Zyprexa Relprevv Patient Deaths Prompt FDA Investigation

Washington, DCThe Food and Drug Administration (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.

Zyprexa Relprevv is the long-acting version of the oral version of Zyprexa, which is taken daily. Zyprexa Relprevv is injected every two to four weeks. 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.

Zyprexa (olanzapine), prescribed for the treatment of schizophrenia and bipolar mania, has been linked to serious side effects. These Zyprexa side effects reportedly include diabetes mellitus, hyperglycemia, pancreatitis and increased risk of suicide. According to some lawsuits, Eli Lilly, maker of Zyprexa, allegedly knew about the link between Zyprexa and diabetes but failed to adequately warn the public about that risk.