FDA Investigation into Schizophrenia Drug Deemed Inconclusive

The FDA’s review of 2 patient deaths associated with Lilly’s injectable schizophrenia drug, olanzapine pamoate (Zyprexa Relprevv), produced inconclusive results, leaving the drug’s label and recommended use unchanged.

However, the FDA could not exclude the possibility that the deaths were caused by the drug’s rapid yet delayed entry into the bloodstream. The data indicated that the elevated drug levels could have occurred after death, as both patients died 3 to 4 days after receiving the appropriately dosed injections.

Based on these data, the FDA has not altered Zyprexa Relprevv’s label and is not recommending any changes to the prescribing or use of the drug.

The FDA advised health care professionals to continue to follow the Zyprexa Relprevv Patient Care Program Risk Evaluation and Mitigation Strategy requirements and current label recommendations. The agency also noted that patients should not stop receiving treatment without consulting their health care professional first.

Zyprexa Relprevv currently carries a boxed warning for post-injection delirium sedation (PDSS), and the FDA said those receiving the drug should immediately report PDSS symptoms to a health care professional.