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What Is Pruritus? What the FDA Warning About Xyzal and Zyrtec Side Effects Means

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When that allergy season hits, it's normal to reach for your medication to try and get through your day. An FDA estimate says that 62.7 million over-the-counter packages of Zyrtec (cetirizine) and Xyzal (levocetirizine) were sold in 2022. We're now in an era where climate change is making for longer, more intense pollen seasons, which is partly responsible for allergies getting worse. The sales figures have likely climbed in the last three years, with worsened allergy symptoms like a runny nose, watery, red, itchy eyes and hives leading to more antihistamines being purchased.

You can find plenty of Reddit threads with folks discussing their allergies getting worse. Many users also discuss the right way to treat allergy symptoms. There's a solid amount of debate on how to use antihistamines and other medicines to reduce allergy symptoms.

If you're among the millions who take these drugs, you need to be aware that FDA recently published a warning about a newly discovered side effect from long-term use of both Zyrtec and Xyzal.

If you stop taking Zyrtec or Xyzal after long-term use, you might experience pruritus -- explained as "rare but severe" itching. This itching apparently showed up in patients who had been taking these allergy medicines every day for several months or years and then stopped.

What is the FDA going to do?

The FDA decided to issue this warning after identifying 209 cases worldwide -- 180 cases for cetirizine, 27 for levocetirizine and two for both -- of this particular side effect reported between April 2017 and July 2023. In the US, 197 cases were reported. However, there may be more, because these are only those that were reported to the FDA.

Interestingly, even though most patients who experienced this severe itching had been taking these antihistamines for more than three months, some had this reaction after less than one month of use.

Because of these findings, the FDA will now include a warning on the prescribing information for prescription cetirizine and levocetirizine. The administration is also asking that manufacturers add this warning to drug facts labels for OTC versions.

When to contact your doctor

If you stop taking OTC cetirizine or levocetirizine and develop severe itching within a few days after you've been using the medicine daily for several months to years, you should contact your doctor. If you plan to take these medicines for a prolonged period of time, you should also discuss the pros and cons with your doctor before starting.

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