Zyprexa Relprevv is an antipsychotic that helps correct chemical imbalances in the brain and is used to treat symptoms of schizophrenia, a mental illness with disturbances in thinking, feelings, and behavior. This antipsychotic drug is given as an injection into a large muscle in the buttock where it is slowly released over the next two to four weeks.
The Food and Drug Administration (FDA) announced it is investigating two unexplained deaths in patients who received an injection of Zyprexa Relprevv. The two patients died three to four days after receiving an appropriate dose of the antipsychotic drug, which is well past the three hour post injection monitoring period that is required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).
According to the press release, both patients who died from the injection, were found to have very high oanzapine blood levels, which can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced levels of consciousness ranging from sedation to coma.
REMS requires patients to receive injections of Zyprexa at a REMS-certified facility, to be continually monitored for three hours at the facility after injection of the drug, and to be accompanied home from the facility, as well.
A patient can suffer post-injection delirium sedation syndrome (PDSS) should the drug enter his blood too fast after an intramuscular injection, thus the three hour observation requirement after an injection. In clinical trials, PDSS was observed within three hours of injection, but no deaths occurred because of the syndrome.
The FDA is continuing its investigation into the deaths and cautions health care providers to follow the REMS requirements and drug label recommendations, as well.