Medication Monitor

Generic Name (Trade Name—Company)
June 18, 2013

Olanzapine pamoate

(Zyprexa Relprevv —Eli Lilly)
Two deaths reported in patients who were treated with antipsychotic

FDA is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug olanzapine pamoate. The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the olanzapine pamoate Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death.

Under REMS, patients are required to receive the olanzapine pamoate injection at a REMS-certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility. The olanzapine pamoate label contains warnings about the risk of post-injection delirium sedation syndrome, a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.

FDA is continuing its investigation. If therapy with olanzapine pamoate is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations. Patients and caregivers should talk to their health care professional(s) about any questions or concerns.