As allergy season intensifies across the U.S., the Food and Drug Administration (FDA) has issued a new safety warning about an uncommon but potentially severe side effect tied to widely used allergy medications. On May 16, the FDA cautioned that long-term use of certain oral antihistamines may cause pruritus, a form of intense itching that can be medically serious.
The warning specifically concerns two drugs: cetirizine, sold under the brand name Zyrtec, and levocetirizine, marketed as Xyzal. Both medications are commonly used to treat seasonal allergies and are available over the counter and by prescription. The FDA noted that cases of severe itching have been reported among patients who took these medications daily for extended periods, typically several months to years.
While the cases are rare, the severity has prompted the agency to revise prescribing information for both drugs. “Some instances of pruritus were serious enough to require medical treatment,” the FDA stated in its advisory, encouraging consumers and healthcare providers to be vigilant when using these medications long-term.
Allergy Medications Drugmakers Respond to FDA Advisory
Following the FDA’s announcement, Opella, the company behind Xyzal, acknowledged the new safety warning while defending the drug’s overall safety profile. A spokesperson for Opella emphasized that Xyzal remains safe and effective when used as directed, citing “a strong track record backed by scientific research and user satisfaction.” The company reassured patients that this rare side effect does not undermine the benefits of the medication for most users.
Attempts to reach Kenvue, the manufacturer of Zyrtec, for comment were made, but no official response was available at the time of the warning. Despite this, both Zyrtec and Xyzal remain on the market, and consumers are urged to consult their healthcare providers if they experience unusual itching after prolonged use.
The warning does not apply to all users, and the FDA stresses that the medications are still safe for short-term or occasional use. However, individuals using them as part of long-term allergy management plans may want to reevaluate their treatment strategy with a physician.
Understanding Pruritus: When Itching Becomes a Medical Concern
The condition highlighted in the FDA warning, pruritus, is more than everyday itchiness. According to the Cleveland Clinic, pruritus can result from a variety of causes beyond dry skin, including inflammation, underlying health conditions, or nerve-related disorders. In the cases linked to cetirizine and levocetirizine, the itching reportedly began after discontinuation of the drugs, although it may also develop during use.
Pruritus can range in severity and, in rare instances, require prescription treatments or specialist care. Patients experiencing persistent or severe itching should seek medical advice, particularly if symptoms appear after stopping an allergy medication they have used long-term.
With millions relying on over-the-counter Allergy Medications antihistamines during peak allergy seasons, the FDA’s advisory serves as a reminder to remain alert to side effects and regularly review treatment plans with healthcare providers.
