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May 10, 2016: FDA Warns Of Olanzapine Serious Skin Reactions

Olanzapine Serious Skin Reactions

On May 10, 2016, the U.S. Food and Drug Administration (FDA) issued a Safety Communication regarding a dangerous side effect associated with olanzapine-containing products. The FDA will require the addition of a new warning to olanzapine labeling indicating that the medication may cause a serious skin condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).shutterstock_38537203

What is olanzapine?

Olanzapine is an antipsychotic medication used to treat mental health disorders schizophrenia and bipolar disorder. It can decrease hallucinations, in which people hear or see things that do not exist, and other psychotic symptoms such as disorganized thinking. Olanzapine is available under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and also as generics.

What is DRESS?

According to the FDA, DRESS may start as a rash that can spread to all parts of the body. It can include fever and swollen lymph nodes and a swollen face. It causes a higher-than-normal number of infection-fighting white blood cells called eosinophils that can cause inflammation, or swelling. DRESS can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. DRESS is a potentially fatal drug reaction with a mortality rate of up to 10%.
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Cases of DRESS from Olanzapine

According to the FDA Adverse Event Reporting System database, twenty-three cases, and one death, of DRESS have been reported with olanzapine use worldwide since 1996, when the first olanzapine-containing product was approved. The FDA communication notes, however, that their database only includes cases that have been reported; there are likely additional cases that have gone unreported.

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