FDA Requires New Warning on Common Allergy Drugs After Severe New Side Effect Found

The U.S. Food and Drug Administration has issued a warning that people who have used certain common allergy medications may experience a nasty, newfound side effect if they stop prolonged use of the drugs.

In an update titled, “FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine,” the administration announced May 16.

The FDA “is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching.”

The warning continued: “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.

“Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention.

“As a result, we are revising the prescription cetirizine and levocetirizine prescribing information to include a new warning about this risk.

“We will subsequently request that manufacturers add a warning about pruritus to the Drug Facts Label of the [over-the-counter] versions.”

Due to this dangerous new side effect, the FDA announced a swift move in the interim.

“We are adding a warning about the risk of pruritus after stopping long-term use of prescription cetirizine or levocetirizine to the prescribing information to increase awareness about this rare but serious reaction,” the administration noted.

The odds say that most people will not experience the pruritus side effect.

The FDA found 209 cases worldwide of this issue, with 197 being in the United States, between 2017 and 2023.

That total is a fraction of the over 60 million packages sold of the two drugs.

The FDA has yet to figure out the root of the issue.

“The underlying mechanism for this risk is unknown, but our evaluation supports a causal relationship between stopping cetirizine or levocetirizine and pruritus,” the FDA reported.

“Many reports described widespread pruritus that required medical intervention after stopping these medicines, with a large number describing significant and persistent impact on quality of life and ability to function.

“Most patients who experienced pruritus after medicine discontinuation reported using these medicines for more than 3 months; however, some experienced this reaction after less than 1 month of use.

“Restarting the medicine resolved pruritus in most individuals, and tapering off the medicine after restarting it resolved symptoms in some who tried this approach.

“Other than prolonged use, we have not identified any clear risk factors for pruritus after medicine discontinuation.”

If you think you are suffering from the pruritus side effect, the FDA urges either you or your doctor to also notify the FDA MedWatch program, which can be accessed via the FDA website through its “Contact FDA” tab.

Advertise with The Western Journal and reach millions of highly engaged readers, while supporting our work. Advertise Today.