Latest news with #Levocetirizine
Newsweek
21-05-2025
- Health
- Newsweek
FDA Issues Warning About Popular Allergy Medications
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The U.S. Food and Drug Administration has warned that patients who stop long-term use of the popular oral allergy medications Zyrtec or Xyzal may experience "rare but severe itching," in a May 16 warning. Newsweek reached out to Zyrtec and Xyzal's media teams via email for comment. Why It Matters In recent months, millions of Americans have grappled with seasonal allergies triggered by pollen and blooming plants. Many have reported sneezing, itchy eyes and runny noses, prompting a turn to prescription and over-the-counter allergy medications. According to the American College of Allergy, Asthma and Immunology, citing data from the Centers for Disease Control and Prevention (CDC), nearly one in three U.S. adults and more than one in four U.S. children report having a seasonal allergy, eczema or food allergy. The data showed that more than 100 million Americans reported having allergy symptoms. In 2021, approximately 81 million people in the U.S. had hay fever. In its warning, the FDA said that more than 80 million packages of the popular allergy medications were purchased in 2022. What To Know The FDA said that itching, known as pruritus, "has been reported in patients who used these medicines daily, typically for at least a few months and often for years." The patients did not have any itching symptoms prior to taking the allergy medications. The itching required medical intervention. The FDA said the symptoms "may improve with restarting the medicines." The agency is revising the prescribing information for the prescription versions of cetirizine (Zyrtec) and levocetirizine (Xyzal) to include a new warning about the risk. Cetirizine and levocetirizine are antihistamines that block histamines released by the body during allergic reactions. Both are approved to treat seasonal allergies. Cetirizine was approved as a prescription drug in 1995 and became available over the counter in 2007. Levocetirizine was approved for prescription use in 2007 and switched to over-the-counter status in 2017. The FDA's warning is based on 209 worldwide cases, 197 in the U.S., of pruritus after halting use of the drugs. The cases were reported to the FDA between April 25, 2017, and July 6, 2023. A man blows his nose behind birch pollen on the branch of a birch tree in Baden-W'rttemberg, Stuttgart, Germany, on April 3, 2025. A man blows his nose behind birch pollen on the branch of a birch tree in Baden-W'rttemberg, Stuttgart, Germany, on April 3, 2025. Bernd Wei'brod/picture-alliance/dpa/AP Images What People Are Saying A spokesperson for Opella, which owns Xyzal, told Newsweek: "Xyzal has a strong track record backed by scientific research and user satisfaction. We stand by the safety and efficacy of Xyzal when used as directed." The American Academy of Allergy, Asthma & Immunology, on X, formerly Twitter: "FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)" Zyrtec, on X: "The allergens are potent this year and normally we're a cut above!" What Happens Next The FDA advises patients to contact their health care providers if they develop severe itching after stopping their antihistamine use. Tree pollen typically peaks in April, while grass pollen emerges in late spring and continues through the summer months, usually from May to July.
News18
24-04-2025
- Health
- News18
Paracetamol, Ibuprofen May Soon Be Available At General Stores As India Reviews First List Of OTC Drugs
Last Updated: A committee has proposed that India needs to develop legal provisions, eligibility for considering drug as OTC and special labelling similar to those for prescription medicines A total of 27 prescription-only medicines, including levocetrizine, ibuprofen and paracetamol will soon be sold at medical and general stores as over-the-counter (OTC) drugs, News18 has learnt. The list of 27 drugs includes the names of generic formulations and the strength of doses allowed to be sold without a prescription. Currently, India lacks a comprehensive set of regulations governing the distribution, marketing, and consumption of OTC drugs. In May, drug regulator Central Drugs Standard Control Organisation (CDSCO) constituted a sub-committee to examine matters regarding the amendment of the Drugs Rules to incorporate necessary provisions for drugs to be declared as over-the-counter (OTC), in line with a recommendation of the Drugs Technical Advisory Board (DTAB) meeting. Now, the panel has submitted the report, and DTAB will deliberate to move on moving forward. 'The subcommittee has finely balanced and submitted the report containing almost 27 generic names of formulations for the top therapeutic segment. These formulations are top-selling and best in the safety profile of that category. For instance, Levocetirizine is best to treat allergies, ibuprofen is best for painkillers and paracetamol for anti-pyretic use," a senior official at the Ministry of Health and Family Welfare, privy to the development, told News18. The sub-panel has also mentioned the strength of the medicines which should be available in the OTC category. 'It would be damaging if people end up popping painkiller ibuprofen in higher doses. Hence, the idea is to keep the moderate or mild dose available without prescription." 'Legal provisions to be enabled under Drugs Rules, 1945 along with the manner of submitting application, requirements for considering a drug as an OTC, Labelling requirements, etc and incorporation of a separate Schedule as enumerated under section 7 of the report," said the government document containing agenda for discussion on upcoming DTAB meeting. The DTAB meeting is expected to convene in April. However, the final decision may take several meetings as the central government needs to design a full plan before it decides to shift prescription medicines into the OTC category. The sub-committee was headed by Dr Anupam Prakash, Director and Professor of Medicine, Lady Hardinge Medical College, Delhi. The panel has other members including as Dr Umesh D Suranagi from Director General of Health Services (DGHS), Paediatrician Dr Ratan Kumar Gupta from Vardhman Mahavir Medical College & Safdarjung Hospital and Dr Bikash Medhi, Department of Pharmacology, Post Graduate Institute of Medical Education & Research (PGIMER).
