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.
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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.
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Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the complexity of manufacturing cellular therapies, which subjects us to a multitude of manufacturing risks, any of which could substantially increase our costs, delay our programs or limit supply of our product candidates; RMAT designation may not actually lead to faster development, regulatory review or approval process, and does not assure ultimate FDA approval; the effects of macroeconomic conditions, including the effects of disruption between the U.S. and its trading partners due to tariffs or other policies, any geopolitical instability and actual or perceived changes in interest rates and economic inflation; Lyell's ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell's limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; the nonclinical profiles of Lyell's product candidates or technology not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell's product candidates; the significant uncertainty associated with Lyell's product candidates ever receiving any regulatory approvals; Lyell's ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell's strategic plans for its business and product candidates; the sufficiency of Lyell's capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading 'Risk Factors' in Lyell's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on March 11, 2025, and Lyell's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, being filed with the SEC today. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law. Lyell Immunopharma, Selected Consolidated Financial Data(in thousands) Statement of Operations Data: Three Months Ended March 31, 2025 2024 Revenue $ 7 $ 3 Operating expenses: Research and development(1) 43,447 43,174 General and administrative 14,046 13,494 Other operating income, net (119 ) (1,090 ) Total operating expenses 57,374 55,578 Loss from operations (57,367 ) (55,575 ) Interest income, net 3,862 6,819 Other income, net(1) 1,310 1,090 Impairment of other investments — (13,001 ) Total other income (loss), net 5,172 (5,092 ) Net loss $ (52,195 ) $ (60,667 ) (1) As of October 1, 2024, the Company's success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2025 was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Fred Hutch success payment liabilities was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Balance Sheet Data: As of March 31, As of December 31, 2025 2024 Cash, cash equivalents and marketable securities $ 330,126 $ 383,541 Property and equipment, net $ 44,195 $ 48,200 Total assets $ 429,798 $ 490,859 Total stockholders' equity $ 336,521 $ 382,824 Non-GAAP Financial Measures To supplement our financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), we present non-GAAP net loss, non-GAAP R&D expenses and non-GAAP G&A expenses. Non‑GAAP net loss and non-GAAP R&D expenses exclude non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities from GAAP net loss and GAAP R&D expenses. Non-GAAP net loss further adjusts non‑cash investment gains and charges, as applicable. Non‑GAAP G&A expenses exclude non-cash stock-based compensation expense from GAAP G&A expenses. We believe that these non‑GAAP financial measures, when considered together with our financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare our results from period to period, and to identify operating trends in our business. We have excluded stock-based compensation expense, changes in the estimated fair value of success payment liabilities, and non-cash investment gains and charges from our non‑GAAP financial measures because they are non-cash gains and charges that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. We also regularly use these non‑GAAP financial measures internally to understand, manage and evaluate our business and to make operating decisions. These non-GAAP financial measures are in addition to, and not a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non‑GAAP financial measures have no standardized meaning prescribed by GAAP and are not prepared under any comprehensive set of accounting rules or principles and, therefore, have limits in their usefulness to investors. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business. Lyell Immunopharma, Reconciliation of GAAP to Non-GAAP Net Loss(in thousands) Three Months Ended March 31, 2025 2024 Net loss - GAAP $ (52,195 ) $ (60,667 ) Adjustments: Stock-based compensation expense 6,024 9,155 Change in the estimated fair value of success payment liabilities (125 ) 968 Impairment of other investments — 13,001 Net loss - Non-GAAP(1) $ (46,296 ) $ (37,543 ) (1) There was no income tax effect related to the adjustments made to calculate non-GAAP net loss because of the full valuation allowance on our net deferred tax assets for all periods presented. Lyell Immunopharma, Reconciliation of GAAP to Non-GAAP Research and Development Expenses(in thousands) Three Months Ended March 31, 2025 2024 Research and development - GAAP $ 43,447 $ 43,174 Adjustments: Stock-based compensation expense (2,388 ) (3,792 ) Change in the estimated fair value of success payment liabilities(1) — (525 ) Research and development - Non-GAAP $ 41,059 $ 38,857 (1) As of October 1, 2024, the Company's success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2025 was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Fred Hutch success payment liabilities was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Lyell Immunopharma, Reconciliation of GAAP to Non-GAAP General and Administrative Expenses(in thousands) Three Months Ended March 31, 2025 2024 General and administrative - GAAP $ 14,046 $ 13,494 Adjustments: Stock-based compensation expense (3,636 ) (5,363 ) General and administrative - Non-GAAP $ 10,410 $ 8,131 Contact:Ellen RoseSenior Vice President, Communications and Investor Relationserose@
