Zyprexa, Olanzapine Labels To Warn Of Rare, Potentially Fatal Skin Reaction

(May 10, 2016, 1:43 PM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on May 10 said it is adding a warning to the labels of Zyprexa and generic equivalent olanzapine for Drug Reaction with Eosinophilia and System Symptoms (DRESS), a rare but potentially fatal skin reaction to the antidepressants.

The FDA said its Adverse Event Reporting System database identified 23 DRESS reports worldwide since 1996, when Zyprexa was first approved. The agency says there are likely to be additional unreported cases.

One person in the database died, but he...
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