The warning is crucial for India, where these over-the-counter drugs are commonly used to treat allergies and itching—conditions affecting millions due to high pollution levels and environmental triggers
Published Jun 18, 2025 | 7:00 AM ⚊ Updated Jun 18, 2025 | 7:00 AM
Synopsis: Millions of Indians using common antihistamines like cetirizine and levocetirizine may face severe withdrawal symptoms, as the U.S. FDA warns of rare but intense itching after prolonged use. The alert, based on 209 global cases, has major implications for India, where these drugs are widely used to treat allergies. The FDA stressed that some itching episodes required medical attention
Crores of Indians using common allergy medications may face severe withdrawal symptoms, as US health authorities issue urgent safety alerts about widely-available antihistamines.
The U.S. Food and Drug Administration issued a critical safety warning, alerting that patients who stop taking cetirizine or levocetirizine after prolonged use may experience rare but severe itching episodes requiring medical intervention.
The warning has significant implications for India, where these medications are widely prescribed and available over-the-counter for treating allergic rhinitis and seasonal allergies along with itching issues – conditions affecting millions across the country due to pollution and environmental factors.
The FDA identified 209 cases worldwide between 2017 and 2023 where patients experienced intense, widespread itching after discontinuing these commonly-used antihistamines. In the US alone, over 60 million packages were sold in 2022.
“Pruritus has been reported in individuals who used these medications daily, typically for several months and often for years,” the FDA stated. “Although rare, some cases have been severe, involving widespread and intense itching that required medical intervention.”
The investigation revealed alarming details about withdrawal severity. Among reported cases, 48 patients experienced disability from itching, with some describing “debilitating itching to the point of being bed-ridden.” Three required hospitalisation, and two reported suicidal thoughts due to intense symptoms.
Symptoms typically appeared within two days of stopping medication, with most cases occurring within one to five days. Patients using medications for longer periods faced higher risks, with median usage duration before withdrawal symptoms being 33 months.
Both cetirizine and levocetirizine are extensively prescribed in India for treating allergic rhinitis, seasonal allergies, and chronic hives. These antihistamines work by blocking histamine molecules released during allergic reactions and are approved for adults and children.
Many Indians rely on these medications long-term due to persistent pollution-related allergies and seasonal triggers. The drugs are readily available in pharmacies across the country without prescription requirements.
The FDA found that restarting medication resolved itching in 90 percent of affected patients, while gradual tapering helped 38 percent of those attempting this approach. However, 92 out of 93 patients who tried stopping and restarting experienced recurring symptoms.
“The underlying mechanism for this risk is unknown, but our evaluation supports a causal relationship between stopping cetirizine or levocetirizine and pruritus,” the FDA noted.
The warning raises important questions about long-term antihistamine use in India, where many patients self-medicate for chronic allergies. Healthcare experts suggest Indian medical authorities may need to review prescribing guidelines and patient education materials.
The FDA is updating prescribing information and requiring manufacturers to add warnings to over-the-counter labels. Health officials recommend patients planning long-term use discuss benefits and risks with healthcare professionals.
Indian patients currently using these medications are advised to consult their doctors before discontinuing treatment, especially if they have been taking them for several months or years. Those experiencing severe itching after stopping should seek immediate medical attention.
(Edited by Ananya Rao)
