Understanding the FDA Warning on Cetirizine/Levocetirizine

Welcome to a special episode of AllergyTalk, a roundup of the latest in the field of Allergy and Immunology by the American College of Allergy, Asthma & Immunology!

On May 16, 2025, the FDA issued an alert regarding a rare but serious side effect of severe pruritus after discontinuing long-term use of cetirizine and levocetirizine. In this episode, we’ll discuss the background of this important announcement and what it means for our patients!

We are joined by Michael S. Blaiss, MD, clinical professor of pediatrics at the Medical College of Georgia and past-president and former Executive Medical Director of the American College of Allergy, Asthma, and Immunology. He has been a consultant for multiple companies manufacturing second generation antihistamines.

Resources:

FDA Drug Safety Communication on Cetirizine and Levocetirizine

ACAAI Advice on Speaking Points Regarding FDA Alert

Previous articles describing this side effect:

Unbearable Pruritus After Withdrawal of (Levo)cetirizine.

Pruritus after discontinuation of cetirizine.