The FDA is issuing a new warning about a rare but “severe” risk associated with the long-term use of certain over-the-counter allergy medications.
The federal organization has revealed a newly uncovered side effect that may occur when stopping oral cetirizine (Zyrtec) or levocetirizine (Xyzal) after months to years of daily use. According to a new posting, some people who stopped using one or both of the drugs after regular, long-term use experienced “severe itching,” also called pruritus. Reported cases were rare but “sometimes serious,” with some patients “experiencing widespread, severe itching that required medical intervention.”
209 confirmed cases were identified worldwide, with the vast majority of them occurring in the United States. Reports were submitted to the FDA between April 25, 2017, and July 6, 2023. However, it’s unknown how many unreported cases may have occurred.
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Most of the patients were able to resolve their pruritus by restarting the medication, and others were able to wean themselves off the medication by tapering the dose without seeing the symptoms return. However, the underlying mechanism for the side effect has not been identified.
As a result, the FDA is now requiring a warning be added to the prescribing information when the medication is offered as a prescription, and will be requesting manufacturers add a warning about the risk to the Drug Facts Label on over-the-counter containers.
If you experience severe itching after stopping your prescription or OTC allergy medication—typically within a few days of your last dose—you should contact your doctor. If you’re planning on long-term use of either of the above drugs, you should also weigh the risks versus the benefits with your doctor.
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