. Knollmann
  6. 6. References  http://www.ncbi.nlm.nih.gov/pubmed/22728033  http://www.mayoclinicproceedings.org/article/S0025- 6196(12)00558-7/fulltext  http://www.hindawi.com/crim/gm/2013/618071/  http://www.iscpcardio.org/expert-opinion/iscp- features/severe-spruelike-enteropathy-associated- with-olmesartan/  http://www.theheart.org/article/1419079.do

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