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FDA Investigates Two Deaths Linked to Zyprexa

June 18, 2013 — In a Drug Safety Communication, the U.S. Food and Drug Administration (FDA) announced that they will investigate two unusual deaths associated with the anti-psychotic medication Zyprexa Relprevv.

The FDA currently recommends that hospitals monitor patients for 3-4 hours after they receive an injection of Zyprexa. The two patients died 3-4 days after receiving an injection. Blood tests showed “very high” levels of Zyprexa.

The FDA has already placed a “Black Box” warning on the label for Zyprexa for post-injection delirium sedation syndrome (PDSS). The life-threatening condition occurs when levels of the drug increase rapidly in a patient’s bloodstream. Complications can include delirium, irregular heart rhythm, cardiopulmonary arrest, sedation, coma, and death.

Researchers identified cases of PDSS in patients who were given Zyprexa, but only during the first 3 hours. They did not identify any deaths during clinical trials. The FDA still does not know whether Zyprexa contributed to the deaths of the two patients, and 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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