Drug regulator issues warning against cold medication for children under 4 yrs

Manufacturers of the concerned FDC are now directed to prominently display a warning on both the label and package insert, as well as any promotional literature associated with the drug.

The Indian drug regulator, Central Drugs Standard Control Organisation(CDSCO), issued a warning against using a popular drug combination to treat cold infection for children aged below 4 years.

The Fixed Dose Combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml has come under scrutiny following concerns about its promotion as an anti-cold drug for infants.

During the Subject Expert Committee (SEC- Pulmonary) meeting in June 2023, concerns about the usage of the FDC in young children were thoroughly discussed. The committee recommended a precautionary measure, suggesting that the FDC should not be administered to children below 4 years of age. As a response to these safety considerations, the regulatory office has officially endorsed this recommendation.

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Earlier in 2015, the FDC was declared as rational by Professor Kokate’s Committee and based on the recommendation of the committee, the CDSCO office issued a No Objection Certificate (NOC) for continued manufacturing and marketing of the product.

Manufacturers of the concerned FDC are now directed to prominently display a warning on both the label and package insert, as well as any promotional literature associated with the drug. The warning explicitly states, "FDC should not be used in children below 4 years."

This proactive step aims to address potential risks associated with the use of the medication in young children, ensuring the safety and well-being of the target population. Manufacturers are urged to promptly implement this labelling update, and details of the action taken should be communicated to the regulatory office for record-keeping and further assessment.

It must be noted that earlier this year, the US Food and Drug Administration (FDA) reported that one of the abovementioned components, phenylephrine, does not work.

The US regulator’s independent Nonprescription Drugs Advisory Committee voted unanimously that orally administered phenylephrine is not as effective as a nasal decongestant at currently accepted dosage.  The committee said that phenylephrine is still effective in nasal sprays and drops, which are less commonly used.

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