FDA Finishes Review of Patient Deaths Post-Zyprexa Relprevv Injection
The Food and Drug Administration (FDA) stated that study results were inconclusive regarding the investigation of two deaths following the injection of Zyprexa Relprevv (olanzapine pamoate extended-release injectable suspension; Eli Lilly) from June 2013. Zyprexa Relprevv is a long-acting antipsychotic agent indicated for the treatment of schizophrenia.
After the patients' deaths, the FDA requested the manufacturer conduct an animal study to see whether movement of olanzapine into the blood after death could lead to levels higher than anticipated. Some animals showed increased drug levels after death, which could explain the high levels found in the two patients who died.
Overall, the FDA was unable to rule out the possibility that the patients' deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular (IM) injection. The increase in drug level may have occurred after death, as the two patients died 3–4 days after receiving appropriate doses of Zyprexa Relprevv.
At this time, the FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection. Healthcare professionals are to continue following the Zyprexa Relprevv Patient Care Program REMS requirements and current label recommendations.For more information visit FDA.gov.