Health care professionals who administer injections of the antipsychotic Zyprexa Relprevv (olanzapine pamoate) as well as patients administered the drug are being alerted by the U.S. Food and Drug Administration as the agency investigates “two unexplained deaths in patients who received an intramuscular injection” of the drug.
“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),” the FDA wrote in its June 18 statement. “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.”
The investigation ideally will determine whether the patients died from post-injection delirium sedation syndrome, or PDSS, a health risk that was observed in clinical trials, without patient death and within three hours after administration. The condition has been contained on the drug’s label.
The FDA describes PDSS as “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.”
The FDA’s announcement reminds health care professionals to follow the REMS requirements and the drug-label guidelines. It also informs Zyprexa Relprevv patients and their caregivers that they should discuss their questions or concerns with clinicians.
Zyprexa Relprevv is an Eli Lilly and Company product that the FDA approved in 2009.
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