[UPDATED 03/23/2015] New information is now available.
AUDIENCE: Health Professional, Pharmacy, Patient
ISSUE: FDA is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (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 (REMS). Both patients were found to have very high olanzapine blood levels after death.
BACKGROUND: 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 (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
RECOMMENDATION: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/18/2013 - Safety Communication - FDA]