FDA Adds Warning to Commonly Used Allergy Medications

People who stop using Zyrtec or Xyzal after a long time may experience severe itching, the agency says.

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The Food and Drug Administration (FDA) is adding a new warning for two commonly used allergy medications after some users reported experiencing severe itching after discontinuing the drugs.

Some patients who stopped using cetirizine, known as Zyrtec, or levocetirizine, known as Xyzal, suffered severe itching, the FDA said in a May 16 safety alert.

“The itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years. Patients did not experience itching before starting the medicines,” the agency stated.

Of 209 cases identified around the world, 197 were in the United States. Two of the patients had been taking both of the drugs; the rest had been using one or the other.

The FDA described the reported cases as rare but said they were sometimes so serious that they required medical intervention.

The FDA said it is adding a warning about the risk of the severe itching to the prescribing information for Zyrtec and Xyzal. The agency is also requesting that the manufacturers of the medications add a warning about pruritus to the labels of the over-the-counter versions.

Johnson & Johnson, whose subsidiary McNeil Consumer Healthcare manufactures Zyrtec, did not respond to The Epoch Times’ request for comment by publication time.

“Xyzal has a strong track record backed by scientific research and user satisfaction. We stand by the safety and efficacy of Xyzal when used as directed,” a spokesperson for Opella, which manufactures Xyzal, told The Epoch Times via email.

According to the FDA, the updated information will say that the severe itching may ease if people resume taking the medications.

Both Zyrtec and Xyzal are antihistamines that block the histamine molecule that the body releases during allergic reactions. The FDA has approved the drugs to treat seasonal allergies. People ages 2 and older can take the medications for seasonal allergies. People ages 6 months and older can also take the drugs for year-round allergies and chronic hives.

The FDA originally approved Zyrtec in 1995 and began allowing it to be sold over the counter in 2007. Regulators approved Xyzal in 2007 and started letting it be sold over the counter in 2017.

If people experience severe itching after stopping use of one of the drugs, they should contact their doctor, the FDA advised.

“Individuals planning on long-term use of cetirizine or levocetirizine, especially for more than a few months, should discuss the benefits and risks with [their health] care professional, who can provide advice based on your personal needs,” the agency stated. “Health care professionals should discuss the risk of pruritus after stopping cetirizine or levocetirizine with patients when prescribing or recommending these medicines, especially if planned for chronic use.”

The FDA has not evaluated treatments for pruritus as of yet. One method that may be successful is resuming use of one of the drugs and tapering off the use after restarting it, according to the FDA.