Latest news with #cetirizine
CNET
a day ago
- General
- CNET
The FDA Warns of New Zyrtec and Xyzal Side Effect. What Is Pruritus?
According to the FDA, 62.7 million over-the-counter packages of Zyrtec (cetirizine) and Xyzal (levocetirizine) were purchased in 2022. Since allergies are getting worse -- partly because of climate change creating longer, more intense pollen seasons -- these numbers have likely climbed in the last three years as more people purchase the antihistamines to cope with allergy symptoms like a stuffy nose, watery, red, itchy eyes and hives. For the millions of people who take these drugs, it's important to know that the FDA recently published a warning about a newly discovered side effect that may occur after taking both Zyrtec and Xyzal. If you stop taking Zyrtec or Xyzal after long-term use, you might experience "rare but severe" itching. Also called pruritus, this itching was experienced by 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. How to treat this new Zyrtec and Xyzal side effect According to the FDA, no effective treatments for pruritus have been found. However, most patients discovered that their symptoms resolved after they restarted cetirizine or levocetirizine or after they tapered off the antihistamine after restarting it. Before you try this, consult your doctor to make sure that's the best course of action if you think you're dealing with this Zyrtec or Xyzal complication. According to the FDA, the most common, already-known side effects of cetirizine and levocetirizine are fatigue, drowsiness, sore throat, cough, dry mouth, nosebleed, fever, diarrhea and vomiting. What is pruritus? Plus, additional symptoms to know The Cleveland Clinic reports that pruritus is the medical term for "itchiness." It can be painful or irritating and spread to multiple areas of the body. Other symptoms of pruritus can include a rash, blisters, large bumps, small pimple-like bumps and skin discoloration. Scratching the skin can cause additional symptoms, such as skin breaks and bleeds, scratch marks, dry or cracked skin, broken skin that leaks a yellow to white fluid (infection), localized pain where the skin itches and a thick, leathery patch. That is why it's important to do what you can to manage your itching under the care of a doctor. Dry skin, pregnancy, contact with an allergen and a reaction medication are common causes of pruritus. If it occurs for over six weeks, it can be considered chronic.
Gizmodo
3 days ago
- General
- Gizmodo
Stop Using, Start Itching: FDA Flags Risk Tied to Popular Allergy Med Zyrtec
Two common anti-allergy medications can leave you feeling scratchier than ever. The Food and Drug Administration is warning that stopping long-term use of cetirizine and levocetirizine can, in rare cases, cause intense itchiness. The FDA issued its warning earlier this month. Over the past decade, the agency has received hundreds of reports of people experiencing severe—sometimes 'debilitating'—itching after going off the medications. Though it appears to be a rare complication, the FDA is also requiring manufacturers to mention the side effect in the labeling of these drugs. 'The underlying mechanism for this risk is unknown, but our evaluation supports a causal relationship between stopping cetirizine or levocetirizine and pruritus,' the FDA stated in its Drug Safety Communication about the products. Cetirizine and levocetirizine are both antihistamine drugs that have been around for a while. The former was first approved as the prescription drug Zyrtec in 1995, while levocetirizine was approved as Xyzal in 2007. Though the drugs can still be prescribed, they're also now widely available over-the-counter to treat hay fever and other allergy symptoms. As useful and safe as these drugs have been for millions of people, whispers of this side effect have been circulating for years. A 2019 study identified potential cases of severe pruritus (itching) related to cetirizine withdrawal dating back to at least 2008, for instance, while a 2016 study reported similar cases in the Netherlands tied to levocetirizine; users have also detailed their unbearable experiences trying to quit these drugs on Reddit and other social media platforms long before the FDA stepped in. While it's possible some people may have had a return of allergy symptoms once they stopped taking these drugs, people commonly reported itching that hadn't existed before or to a degree previously never experienced. The FDA identified 209 cases worldwide (197 in the U.S.) of new-onset pruritus after cetirizine/levocetirizine withdrawal between April 2017 and July 2023. Most people had taken the medications for over three months, often years, though cases could also occur after only one month of continuous use. Sufferers typically complained of widespread itching that required medical intervention; in some cases, the itching was so severe that it left people bedridden or even led to thoughts of suicide or self-harm. The silver lining is that this side effect seems to be rare overall. The FDA notes that about 100 million prescriptions or OTC purchases of both drugs combined were made in 2022. People with the side effect aren't necessarily doomed to itch forever, either. The FDA found that 90% of people who restarted their medication resolved their itching, for instance, and about one-third of people were able to avoid a new bout of itching if they slowly weaned off the drug once restarting. Some people have also reported relief after taking a short course of corticosteroids. Still, if you're a longtime user of these drugs, this is certainly something to be aware of in case you ever decide to stop. People planning to take these drugs long term should also discuss the benefits and risks of doing so with their doctor, the FDA said, 'who can provide advice based on your personal needs.'
CNET
28-05-2025
- Health
- CNET
The New Zyrtec and Xyzal Side Effect: How to Treat It and When to Contact Your Doctor
Allergies are, in fact, getting worse. That would explain why common allergy medications like Zyrtec (also called cetirizine) and Xyzal (levocetirizine) fly off drugstore shelves every year to treat allergy symptoms like a runny nose, itchy eyes and even hives. However, if you take these drugs, there is something you should know: The FDA recently published a warning about a newly discovered side effect that may occur with both Zyrtec and Xyzal. If you stop taking Zyrtec or Xyzal after long-term use, you may experience rare but severe itching. Also called pruritus, this itching was experienced by patients who were taking these allergy medicines every day for several months or years. The FDA estimates that 62.7 million over-the-counter packages of cetirizine and levocetirizine were bought in 2022. In the same year, about 26.8 million cetirizine and levocetirizine prescriptions for OTC and prescription products were dispensed from US outpatient pharmacies. Considering that allergies are getting worse -- partly because of climate change creating longer, more intense pollen seasons -- it wouldn't be surprising if these numbers continue to climb. 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. How to treat this new Zyrtec and Xyzal side effect According to the FDA, no effective treatments for pruritus have been found. However, most patients discovered that their symptoms resolved after they restarted cetirizine or levocetirizine or after they tapered off the antihistamine after restarting it. Before you try this, consult your doctor to make sure that's the best course of action if you think you're dealing with this Zyrtec or Xyzal complication. According to the FDA, the most common, already-known side effects of cetirizine and levocetirizine are fatigue, drowsiness, sore throat, cough, dry mouth, nosebleed, fever, diarrhea and vomiting. What is pruritus? Plus, additional symptoms to know The Cleveland Clinic reports that pruritus is the medical term for "itchiness." It can be painful or irritating and spread to multiple areas of the body. Other symptoms of pruritus can include a rash, blisters, large bumps, small pimple-like bumps and skin discoloration. Scratching the skin can cause additional symptoms, such as skin breaks and bleeds, scratch marks, dry or cracked skin, broken skin that leaks a yellow-to-white fluid (infection), localized pain where the skin itches and a thick, leathery patch of skin. That is why it's important to do what you can to manage your itching under the care of a doctor. Dry skin, pregnancy, contact with an allergen and a medication reaction are common causes of pruritus. If it occurs for over six weeks, it can be considered chronic.
CNET
24-05-2025
- Health
- CNET
The FDA Warns of New Zyrtec and Xyzal Side Effect. Here's What We Know About Treating It
Tens of millions of over-the-counter and prescription packages of cetirizine (Zyrtec) and levocetirizine (Xyzal) are purchased every year for seasonal allergies, year-round allergies and chronic hives. However, the FDA just released a warning about a new potential side effect that can occur with both medications. If you stop taking Zyrtec or Xyzal after long-term use, you may experience rare but severe itching. Also called pruritus, this itching was experienced by patients who were taking these allergy medicines every day for several months or years. According to the FDA, the most common, already-known side effects of cetirizine and levocetirizine are fatigue, drowsiness, sore throat, cough, dry mouth, nosebleed, fever, diarrhea and vomiting. The FDA estimates that 62.7 million over-the-counter packages of cetirizine and levocetirizine were bought in 2022. In the same year, about 26.8 million cetirizine and levocetirizine prescriptions for OTC and prescription products were dispensed from US outpatient pharmacies. Considering that allergies are getting worse -- partly because of climate change creating longer, more intense pollen seasons -- it wouldn't be surprising if these numbers continue to climb. 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. How to treat this new Zyrtec and Xyzal side effect According to the FDA, no effective treatments for pruritus have been found. However, most patients discovered that their symptoms resolved after they restarted cetirizine or levocetirizine or after they tapered off the antihistamine after restarting it. Before you try this, consult your doctor to make sure that's the best course of action if you think you're dealing with this Zyrtec or Xyzal complication.
Fox News
23-05-2025
- Health
- Fox News
Popular allergy medications linked to severe withdrawal symptoms, FDA warns
Two common allergy medications could cause a severe reaction in some people who stop using it. The U.S. Food and Drug Administration (FDA) issued an alert related to cetirizine (Zyrtec) or levocetirizine (Xyzal), warning that patients who stop taking it after long-term use may experience "rare but severe itching," a condition called pruritus. The itching was reported by people who used the medicines every day for months or years, and then stopped using them. In total, 209 cases were reported worldwide (197 in the U.S.) between April 25, 2017, and July 6, 2023. "This number includes only reports submitted to FDA, so there may be additional cases of which we are unaware," the agency stated in the release. "Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention." Many reports described a "significant and persistent impact on quality of life and ability to function," the FDA noted. In most cases (90%), restarting the medicine resolved the severe itching. Some (38%) had success with gradually tapering off after restarting. The drugs are available in both prescription and over-the-counter versions. "I suspect this might be due to accelerated histamine release once the blocker is stopped." The FDA said it will update the medications' prescribing information to include a warning of the itching risk, and will also ask the manufacturers to add the information to the drug facts label for over-the-counter versions. Cetirizine and levocetirizine are antihistamines that are approved to treat seasonal allergies in adults and children 2 and up, according to the FDA. The drugs are also approved as a treatment for year-round allergies and chronic hives in patients 6 months and older. People who experience severe itching after the cessation of these medications should contact a healthcare professional, the FDA advised. "Individuals planning on long-term use of cetirizine or levocetirizine, especially for more than a few months, should discuss the benefits and risks with your healthcare professional, who can provide advice based on your personal needs," the agency stated. Other common side effects of cetirizine and levocetirizine include fatigue, drowsiness, cough, dry mouth, fever, sore throat, nosebleed, diarrhea and vomiting, per the FDA. Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, noted that these medications are "very effective" at alleviating allergy symptoms. "The FDA is noting that in extremely rare circumstances after long-term use, stopping them can lead to severe itching, which is alleviated after restarting them," he reiterated to Fox News Digital. "I suspect this might be due to accelerated histamine release once the blocker is stopped." A spokesperson from the Consumer Healthcare Products Association provided the below statement to Fox News Digital. "Consumer safety is the top priority for CHPA and our manufacturer members. The OTC industry supports FDA's ongoing commitment to notifying the public about safety signals, even when extremely rare, as in this case." "CHPA members will continue to comply with FDA guidelines, including any needed updates to Drug Facts labels, while also evaluating and monitoring the latest science and product profiles. Consumers who use these medicines daily for an extended period (months-years) should not stop taking their medication abruptly without first consulting with their healthcare provider." For more Health articles, visit Opella, the manufacturer of Xyzal, shared the below statement with Fox News Digital. "Xyzal has a strong track record of safety and efficacy backed by scientific research and user satisfaction. This is a rare reaction, and Opella stands by the safety of Xyzal when used as directed."
