FDA alert warns of rare but severe itching when discontinuing allergy drugs

The U.S. Food and Drug Administration (FDA) has issued a warning regarding two common allergy medications, cetirizine (Zyrtec) and levocetirizine (Xyzal), which could potentially cause a severe reaction in some individuals who stop using them. The alert highlights that patients who have been using these medications for an extended period of time may experience a rare but severe itching condition known as pruritus upon discontinuation.

According to the FDA, a total of 209 cases were reported worldwide, with 197 cases reported in the U.S. between April 25, 2017, and July 6, 2023. The severe itching reported by individuals who had been using these medications daily for months or even years led to a significant impact on their quality of life and ability to function. In most cases, restarting the medication resolved the itching, while some patients were able to taper off gradually after restarting.

Cetirizine and levocetirizine are antihistamines that are commonly used to treat seasonal allergies in both adults and children, as well as year-round allergies and chronic hives in patients as young as 6 months old. The FDA will be updating the medications’ prescribing information to include a warning about the risk of severe itching upon discontinuation. The manufacturers will also be adding this information to the drug facts label for over-the-counter versions.

Dr. Marc Siegel, a clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, emphasized the effectiveness of these medications in alleviating allergy symptoms and suggested that the severe itching upon discontinuation could be due to accelerated histamine release once the blocker is stopped. Individuals who experience severe itching after stopping these medications are advised to contact a healthcare professional.

Common side effects of cetirizine and levocetirizine include fatigue, drowsiness, cough, dry mouth, fever, sore throat, nosebleed, diarrhea, and vomiting. Patients planning on long-term use of these medications are encouraged to discuss the benefits and risks with their healthcare provider to receive personalized advice.

In response to the FDA alert, the Consumer Healthcare Products Association and the manufacturer of Xyzal, Opella, emphasized their commitment to consumer safety and compliance with FDA guidelines. Consumers who use these medications daily for an extended period should not abruptly stop taking them without consulting with their healthcare provider.

Overall, while cetirizine and levocetirizine are effective allergy medications, it is important for individuals to be aware of the potential risk of severe itching upon discontinuation and to seek medical advice if they experience this reaction.