FDA Warns About Rare Skin Reaction from Zyprexa

zyprexaMay 10, 2016 — The FDA has issued a Safety Communication to warn about rare but serious skin reactions from anti-psychotic medications like Zyprexa.

The FDA has received reports of patients on olanzapine who developed a severe skin condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

DRESS causes a higher-than-normal number of infection-fighting white blood cells called eosinophils that can cause inflammation, or swelling.

Patients should seek emergency medical attention if they develop fever, rash, swollen lymph glands, or swelling in the face.

The FDA does not recommend stopping the medication without first talking to a doctor. However, the agency warns:

“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.”

The agency has received 23 reports of DRESS in patients treated with olanzapine worldwide since 1996. To put this risk in perspective, about 850,000 patients in the United States received a prescription for olanzapine last year alone.

Most of the cases occurred within two months of starting olanzapine. One patient died from cardiac arrest, but other medications may have contributed to the death.

DRESS is a potentially deadly drug-reaction with up to a 10% mortality rate. Experts do not fully understand what causes the reaction, but it is believed to involve an immune response to toxic metabolites of the drug. There is currently no specific treatment for DRESS, but corticosteroids can reduce inflammation.

Olanzapine is an active ingredient in the following medications:

  • Zyprexa
  • Zyprexa Zydis
  • Zyprexa Relprevv
  • Symbyax

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