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P&T Panel Changes Formulary; FDA Issues Warning About Olmesartan Medoxomil, Investigates Zyprexa Relprevv

Pharmacy Focus

June decisions by the Pharmacy and Therapeutics Committee and pertinent agenda topics are summarized in the PDF linked below. Highlights include several changes to the formulary.

P and T Committee Approvals - June 12, 2013 (PDF)

Label for Olmesartan Medoxomil to Include Sprue-Like Enteropathy

The U.S. Food and Drug Administration is warning 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. 

Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. 

Healthcare professionals should tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking a product containing olmesartan, even if it takes months to years for symptoms to develop. Patients should contact their healthcare professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away or significant weight loss.

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FDA Investigating Zyprexa Relprevv

The U.S. Food and Drug Administration is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The deaths did not occur at Cedars-Sinai.

The patients died three to four days after receiving an appropriate dose of the drug, well after the three-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death.

Under the REMS, patients are required to receive the Zyprexa Relprevv injection at a REMS-certified healthcare facility, to be continuously monitored at the facility for at least three hours after an injection, and to be accompanied home from the facility. The drug's label contains warnings about the risk of post-injection delirium sedation syndrome, a serious condition in which the drug enters the blood too quickly following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.

The FDA recommends that if therapy with Zyprexa Relprevv is started or continued, healthcare professionals should follow the REMS requirements and drug label recommendations.

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