Schizophrenia Daily News Blog

Long-Acting Zyprexa Works, But Has Sedation Risks

The Food and Drug Administration (FDA) announced today that a long-acting, injectable form of Eli Lilly & Co.'s medication called Zyprexa was effective at treating schizophrenia but caused "profound sedation" in about 1% of patients. This new version of Zyprexa (Olanzapine) is a Long Acting Injection, a depot formulation of olanzapine intended for administration every 2-4 weeks.

A memo from the FDA's psychiatry products division and and available on the agency's Web site today said clinical studies of the drug showed 24 out of 1,915 patients exposed to the long-acting form of Zyprexa experienced "profound sedation" after receiving the injection. The FDA suggested that the sedation commonly lasted one to three hours.

Its been reported by the Wall Street Journal that Lilly has stated that the extreme sedation that has been seen with the long-acting, injectable form of Zyprexa can be safely managed and said patients and health-care providers can be adequately warned of the risk. The FDA has stated that the sedation that has been experienced on occasion with the long-acting form of Zyprexa seems to be only experienced with the injectable version of the medication and appears to result from the rapid release of the drug into a patient's body after being injected.

This new version of Zyprexa faces a review by an FDA panel of outside medical experts this Wednesday. The FDA will ask the panel if this new form of Zyprexa has been shown to be "acceptably safe" and effective for the treatment of schizophrenia. The Wall Street Journal reported that this panel's report will "amount to a recommendation about whether the FDA should approve the product."

More Detailed information:

FDA memo with full information on Zyprexa Long Acting Injectable medication (PDF)

Additional FDA Information on this new medication (List of PDFs)