Warning against cold and flu medicines for children under 4 years
Warning against cold and flu medicines for children under 4years
The drug combination of chlorpheniramine maleate and phenylephrine present in many OTC cough syrups and anti-allergic medicines will now have carry a warning, against its use for younger children.
As per the notification issued on 18 December by the CDSCO (Central Drugs Standard Control Organisation), the DCGI head, Rajeev Singh Raghuvanshi has written to drug controllers of all states and Union Territories (UT) that manufacturers should “mention warning ‘Fixed Dose Combination (FDC) should not be used in children below four years age’ on label and package insert/promotional literature of the drug”.
In June, govt banned 14 FDC drugs, saying that there was no therapeutic justification
The regulatory body addressed concerns regarding the promotion of an unapproved anti-cold drug formulation for infants, leading to a discussion and a subsequent recommendation against using the combination for the age group under 4years.
Chlorpheniramine maleate is an anti-allergic (antihistamine) drug which relieves allergy symptoms like runny nose, watery eyes and sneezing, phenylephrine is a decongestant which narrows the small blood vessels providing relief from congestion or stuffiness in the nose.
The Drug Controller General of India (DCGI) has asked the manufacturers of popular anti-flu and anti-cold combination drugs to carry a warning on these formulations against their use in infants and kids younger than four years of age.
Notably, the World Health Organisation does not recommend the use of over-the-counter cough syrups or medicines for treating coughs and cold symptoms in children under five years old.
