FDA Finds No New Problems With Zyprexa Relprevv After Safety Review

Federal drug regulators have given the green light to Zyprexa Relprevv, after a safety review launched following the deaths of two patients found no new problems associated with the long-acting injections. 

The FDA issued a drug safety communication on March 23, indicating that it has concluded a review into two patient deaths linked to Zyprexa Relprevv, determining that no new label warnings are recommended for the drug.

The safety review into the Zyprexa Relprevv deaths was launched in June 2013, and appears to have turned up few answers.

The two patients died three to four days after receiving injections of long-acting Zyprexa Relprevv. The doses were appropriate in size, however high levels of the drug were found in their bodies after their deaths.

“The study results were inconclusive,” the FDA review determined. “We are unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.”

FDA investigators said that the drug level increases could have occurred after the patients died. Animal tests by Eli Lilly at the FDA’s request appear to have confirmed that those increases can happen after death.

Zyprexa Relprevv (olanzapine pamoate) is a long-acting injectable version of the atypical antipsychotic Zyprexa. The Eli Lilly drug is approved for the treatment of schizophrenia, but the FDA was so concerned about the safety of the drug when it was approved in 2009, that it is only available through a Risk Evaluation and Mitigation Strategy (REMS) that requires three hours of post-injection monitoring.

High levels of Zyprexa in the blood can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and a can reduce consciousness; causing anything from sedation to coma. The drug carries a black box warning alerting doctors and patients to the condition, known as post-injection delirium sedation (PDSS).

The REMS program for Zyprexa Relprevv requires that the injections be given at a REMS-certified health care facility, three hours of monitoring after the injection, and that the patient be accompanied home from the facility where they were injected. However, the monitoring ends after the three-hour period, after which it is generally assumed that the patient is safe from the risk of high levels of Zyprexa in the blood.