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FDA Sheds Light on Deaths Associated With Injectable Schizophrenia Drug Olanzapine

Agency sees no need to stop treatment

The FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug olanzapine pamoate (Zyprexa Relprevv, Eli Lilly) in two patients who died. The study results were inconclusive.

The FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream after intramuscular injection. The study suggested that much of the increase in drug levels 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 olanzapine pamoate.

The agency’s announcement was an update to a MedWatch safety alert issued in June 2013.

On the basis of all of the information reviewed, the FDA is not recommending any changes to the current prescribing or use of olanzapine pamoate injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals, the agency says.

Treatment with olanzapine pamoate may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for olanzapine pamoate includes a boxed warning regarding the potential for post-injection delirium sedation (PDSS).

The FDA recommends that patients read the medication guide that comes with the olanzapine pamoate prescription each time before they receive an intramuscular injection, as there may be new information. Patients receiving olanzapine pamoate or their caregivers should immediately report symptoms of PDSS to a health care professional.

Health care professionals should continue to follow the requirements of the olanzapine pamoate risk evaluation and mitigation strategy (REMS) and current label recommendations. Key requirements of the REMS include the following:

  • For a patient to receive treatment, the prescriber, health care facility, patient, and pharmacy must all be enrolled in the olanzapine pamoate patient care program.
  • Olanzapine pamoate injections must be administered at a REMS-certified health care facility with ready access to emergency response services.
  • Patients must be continuously monitored at the REMS-certified health care facility for at least 3 hours after an intramuscular injection.
  • Patients receiving olanzapine pamoate must be accompanied to their destination from the health care facility.

Health care professionals are encouraged to report adverse events or side effects related to the use of olanzapine pamoate to the FDA’s MedWatch safety information and adverse event reporting program.

Sources: FDA; March 23, 2015; and FDA; June 18, 2013.

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