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FDA investigating Zyprexa Relprevv deaths

June 19, 2013 12:47 AM UTC

FDA issued a drug safety communication warning that two patients died 3-4 days after receiving an appropriate dose of schizophrenia drug Zyprexa Relprevv olanzapine from Eli Lilly and Co. (NYSE:LLY). The long-acting antipsychotic is approved with a REMS that requires patients be continuously monitored at a REMS-certified health care facility for at least three hours following an injection and be accompanied home from the facility. The drug's label also includes warnings about the risk of post-injection delirium sedation syndrome, a condition in which the drug enters the blood stream too fast following an intramuscular injection and causes elevated blood levels. According to the agency, the two patients had "very high olanzapine blood levels." FDA said it is providing information to health care professionals while it continues to investigate the unexplained deaths. ...