FDA Investigating 2 Deaths After Zyprexa Injections for Schizophrenia
Long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate) is under scrutiny after the U.S. Food and Drug Administration’s (FDA) turned up two deaths following the injection of the drug.
The two patients received the appropriate dose of Zyprexa Relprevv, then died 3-4 days later.
Zyprexa Relprevv (olanzapine pamoate) is manufactured by Eli Lilly and first approved for use in the United States in 1996. It is an extended release injectable suspension, meaning it is injected only once every 2 or 4 weeks in most patients.
After injection, patients are typically monitored for a 3-hour post-injection period — required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (also known as REMS). According to the FDA, “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.”
It’s not clear that the REMS protocol was followed in both patents who died.
According to the FDA, “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 FDA suggests doctors and patients don’t discontinue use of Zyprexa Relprevv at this time: “If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations.”
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. This can cause greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.
In the clinical trials supporting the approval of Zyprexa Relprevv, cases of PDSS were observed within 3 hours after administration of Zyprexa Relprevv. But there were no deaths due to PDSS found in those initial clinical trials, according to the FDA report.
Schizophrenia is a mental disorder that affects around one in 100 people worldwide. Its most common symptoms are delusions and hallucinations, most often the hearing of voices or people talking when nobody is there.
One of the biggest challenges for individuals suffering from schizophrenia is taking medication as it is prescribed. Injectibles such as Zyprexa Relprevv are meant to help alleviate this problem.
Source: U.S. Food and Drug Administration
Grohol, J. (2013). FDA Investigating 2 Deaths After Zyprexa Injections for Schizophrenia. Psych Central. Retrieved on November 27, 2015, from http://psychcentral.com/news/2013/06/18/fda-investigating-2-deaths-after-zyprexa-injections-for-schizophrenia/56226.html