FDA Warning: Olanzapine Can Cause Serious Skin Reactions

The US Food and Drug Administration (FDA) has issued a warning that the antipsychotic medicine olanzapine can cause a condition known as drug reaction with eosinophilia and systemic symptoms (DRESS), a rare but serious skin reaction that starts as a rash and can spread to all parts of the body.  

Used to treat the mental health disorders schizophrenia and bipolar disorder, olanzapine is known to decrease hallucinations and other psychotic symptoms such as disorganized thinking, the FDA notes in its recent statement warning health care professionals about the use of the drug.
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DRESS can include fever, swollen lymph nodes, and a swollen face, and can also cause a higher than normal number of infection-fighting white blood cells called eosinophils, which can lead to inflammation or swelling. DRESS may result in injury to organs including the liver, kidneys, lung, heart, or pancreas, and is a potentially fatal drug reaction with a mortality rate of up to 10%.

According to the FDA, a search of its Adverse Event Reporting System (FAERS) database revealed 23 cases of DRESS reported with the use of olanzapine worldwide since 1996, when the first olanzapine-containing product was approved. FAERS, however, only includes reports submitted to the FDA. As such, the organization says “there are likely to be additional cases about which the FDA is unaware,” noting that 1 patient taking olanzapine experienced DRESS and died, although the FDA points out that this patient was taking multiple medicines at the time, which could have contributed to death.

The organization recommends that patients taking products containing olanzapine should seek immediate medical care if they develop a fever with a rash and swollen lymph glands, or swelling in the face.

The FDA also suggests that “healthcare professionals should immediately stop treatment with olanzapine if DRESS is suspected,” said FDA spokesperson Kristofer Baumgartner, noting that there is “currently no specific treatment for DRESS.”

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

—Mark McGraw

Reference:

FDA. Olanzapine: drug safety communication - FDA warns about rare but serious skin reactions. May 10, 2016. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500123.htm.