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FDA Warns Antipsychotic Medicine Olanzapine may cause Serious Skin Condition

May 13, 2016

The U.S. Food and Drug Administration (FDA) has issued a warning regarding the antipsychotic medicine olanzapine stating it can cause a "rare but serious" condition. Olanzapine is available under the Eli Lilly & Co. brand names of Zyprexa, Zyprexa Zydis, Zyprexa Relprevv and Symbyax, as well as generics, and is used in the treatment of schizophrenia and bipolar disorder, Law360 reports.

Olanzapine can cause a potentially fatal skin reaction that can progress to affect other parts of the body. The FDA announced it is adding a new warning to the drug labels for all olanzapine-containing products telling consumers it can start as a rash and result in organ injury.

FDA's database identified 23 cases of the skin reaction reported with olanzapine worldwide since 1996, when the first olanzapine-containing product was approved. The database includes only reports submitted to the FDA so there may be additional cases about which the agency is unaware, according to the FDA's notice.

One patient taking olanzapine suffered the serious reaction and died. However, the FDA remarked that this patient had been taking multiple medicines that could have contributed to the death. The FDA said such a reaction may start as a rash that can spread all over the body. It can include fever, a swollen face, and lymph nodes. Also, a higher-than-normal number of infection-fighting white blood cells, called eosinophils, can cause inflammation or swelling, according to the FDA.

The drug reaction with eosinophilia and systemic symptoms can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and may lead to death. The reaction is potentially fatal with a mortality rate of up to 10 percent, says the FDA.

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