FDA Warns About Rare But Serious Skin Reactions With Use of Olanzapine

The US Food and Drug Administration (FDA) is warning that the antipsychotic medicine olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) can cause Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS).

The FDA is adding a new warning to the drug labels for all olanzapine-containing products that describes DRESS.

A search of the FDA Adverse Event Reporting System (FAERS) database identified 23 cases of DRESS reported with olanzapine worldwide since 1996, when the first olanzapine-containing product was approved. FAERS includes only reports submitted to FDA, so there are likely to be additional cases about which FDA is unaware.

One patient taking olanzapine experienced DRESS and died; however, this patient was taking multiple medicines that could also have contributed to death.

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. 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%.

Health care professionals should immediately stop treatment with olanzapine if DRESS is suspected.

There is currently no specific treatment for DRESS. The important ways to manage DRESS are early recognition of the syndrome, discontinuation of the offending agent as soon as possible, and supportive care. Treatment with systemic corticosteroids should be considered in cases with extensive organ involvement.

When prescribing the medicine, explain the signs and symptoms of severe skin reactions to patients and tell them when to seek immediate medical care.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online, www.fda.gov/MedWatch/report; download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.