FDA reviews 2 deaths linked to olanzapine

The FDA said it is investigating the deaths of two patients who received intramuscular injections of the antipsychotic agent olanzapine pamoate.

“At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available,” the agency said in a statement.

Both patients died 3 to 4 days after receiving “an appropriate dose” of olanzapine (Zyprexa Relprevv, Eli Lilly and Company), according to the FDA. Olanzapine is indicated for patients with schizophrenia, and its approval came with a Risk Evaluation and Mitigation Strategy (REMS) requiring that patients receive the drug at a REMS-certified facility, undergo a 3-hour post-injection monitoring period and be escorted home after treatment. Both patients had high blood levels of olanzapine. High doses of the drug can result in delirium, cardiopulmonary arrest, cardiac arrhythmias and a reduced level of consciousness.

The FDA said it will advise health care professionals as its investigation into the patients’ deaths continues.

“If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations,” the agency said. “Patients and caregivers should talk to their health care professionals about any questions or concerns.”