The U.S. Food and Drug Administration (FDA) has issued a significant warning regarding popular over-the-counter and prescription allergy medications, cetirizine (Zyrtec) and levocetirizine (Xyzal). Millions of users worldwide may experience a severe side effect: intense itching upon discontinuing these drugs, potentially worsening their symptoms rather than alleviating them.
FDA Issues Urgent Warning on Common Allergy Medications
The FDA has announced a critical update concerning cetirizine and levocetirizine, widely used to combat allergy symptoms. The agency has received reports of severe pruritus, or itching, occurring in patients after they stop taking these medications. This condition, which can be debilitating, has prompted the FDA to revise prescribing information and require new warnings on product labels.
Key Takeaways
- Medications Affected: Cetirizine (Zyrtec) and levocetirizine (Xyzal), available in both prescription and over-the-counter forms.
- Reported Side Effect: Severe, widespread itching (pruritus) upon cessation of the medication.
- User Profile: Typically affects individuals who have used the medications daily for at least a few months, often for years.
- Severity: Cases range from rare to serious, sometimes requiring medical intervention and significantly impacting quality of life.
- FDA Action: The FDA is updating prescription information and requiring manufacturers to add warnings to over-the-counter drug facts labels.
Understanding the Side Effect
The itching reported by patients typically manifests within a few days of stopping cetirizine or levocetirizine. While the exact mechanism causing this post-cessation pruritus is not fully understood, the FDA notes that many reports describe widespread itching that necessitated medical intervention. This severe itching can lead to skin damage, open sores, and significant distress, including difficulty sleeping.
Scope of the Issue
In 2022 alone, an estimated 62.7 million packages of over-the-counter cetirizine and levocetirizine products were purchased in the U.S. The FDA has identified 209 cases of pruritus linked to the cessation of these medications worldwide. However, this number likely represents an undercount, as it only includes reported cases.
Recommendations for Users
Patients who experience severe itching after discontinuing prescription or over-the-counter cetirizine or levocetirizine are advised to contact a healthcare professional. It is crucial for individuals to be aware of this potential side effect and seek medical guidance if they develop symptoms.