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FDA Issues Warning About Rare But Severe Reaction When Stopping Allergy Medications

Last updated: May 23, 2025 12:51 am
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FDA Issues Warning About Rare But Severe Reaction When Stopping Allergy Medications
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  • The FDA is issuing a warning about a rare but severe reaction that can happen when people stop taking certain allergy medicines

  • The uncomfortable side effect typically appears within a few days of stopping the medicine after long-term daily use

  • The FDA is updating the prescribing information for certain allergy medicines to include a new warning about the risk

The U.S. Food and Drug Administration is announcing a warning about a rare but severe reaction that can happen to people who stop taking oral allergy medicines like Zyrtec or Xyzal.

The agency said those who quit the medicines after long-term use can experience serious itching.

The uncomfortable side effect, also called “pruritus,” typically appears within a few days of stopping medicines like cetirizine (Zyrtec) or levocetirizine (Xyzal) after months to years of daily use, according to the FDA, which noted that patients did not experience itching before using the medications.

“Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention,” the FDA said on Friday, May 16.

The agency said that itching symptoms may get better when people start taking the allergy medicines again. Health officials are encouraging people to call their doctors if they develop severe itching after they stop taking allergy pills.

The FDA identified over 200 global cases of pruritus after stopping use of the medicines between April 2017 and July 2023, the agency shared. While an estimated 60 million-plus packages of the over-the-counter allergy meds were sold in 2022, the FDA noted, “Pruritus after medicine discontinuation appears to be rare compared to how often the medicine is used.”

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The FDA is updating the prescribing information for certain allergy medicines to include a new warning about the risk, and is requesting that manufacturers of the over-the-counter versions add a warning to the Drug Facts Labels. 

“In the meantime, we want to make the public aware of this risk.  We will follow up when additional information becomes available,” the FDA said.

A representative from Zyrtec reached over the phone told PEOPLE that they did not have any additional information to provide about the FDA warning.

A representative from Sanofi, the pharmaceutical company that makes Xyzal, told PEOPLE they were not allowed to provide any comments about the new warning over the phone. Sanofi did not immediately respond to an email request for additional information.

Read the original article on People

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