Article Summary:
The U.S. Food and Drug Administration (FDA) has issued a warning about a rare but severe side effect associated with long-term use of the common allergy medications cetirizine (Zyrtec) and levocetirizine (Xyzal). The FDA has found that patients who have used these medicines daily, typically for at least a few months and often for years, may experience severe and widespread itching (pruritus) after stopping the treatment. This side effect was not experienced before starting the medication.
The FDA has reviewed 209 cases worldwide, with 197 occurring in the United States between 2017 and 2023, which is a small fraction compared to the over 60 million packages sold of the two drugs. The underlying mechanism for this risk is unknown, but the FDA has concluded that there is a causal relationship between stopping cetirizine or levocetirizine and pruritus.
The FDA is revising the prescribing information for the prescription versions of these medications to include a warning about this risk and will request that manufacturers add a similar warning to the Drug Facts Label of the over-the-counter versions. Patients are advised to consult their healthcare providers if they experience severe itching after discontinuing long-term use of these allergy medications, and to report any such cases to the FDA’s MedWatch program.
Article Excerpt:
“FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine,” the administration announced May 16. The FDA “is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching.” The warning continued: “The itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years.