Tuesday, June 18, 2013

FDA Investigating Deaths Following Zyprexa Injections

The Food and Drug Administration (FDA) issued an alert today stating that it is investigating two patient deaths that appear to be linked to the injectable antipsychotic medication Zyprexa Relprevv (olanzapine pamoate). The patients died three to four days after receiving intramuscular injection of the drug in appropriate doses, and the deaths occurred well after the three-hour 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, the FDA said. Under the REMS, patients must receive their Zyprexa Relprevv injection at a REMS-certified facility, be continuously monitored for at least three hours, and be accompanied home from the facility. These steps are in response to concerns about post-injection delirium sedation syndrome, a serious condition in which the drug enters the blood too fast, leading to elevated blood levels and marked sedation that can include coma, and/or to delirium.

While it investigates the two cases, the FDA is recommending that physicians follow the REMS requirements and drug-label recommendations. The alert, which was issued via the FDA's MedWatch system, also urges patients and caregivers to talk to their physician or other health professional if they have questions about the medication.

The alert can be read here.

(image: arsgera/Shutterstock.com)


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