Some individuals may face a serious reaction when discontinuing two popular allergy medications. The U.S. Food and Drug Administration (FDA) has issued a warning regarding cetirizine (Zyrtec) and levocetirizine (Xyzal), indicating that those who cease their long-term use could experience “rare but severe itching,” a condition known as Pruritus.
This itching has been reported by users who took the medication daily for months or even years before stopping. Between April 25, 2017, and July 6, 2023, there were a total of 209 cases documented globally (197 of those in the U.S.). According to the FDA, this figure only accounts for reported cases, implying that there may be more out there.
“The reported incidents are infrequent but can be quite serious,” the agency cautioned, noting that patients might face significant itching that necessitates medical attention.
Many individuals reported that this condition had a meaningful and lasting impact on their quality of life and overall functionality. Fortunately, in about 90% of cases, restarting the medication effectively alleviated the severe itching. Some users (around 38%) managed to taper off gradually after resuming their treatment successfully.
Both medications are available in prescription and over-the-counter forms.
The FDA plans to revise the prescription details for these drugs to incorporate warnings about potential itching risks, and will also request manufacturers to update the Drug Facts label on the commercial versions.
Cetirizine and levocetirizine are antihistamines that the FDA has approved to treat seasonal allergies for both adults and children. Dr. Marc Siegel, a senior medical analyst and professor at NYU Langone Health, emphasized the effectiveness of these medications in easing allergic reactions.
Yet, he pointed out that stopping them suddenly after long-term usage could lead to severe itching due to an increased histamine release once the medication is halted.
The FDA recommends that anyone experiencing intense itching after stopping these medications should reach out to a healthcare professional. Those considering long-term use should discuss the pros and cons with their doctor to tailor advice to their specific needs.
Common side effects of cetirizine and levocetirizine include fatigue, sleepiness, dry mouth, and, in some cases, nausea and diarrhea.
In response to the FDA’s findings, a spokesperson for the Consumer Healthcare Products Association mentioned that consumer safety remains a priority, and they are supportive of the FDA’s mission to keep the public informed about even the rarest side effects. They also advised that anyone using these medications for extended periods should consult their healthcare provider before making any changes to their routine.
Opella, the manufacturer of Xyzal, stated that the drug has a solid safety record and noted that incidents like the one discussed are extremely uncommon when the medication is taken as instructed.
