FDA: No Changes to Injectable Zyprexa Prescribing After Deaths

The FDA is not recommending any changes to the prescribing or use of Eli Lilly’s injectable antipsychotic Zyprexa Relprevv (olanzapine pamoate) after an agency review could not conclusively say that the drug led to the deaths of two people who received injections.

The FDA said that it is still possible “that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.” However, the agency’s analysis found that the high level of olanzapine pamoate found in the bloodstreams of the two deceased people could have happened after the death.

In 2013, the patients died and were found to have very high levels of olanzapine pamoate, which is approved for treatment of schizophrenia, in their bloodsteam, three to four days post-injection, prompting the FDA to issue a MedWatch safety alert in June of that year.

Zyprexa Relprevv requires three hours of monitoring post-injection, based on the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Patients receiving the drug must receive the injection at a REMS-certified facility and be accompanied home after the injection.

Labeling for Zyprexa Relprev carries a boxed warning for post-injection delirium sedation (PDSS). The FDA is recommending that health care practitioners continue to follow the REMS requirements and label recommendations.

Reference

FDA Drug Safety Communication. FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate). March 23, 2015.