FDA Investigating Two Deaths Following Use of Antipsychotic Zyprexa Relprevv

The United States Food and Drug Administration is currently investigating the death of two individuals who died a few days following the injection of the intramuscular antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).

The FDA reports that the individuals died three to four days after receiving “an appropriate dose of the drug.” The individuals died “well after the 3-hour post-injection monitoring period,” which “is required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).” The REMS requires the injection to occur at a certified healthcare facility with continuous monitoring for at least three hours following the injection. It also requires the patient to be accompanied home from the facility.

Both individuals allegedly had very high olanzapine blood levels after their deaths. Elevated levels of olanzapine can lead to a condition defined and included on the Zyprexa label as post-injection delirium sedation syndrome (PDSS). PDSS is “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.”

According to MedScape, the Zyprexa Relprevv label also contains black box warnings stating it is not approved for dementia-related psychosis. The label further states that short-term clinical trials show that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. The deaths occurring during the short-term trials appeared to be related to either cardiovascular problems or infections. It is unclear if the recent deaths happened because of these black box warnings.

Zyprexa is typically used for treating aggression, depression, manic episodes, schizophrenia and bipolar disorders, according to Bloomberg. Zyprexa’s sales peaked at $5.03 billion in 2010. The intramuscular form of Zyprexa Relprevv is meant to offer schizophrenia patients, who often fail to regularly take medication, weeks of symptom control.

A spokesperson for Eli Lilly & Co., the manufacturer of Zyprexa Relprevv, told Reuters that while there have been 82 previous deaths of patients who took the drug since it first hit the market, the company couldn’t determine a pattern or trend between the deaths of the patients and the use of the drug.

The FDA is still conducting its investigation into the deaths of the two individuals.