Long-Term Use Linked to Severe Pruritus
Rare itching side effect prompts FDA warning on allergy drugs Zyrtec and Xyzal due to severe skin reactions reported.
This condition, known as pruritus, was found in patients who had been taking the drugs daily for months or even years. Although cases are uncommon, the itching has been severe enough in some instances to require medical attention.
Which Allergy Medications Are Involved?
The medications named in the FDA’s May 16 advisory include:
- Cetirizine (sold as Zyrtec)
- Levocetirizine (sold as Xyzal)
Both drugs are available over-the-counter or by prescription. The FDA has updated their prescribing labels to include a warning about potential pruritus following long-term use.
Pruritus: What Is It?
The medical word for severe skin itching is pruritus. Although it can be brought on by inflammation, dry skin, or nerve damage, the FDA is now connecting it to long-term use of some allergy drugs.
According to the Cleveland Clinic, pruritus can also result from internal conditions that affect the skin or organ systems.
Industry Response to the Warning
A spokesperson for Opella, the manufacturer of Xyzal, responded by reaffirming confidence in the drug’s safety.
“Xyzal has a strong track record of efficacy backed by scientific research and user satisfaction,” the company said. “We stand by its safety when used as directed.”
Zyrtec’s manufacturer, Kenvue, has not yet issued a public statement.
FDA’s Next Steps and Consumer Advice
Though the side effect is rare, the FDA urges consumers to:
- Monitor for new or unusual itching, especially if it continues after stopping the medication
- Speak with a healthcare provider before resuming the medication
- Report any severe reactions to the FDA’s MedWatch program
What Allergy Sufferers Should Know
With pollen levels peaking, millions of Americans turn to antihistamines like Zyrtec and Xyzal for relief. While effective, these drugs are now known to carry a small but serious risk if taken over long periods.
The FDA’s warning doesn’t suggest stopping these medications abruptly but does recommend caution, especially for those using them year-round.
Source: USA Today
