FDA warns that olanzapine can cause severe skin reaction

The FDA recently announced that olanzapine, an antipsychotic for treatment of schizophrenia and bipolar disorder, can cause eosinophilia with systemic symptoms.

The agency is adding a warning to all products containing olanzapine regarding this condition, known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

According to the FDA Adverse Event Reporting System, 23 cases of DRESS associated with olanzapine have been reported worldwide since 1996, when olanzapine was first approved.

DRESS is a potentially fatal drug reaction with up to a 10% mortality rate.

The FDA Adverse Event Reporting System only includes submitted reports to the FDA, so there may be additional cases the agency is unaware of, according to a press release.

One individual receiving olanzapine experienced DRESS and died. However, the FDA reported that other factors may have contributed to death.

DRESS may begin as a rash that can spread to all parts of the body. Fever, swollen lymph nodes and a swollen face may occur. DRESS causes increased eosinophils that can cause inflammation or swelling. The condition can lead to injury to the liver, kidney, lungs, heart or pancreas and death.

If DRESS is suspected, the FDA recommends health care professionals immediately stop treatment with olanzapine.

Management of DRESS includes early recognition, discontinuation of the causative agent as soon as possible and supportive care.

Systemic corticosteroids should be considered for individuals with extensive organ involvement.

The FDA recommends health care professionals explain the signs and symptoms of severe skin reactions when prescribing olanzapine.