The U.S. Food and Drug Administration has issued a new warning for the allergy medicines cetirizine (Zyrtec) and levocetirizine (Xyzal), cautioning that patients who stop taking these drugs after long-term use may experience rare but severe itching.
New warning targets long-term users of allergy drugs
According to the FDA, patients who used cetirizine or levocetirizine daily—typically for months or even years—and then discontinued the medications have reported intense, widespread itching. The condition, known as pruritus, was not present before patients began the medications and has often required medical treatment.
In response, the FDA is updating the prescribing information for the prescription versions of these drugs and has requested similar warnings be added to the over-the-counter (OTC) labels.
Risk linked to both prescription and OTC use
- Cetirizine (Zyrtec) and levocetirizine (Xyzal) are popular antihistamines used to treat seasonal and year-round allergies as well as chronic hives.
- Most reported cases of post-discontinuation itching involved patients who had used the medications for more than three months.
- Pruritus typically began within two days of stopping the drugs.
- Restarting the medication relieved symptoms in 90% of cases where patients tried it.
In 2022 alone, U.S. consumers purchased an estimated 62.7 million OTC packages of these medications, and pharmacies dispensed 26.8 million prescriptions.
FDA urges awareness and consultation
The FDA advises patients to:
- Contact a healthcare professional if severe itching develops after stopping the medication.
- Discuss long-term use risks before starting cetirizine or levocetirizine, especially if planning to use it for several months or more.
Healthcare professionals are encouraged to discuss the potential for pruritus with patients, whether they are using prescription or OTC versions.
Rare, but serious
Between 2017 and 2023, the FDA received 209 reports of pruritus after patients stopped taking cetirizine or levocetirizine, with 197 cases in the U.S. Some cases were so debilitating that patients were bedridden or required hospitalization. Two individuals reported suicidal thoughts due to the severity of symptoms.
“Many reports described significant impact on quality of life and daily functioning,” the FDA stated.
Consumers and healthcare providers are encouraged to report adverse reactions through the FDA MedWatch program.
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