Zyprexa Relprevv olanzapine long-acting injection regulatory update

FDA issued a drug safety communication warning that 2 patients died 3-4 days after receiving an appropriate dose of schizophrenia drug Zyprexa Relprevv olanzapine from Eli Lilly. The long-acting antipsychotic is approved with a REMS that requires patients be continuously monitored at a REMS-certified health care facility for >=3 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 2 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. ...