The U.S. Food and Drug Administration (FDA) has issued a warning about a rare but serious side effect linked to two widely used allergy medications—cetirizine (brand name Zyrtec) and levocetirizine (Xyzal).
According to the FDA, some people who stop taking these antihistamines after long-term use may experience severe itching, known medically as pruritus. This reaction has occurred with both prescription and over-the-counter versions of the medications.
As a result, the FDA is requiring manufacturers to add warning labels to the packaging of these drugs. Pharmacists will also be required to include the new information when dispensing them. The updated labeling will note that restarting the medication may relieve the itching.
More Than 200 Cases Reported
The FDA received over 200 reports of patients developing widespread and intense itching after stopping the medications. These individuals had been taking the drugs daily, often for months or even years, and did not experience itching before using them. In some cases, the side effect was so severe that it significantly disrupted patients’ quality of life and required medical treatment.
What These Medications Do
Cetirizine and levocetirizine are antihistamines used to treat seasonal and year-round allergies, as well as chronic hives. They work by blocking histamine, a substance the body releases during allergic reactions that can cause symptoms like sneezing, itching, and swelling.
What to Do If You Experience Itching
If you develop extreme itching after stopping long-term use of cetirizine or levocetirizine, the FDA advises contacting a healthcare provider. The issue came to light through reports in the FDA’s Adverse Event Reporting System.
The agency also recommends that anyone planning to use these medications for an extended period—particularly longer than a few months—should speak with a doctor to weigh the risks and benefits.
While the reaction is rare, individual responses to medication can vary based on personal health, genetics, and other medications being taken. The FDA notes it cannot predict who will be affected.
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