FDA Finishes Review of Zyprexa Relprevv Patient Deaths
About Zyprexa Relprevv
Zyprexa Relprevv is a long acting, intramuscular injection formulation of the pill form of the Zyprexa antipsychotic, which is used to treat schizophrenia, according to drugs.com.
Eli Lilly makes Zyprexa Relprevv, chemical name olanzapine pamoate, and received FDA approval for the drug in 2009. Family Practice News reports that Zyprexa Relprevv requires a Risk Evaluation and Mitigation Strategy, REMS, and that its use is tightly controlled and limited to REMS certified health care facilities.
FDA Safety Review of Zyprexa Relprevv is Inconclusive
Reuters reports that the investigation into Zyprexa Relprevv was started after two people died three to four days after being given the drug and they were found to have very high levels of Zyprexa in their systems.
The FDA announced the investigation in mid-2013 and said that the patients been given the appropriate dose of Zyprexa Relprevv.
Monthly Prescribing Reference reports that Eli Lilly conducted animal studies to investigate why the drug levels were so high, but the inconclusive results mean the FDA cannot exclude the possibility of a delayed rapid release of the drug into the bloodstream as the cause of the deaths. PharmacyTimes reports that due to the inconclusive nature of the investigation the FDA will not recommend any label or prescribing changes to Zyprexa Relprevv.
High Levels of Zyprexa Relprevv Can Have Serious, Potentially Deadly, Effects
The FDA has placed a boxed warning, the most serious warning the agency issues, on Zyprexa Relprevv to warn of post-injection delirium sedation syndrome, PDSS, which can occur after injection and is caused by high levels of the drug in the person’s system.
PsychCentral reports that PDSS was reported during clinical trials but occurred within three hours of injection and did not lead to any deaths. The label for Zyprexa Relprevv requires that a person being given the drug be monitored, in a certified facility, for three hours after the injection and to be accompanied home.
Bloomberg reports that high levels of Zyprexa Relprevv can cause the following symptoms and complications:
- Cardiac arrest
- Heart arrhythmias
- Loss of consciousness