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FDA investigates deaths of Zyprexa Relprevv patients

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Health care professionals who administer injections of the antipsychotic Zyprexa Relprevv (olanzapine pamoate) as well as patients administered the drug are being alerted by the U.S. Food and Drug Administration as the agency investigates “two unexplained deaths in patients who received an intramuscular injection” of the drug.

“The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS),” the FDA wrote in its June 18 statement. “Both patients were found to have very high olanzapine blood levels after death. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.”

The investigation ideally will determine whether the patients died from post-injection delirium sedation syndrome, or PDSS, a health risk that was observed in clinical trials, without patient death and within three hours after administration. The condition has been contained on the drug’s label.

The FDA describes PDSS as “a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.”

The FDA’s announcement reminds health care professionals to follow the REMS requirements and the drug-label guidelines. It also informs Zyprexa Relprevv patients and their caregivers that they should discuss their questions or concerns with clinicians.

Zyprexa Relprevv is an Eli Lilly and Company product that the FDA approved in 2009.

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  1. up arrow

    (Zyprexa Relprevv events, dubbed post-injection delirium-sedation syndrome (PDSS), unexpectedly speedy unleash of olanzapine into circulation resulting in terribly high blood levels of the drug.)
    Thanks for posting this vital information.
    The Eli Lilly company made an astounding $70 BILLION on Zyprexa that they PUSHED on the elderly and underage children (*Viva Zyprexa* Lilly sales rep slogan) with wanton disregard for the side effects
    *FIVE at FIVE*
    The Zyprexa antipsychotic drug,whose side effects can include weight gain and diabetes, was sold to Veterans,children in foster care, elderly in nursing homes.
    *Five at Five* was the Zyprexa sales rep slogan, meaning *5mg dispensed at 5pm would keep patients quiet*.
    — Daniel Haszard Bangor Maine

  2. Betty pauley says:
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    My son is in a nursing home due to zyprexa. He went into a coma on a respirator for 3 mths 10 yrs ago because zyprexa raised his blood sugar to over 700 . He never did fully recover, he is in a wheel chair and limited rage of motion in all extremities. They have since informed the dangers of zyprexa given to persons with diabetes. Sadly it appears ovever the yrs. since this drug has been marketed that many have died in nursing homes, prisons, mental retardation facilities and other institutions where this drug has been prescribed on and off label, with increase in diabetes in people who never ha diabetes. This medication needs to be closely monitored, in both forms. Is it?