FDA safety review of Zyprexa Relprevv calls for no changes to current prescribing

The US Food and Drug Administration has concluded a review of a study undertaken to determine the cause of elevated levels of US pharma major Eli Lilly’s (NYSE: LLY) injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died.

The agency said that the study results were inconclusive. The FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died three to four days after receiving injections of appropriate doses of Zyprexa Relprevv.

On the basis of all of the information reviewed, the FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.