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News From the Food and Drug Administration
June 21, 2016

Olanzapine Linked With Potentially Fatal Skin Reaction

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Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(23):2514. doi:10.1001/jama.2016.7382

Nearly 2 dozen cases of a rare but serious skin reaction linked over the past 20 years with the antipsychotic medication olanzapine have prompted a warning from the FDA.

The agency will add information to drug labels for all olanzapine-containing products warning that they may cause drug reaction with eosinophilia and systemic symptoms (DRESS), which can start as a rash that sometimes spreads across the entire body. Fever, swollen lymph nodes, and a swollen face may accompany the rash. The condition results in a higher-than-normal number of eosinophils that can cause inflammation or swelling. In severe cases, damage to organs including the liver, kidneys, lungs, heart, or pancreas may occur.

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