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Results of FDA review of injectable Zyprexa, two deaths inconclusive
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The FDA has determined that the review of a study to examine the cause of elevated levels of injectable Zyprexa Relprevv in two patients who died to be inconclusive, according to an FDA MedWatch safety announcement.
Zyprexa Relprevv (olanzapine pamoate, Eli Lilly) is indicated for patients with symptoms of schizophrenia, including hearing or seeing things that are not there, being suspicious or withdrawn.
An initial MedWatch safety alert was issued on June 18, 2013, following the deaths of two patients.
“The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection,” the announcement states. “The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv.”
At this time, FDA has not made any recommendations for changes to the current prescribing practices for this treatment, according to the announcement.
Health care professionals are urged to continue to follow the Zyprexa Relprevv Patient Care Program Risk Evaluation and Mitigation Strategy requirements and label recommendations, and report any adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Reference:
Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug. Accessed March 23, 2015.