The FDA is investigating the death of two patients who received an intramuscular (IM) injection of Zyprexa Relprevv (olanzapine pamoate extended-release injectable suspension; Lilly). Zyprexa Relprevv is a long-acting antipsychotic that was approved in 2009 for the treatment of adults with schizophrenia.

The patients were found to have very high blood levels of olanzapine 3–4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). The Zyprexa Relprevv REMS program also requires patients to receive the injection at a REMS-certified health care facility and to be accompanied home from the facility.

The labeling for Zyprexa Relprevv contains a warning about the risk of post-injection delirium sedation syndrome (PDSS) in which the drug enters the blood too fast following an IM injection. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma. These two patients died 3-4 days after receiving an appropriate dose of the drug, and it is not clear whether they died from PDSS.

The FDA recommends that if Zyprexa Relprevv is started or continued in patients, healthcare professionals should follow the REMS requirements and drug label recommendations. The FDA will provide more updates when more information is available.

For more information call (800) 332-1088 or visit the FDA website