FDA Flags Threat Tied to Common Allergy Med Zyrtec

Two frequent anti-allergy medicines 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 instances, trigger intense itchiness.

The FDA issued its warning earlier this month. Over the previous decade, the company has acquired a whole bunch of studies of individuals experiencing extreme—typically “debilitating”—itching after going off the medicines. Although it seems to be a uncommon complication, the FDA can be requiring producers to say the aspect impact within the labeling of those medication.

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

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

As helpful and protected as these medication have been for thousands and thousands of individuals, whispers of this aspect impact have been circulating for years. A 2019 research identified potential instances of extreme pruritus (itching) associated to cetirizine withdrawal relationship again to not less than 2008, as an example, whereas a 2016 research reported related instances within the Netherlands tied to levocetirizine; customers have additionally detailed their insufferable experiences attempting to stop these medication 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 medication, folks generally reported itching that hadn’t existed earlier than or to a level beforehand by no means skilled.

The FDA recognized 209 instances 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 medicines for over three months, usually years, although instances might additionally happen after just one month of steady use. Victims usually complained of widespread itching that required medical intervention; in some instances, 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 aspect impact appears to be uncommon general. The FDA notes that about 100 million prescriptions or OTC purchases of each medication mixed have been made in 2022. Folks with the aspect impact aren’t essentially doomed to itch ceaselessly, both. The FDA discovered that 90% of people that restarted their treatment resolved their itching, as an example, 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 aid after taking a brief course of corticosteroids.

Nonetheless, in the event you’re a longtime person of those medication, that is definitely one thing to pay attention to in case you ever determine to cease. Folks planning to take these medication long run also needs to talk about the advantages and dangers of doing so with their physician, the FDA mentioned, “who can present recommendation based mostly in your private wants.”