A Hyderabad paediatrician has cautioned against the OTC sale of allergy drops for infants, saying common droppers deliver adult doses. (Photo via Pexels)
Hyderabad paediatrician Dr Shivranjani Santosh, who first flagged sugary drinks falsely marketed as Oral Rehydration Solutions (ORS), has now raised concerns about over-the-counter (OTC) sale of cetirizine and levocetirizine drops for infants and children, whose dosage she feels is above safety limits.
Both these drugs are antihistamines or drugs that fight allergy by blocking the effects of histamine, a chemical your body releases in response to allergens. Both fall under Schedule H and are meant to be sold only on prescription.
Dr Santosh warns that the drops for infants are commonly dispensed with a 1 ml dropper containing 10 mg of the drug, effectively an adult dose. This high dose is harmful for infants as it can cause excessive drowsiness and shallow breathing, failing to remove enough carbon dioxide and deliver enough oxygen. Pointing to the lack of awareness among caregivers and weak enforcement at pharmacies, Dr Santosh argues that unrestricted access to Schedule H medicines undermines patient safety and puts children at risk. “There should be stricter regulation, clearer dosing safeguards and greater public awareness,” she says.
What does Schedule H classification mean?
Schedule H drugs are legally meant to be sold only against a doctor’s prescription because misuse can cause harm. When such medicines are sold over the counter, parents often assume they are harmless, which is not, particularly when administered to babies below six months of age.
What is the recommended dosage for cetirizine or levocetirizine in children?
These medicines should not be used in babies under six months. Even between six months and two years, they must be prescribed very judiciously. The maximum recommended dose is 2.5 mg per day, and per dose it should not exceed 2.5 mg, which translates to about 0.25 ml depending on the formulation.
What is the risk with commonly available dropper bottles?
Most of these drops come with a 1 ml dropper and parents don’t realize that 1 ml contains 10 mg of the drug, which is essentially an adult dose. If a caregiver gives 1 ml even once, or worse, multiple times a day, it can result in dangerous overdosing in infants.
What kind of harm can such overdosing cause?
These drugs have sedative properties. In babies, excessive doses can cause severe drowsiness and suppressed breathing. In extreme cases, if breathing slows or stops, it can be fatal.
Have parents reported adverse events to you?
I haven’t received formal complaints yet but in just one week, I saw two infants, one barely a month old and another three months old, who had been given these medicines. My concern is prevention. We’ve seen similar patterns earlier with cough syrups and antihistamine overdoses, and the consequences only become visible later.
Are newer antihistamines less sedating and does that make them safer?
While drugs like levocetirizine may be less sedating compared to older antihistamines, an adult dose given to a three-month-old baby is still dangerous. An infant’s body cannot metabolize drugs the way adults do.
Are these issues limited to one brand?
Multiple brands and equivalent formulations exist, and most of them contain 10 mg per ml. The problem is systemic — easy OTC access, identical droppers and lack of clear dosing awareness among caregivers.
What should parents do if their baby has cold or allergy-like symptoms and they can’t consult a doctor immediately?
Parents should not self-medicate. For a blocked nose, saline nasal drops can be used safely. If the baby is breathing fast, coughing continuously, vomiting or feeding poorly, they must consult a doctor.
What changes are you calling for?
Strict enforcement so that Schedule H drugs are not sold without prescription, no use in babies below six months, better packaging. Ideally, we must have droppers that do not allow more than 0.25 ml per dose, greater awareness among pharmacists and parents that these are not harmless medicines.
What is your key message to parents and policymakers?
Just because a medicine comes in drops or syrup form, it isn’t safe. Schedule H exists for a reason. Until we take prescription laws seriously, children, especially infants, remain at risk.