FDA Flags Threat Tied to Well-liked Allergy Med Zyrtec

Two frequent anti-allergy drugs can depart you feeling scratchier than ever. The Meals and Drug Administration is warning that stopping long-term use of cetirizine and levocetirizine can, in uncommon circumstances, trigger intense itchiness.

The FDA issued its warning earlier this month. Over the previous decade, the company has obtained a whole bunch of reviews of individuals experiencing extreme—generally “debilitating”—itching after going off the drugs. Although it seems to be a uncommon complication, the FDA can also be requiring producers to say the facet impact within the labeling of those medicine.

“The underlying mechanism for this danger is unknown, however our analysis helps a causal relationship between stopping cetirizine or levocetirizine and pruritus,” the FDA stated in its Drug Security Communication in regards to the merchandise.

Cetirizine and levocetirizine are each antihistamine medicine which have been round for some time. The previous was first authorized because the prescription drug Zyrtec in 1995, whereas levocetirizine was authorized as Xyzal in 2007. Although the medicine can nonetheless be prescribed, they’re additionally now extensively accessible over-the-counter to deal with hay fever and different allergy signs.

As helpful and secure as these medicine have been for tens of millions of individuals, whispers of this facet impact have been circulating for years. A 2019 examine identified potential circumstances of extreme pruritus (itching) associated to cetirizine withdrawal courting again to no less than 2008, as an illustration, whereas a 2016 examine reported related circumstances within the Netherlands tied to levocetirizine; customers have additionally detailed their insufferable experiences attempting to stop these medicine on Reddit and different social media platforms lengthy earlier than the FDA stepped in. Whereas it’s potential some folks could have had a return of allergy signs as soon as they stopped taking these medicine, folks generally reported itching that hadn’t existed earlier than or to a level beforehand by no means skilled.

The FDA recognized 209 circumstances worldwide (197 within the U.S.) of new-onset pruritus after cetirizine/levocetirizine withdrawal between April 2017 and July 2023. Most individuals had taken the drugs for over three months, usually years, although circumstances may additionally happen after just one month of steady use. Victims sometimes complained of widespread itching that required medical intervention; in some circumstances, the itching was so extreme that it left folks bedridden and even led to ideas of suicide or self-harm.

The silver lining is that this facet impact appears to be uncommon total. The FDA notes that about 100 million prescriptions or OTC purchases of each medicine mixed have been made in 2022. Individuals with the facet impact aren’t essentially doomed to itch perpetually, both. The FDA discovered that 90% of people that restarted their remedy resolved their itching, as an illustration, and about one-third of individuals have been in a position to keep away from a brand new bout of itching in the event that they slowly weaned off the drug as soon as restarting. Some folks have additionally reported reduction after taking a brief course of corticosteroids.

Nonetheless, in the event you’re a longtime person of those medicine, that is definitely one thing to pay attention to in case you ever resolve to cease. Individuals planning to take these medicine long run also needs to focus on the advantages and dangers of doing so with their physician, the FDA stated, “who can present recommendation primarily based in your private wants.”