New Delhi: The Central government has banned an anti-cold drug combination for use in children below the age of four.
Cough syrups with fixed drug combinations (FDCs) of chlorpheniramine maleate and phenylephrine hydrochloride have been restricted for sale, manufacture and distribution under-4 kids because of safety and health concerns.
These cough syrups help relieve itchy, watery eyes; sneezing; itchy nose or throat; runny nose caused by allergies, hay fever and common cold.
After examining the FDC of these syrups, the Drugs Technical Advisory Board and Subject Expert Committee have directed that the manufacturers will have to mention the warning ‘not to be used in children below four years of age’ on the label and package insert or the promotional literature of the drug.
“The Central government is satisfied that it is necessary and expedient in the public interest to regulate, by way of restriction, the manufacture for sale and distribution for human use of the said drug in the country,” read a gazette notification.
The notification further said that safer alternatives to the said drug combination are available.
Chlorpheniramine maleate may lead to allergic reactions, which can turn serious.
Among common side effects of Chlorpheniramine maleate are — dryness in mouth, sleepiness, nausea, trouble swallowing or throat tightness, swollen lymph nodes, swelling on the face, lips and mouth, and dizziness.
Chlorpheniramine has also been found to make it harder to empty the bladder in several children, especially if there is a blockage.
