What’s the Issue?
On May 16, 2025, the FDA issued a Drug Safety Communication warning that discontinuation of cetirizine (Zyrtec) or levocetirizine (Xyzal)—after long-term, daily use—can cause rare but severe and widespread itching (pruritus), sometimes requiring medical attention. This risk applies to both prescription and over-the-counter (OTC) forms. U.S. Food and Drug AdministrationPeople.com
How Often Is This Occurring?
Between April 2017 and July 2023, the FDA logged 209 cases worldwide (197 in the U.S.) of pruritus following discontinuation—primarily in individuals who had taken these antihistamines daily for several months or years. Onset typically occurred within 1 to 5 days after stopping. U.S. Food and Drug AdministrationWikipedia
The FDA emphasizes the rarity of this reaction—especially when weighed against the tens of millions of packages sold annually. In 2022 alone, 62.7 million OTC packages were purchased, along with nearly 27 million prescriptions. U.S. Food and Drug AdministrationConexiant
Clinical and Consumer Impact
Patient Perspective
For most users, cetirizine and levocetirizine are well-tolerated and effective for treating conditions like seasonal allergies, perennial allergic rhinitis, and chronic urticaria—from ages as young as 6 months and 2 years, respectively. U.S. Food and Drug AdministrationWikipedia
However, for a small subset, suddenly stopping these medications can lead to intense itching—sometimes debilitating.
- Onset: Within days of discontinuation, even in individuals without prior itching issues.
- Resolution: Most cases improved upon restarting the medication or, in some instances, by gradually tapering off after restarting. U.S. Food and Drug AdministrationWikipedia
Healthcare Provider Guidance
Clinicians should:
- Warn patients about the small but real risk of pruritus during prescriptions or when recommending OTC use.
- Advise patients to report severe itching if it occurs soon after stopping the medicine.
- Restarting the medication or tapering may resolve symptoms, though evidence on tapering protocols is limited. U.S. Food and Drug Administration
FDA Action Plan
- Labeling Updates (Prescription Forms)
- Prescribing information must now include a clear warning on the risk of severe pruritus after discontinuation.
- Indicate that symptoms may improve with restarting or tapering the medication. U.S. Food and Drug Administration
- OTC Label Revision Request
- The FDA will ask OTC manufacturers to add warning language about pruritus to the Drug Facts Label.
- Communication and Monitoring
- Encourage patients and providers to stay informed and report adverse effects via FDA MedWatch.
- FDA may follow up with additional details as more information becomes available. U.S. Food and Drug Administration+1
What Manufacturers Need to Do
A. Update Prescription Labels
- Insert a new warning in both patient-facing and professional sections regarding the risk of severe itching after discontinuation.
- Provide guidance on symptom resolution with restarting or tapering.
B. Revise OTC Drug Facts Labels
- Add succinct, consumer-friendly alert about the potential for severe itching when stopping long-term use.
- Ensure visibility and clarity in the “Warnings” or “When to Stop Use” sections.
C. Enhance Pharmacovigilance
- Monitor for additional pruritus reports post-discontinuation using FAERS and other safety databases.
- Prepare to report trends or spikes to the FDA promptly.
D. Educate Consumers and Providers
- Issue Dear HCP and communication letters or updates to pharmacists and clinicians.
- Update consumer websites and FAQs to include information about this new risk.
- Train customer support teams to guide inquiries related to discontinuation symptoms.
Summary Table
| Stakeholder | Key Actions & Insights |
|---|---|
| Patients/Consumers | Be aware of rare itching after stopping; consult your provider if severe pruritus occurs. |
| Healthcare Providers | Inform patients of the risk; consider restarting or tapering if itching manifests. |
| Manufacturers | Update prescription and OTC labels; communicate changes clearly; enhance safety monitoring. |
Contextual Highlights
- Cetirizine and levocetirizine are widely used, effective, second-generation antihistamines, favored for their lower sedative potential. Verywell HealthWikipedia
- Despite their good safety record, post-marketing surveillance revealed this withdrawal-associated pruritus, prompting FDA intervention to ensure public safety. education.acaai.orgPeople.comEmpr
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