The Indian drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), banned the use of an anti-cold fixed drug combination for children under the age of 4.
This popular anti-cold fixed drug combination (FDC) is a combination of two drugs, chlorpheniramine maleate and phenylephrine.
This decision was made based on the suggestions of the Subject Expert Committee (SEC), which emphasizes that FDC should not be used for children under four years of age.
The FDC contains chlorpheniramine maleate and phenylephrine. While chlorpheniramine maleate is an anti-allergic drug, i.e., antihistamine, and phenylephrine acts as a decongestant.
The drug combination is used in the treatment of common cold, sinusitis, and allergies. It can help relieve symptoms such as a runny nose, sneezing, and nasal congestion, although this medicine will not treat an infection.
If you consume this drug formulation, the recommended dose shouldn’t be increased, as it could result in serious harm such as hallucinations, seizures, and death. Possible side effects of this drug combination could include allergic reactions like skin rashes, changes in vision, breathing issues, anxiety, a fast heartbeat, high or low blood pressure, and headaches. One should consult a doctor before consuming this fixed-drug combination.
All manufacturers of this common cold fixed-dose combination (FDC), containing chlorpheniramine maleate IP 2 mg with phenylephrine HCL IP 5 mg per ml drop, have been directed to include a warning on the label and the package about the caution: 'FDC should not be used in children below 4 years of age'.
The order by the regulator on the fixed-drug combination was issued on December 18 and made public on Wednesday.
"The committee recommended that the FDC should not be used in children below four years of age and accordingly, the firms should mention warnings in this regard on labels and package inserts. The recommendation of the SEC has been considered by this office," the letter stated.
"Accordingly, you are requested to direct all the manufacturers of said FDC under your jurisdiction to mention the warning 'FDC should not be used in children below 4 years of age' on the label and package insert/promotional literature of the drug," according to the DCGI's letter dated December 18.
This ban affects several pharma companies, including GlaxoSmithKline, Glenmark, Alembic Pharma, and IPCA Laboratories.
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References:
1. https://my.clevelandclinic.org/health/drugs/19537-chlorpheniramine-phenylephrine-oral-drops-solution (Visited on December 22, 2023)
2. https://www.webmd.com/drugs/2/drug-60/chlorpheniramine-phenylephrine-oral/details (Visited on December 22, 2023)
3. https://medicaldialogues.in/news/industry/pharma/cdsco-bans-use-of-chlorpheniramine-maleate-ip-2mg-and-phenylephrine-hcl-ip-5mg-dropml-fdc-in-kids-below-4-years-121935
(Input from various media sources)
(Rehash/Komal Bhoi)
