AUDIENCE: Psychiatry, Pharmacy, Patient
ISSUE: FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. 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 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary), 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.
BACKGROUND: Treatment with Zyprexa Relprevv may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for Zyprexa Relprevv carries a boxed warning, FDA’s most serious type of warning, for post-injection delirium sedation (PDSS). This is an update to the MedWatch safety alert issued on June 18, 2013.
RECOMMENDATION: Patients should read the Medication Guide that comes with the Zyprexa Relprevv prescription each time before they get an intramuscular injection, as there may be new information. Patients receiving Zyprexa Relprevv or their caregivers should immediately report symptoms of PDSS to a health care professional.
Health care professionals should continue to follow the Zyprexa Relprevv Patient Care Program Risk Evaluation and Mitigation Strategy (REMS) requirements and current label recommendations. Notable requirements of the REMS include:
- For a patient to receive treatment, the prescriber, health care facility, patient, and pharmacy must all be enrolled in the Zyprexa Relprevv Patient Care Program.
- Zyprexa Relprevv injections must be administered at a REMS-certified health care facility with ready access to emergency response services.
- Patients must be continuously monitored at the REMS-certified health care facility for at least 3 hours following an intramuscular injection.
- Patients receiving Zyprexa Relprevv must be accompanied to their destination from the health care facility.
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
- 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
[03/23/2015 - Drug Safety Communication - FDA]
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