June 18, 2013 — The FDA has issued a Drug Safety Communication to announce they are investigating two deaths in patients who received intramuscular injections of Zyprexa (olanzapine).
Hospitals are required to continually monitor patients for 3-4 hours after an injection of the anti-psychotic medication. However, both patients died 3-4 days after their injection and had “very high” levels of Zyprexa in their bloodstream.
Zyprexa already carries a “Black Box” warning about the risk of post-injection delirium sedation syndrome (PDSS). This condition occurs when the drug enters the bloodstream too quickly after an injection. Patients with elevated levels of the drug in their blood are at risk of delirium, cardiopulmonary arrest, cardiac arrhythmias, extreme sedation, coma, and death.
During clinical trials of Zyprexa, researchers identified cases of PDSS in the first 3 hours after an injection of the drug. However, the trials did not identify any deaths. It is still unclear whether the patients’ injections of Zyprexa caused their death.
The FDA concluded: “At this time, the FDA is continuing to evaluate these deaths and will provide an update when more information is available.”
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