FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv

The US Food and Drug Administration yesterday (June 18) revealed it is investigating two unexplained deaths in patients who received an intramuscular injection of US drug major Eli Lilly’s (NYSE: LLY) antipsychotic drug Zyprexa Relprevv (olanzapine pamoate), a formulation that can last two to four weeks as opposed to daily versions of Zyprexa (olanzapine), which had peak sales of round $5 billion before losing patent protection in 2011, but just $1.7 billion in 2012, compared with less than $60 million last year for the “Relprevv” version.

The patients died three-four days after receiving an appropriate dose of the drug, well after the three-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death. According to an emailed statement to Reuters and other news wires, Lilly said it was not clear whether the two deaths were related to use of the drug. "We are continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product," Lilly spokesman Morry Smulevitz said.

The FDA said it is providing this information to health care professionals while it continues its investigation. If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations. Patients and caregivers should talk to their health care professional(s) about any questions or concerns.