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FDA Drug Safety Podcast: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate)

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Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. On June 18, 2013, the FDA issued a Drug Safety Communication informing the public that the Agency is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv, active ingredient olanzapine pamoate.  The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy, also known as REMS.  Both patients were found to have very high olanzapine blood levels after death. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.

FDA 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.

Under the REMS, patients are required to receive the Zyprexa Relprevv injection at a REMS-certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility.  The Zyprexa Relprevv label contains warnings about the risk of post-injection delirium sedation syndrome, or PDSS, a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.  In the clinical trials supporting the approval of Zyprexa Relprevv, cases of PDSS were observed within 3 hours after administration of Zyprexa Relprevv, but there were no deaths due to PDSS.  These two patients died 3-4 days after receiving an appropriate dose of the drug, and it is not clear whether they died from PDSS.

At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available.

Report adverse events involving Zyprexa Relprevv to the FDA MedWatch program at www.fda.gov/medwatch.  

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 
 

 

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