Warning Against the Use of Anti-Flu and Anti-Cold Drugs in Infants and Young Children
The Drug Controller General of India (DCGI) has recently issued a directive to the manufacturers of popular anti-flu and anti-cold combination drugs. This directive requires them to include a warning on their products, cautioning against the use of these medications in infants and children under the age of four.
The purpose of this warning is to ensure the safety and well-being of young children who may be at risk of experiencing adverse effects from these drugs. While these medications are commonly used to alleviate symptoms of the flu and cold, they may pose potential risks to the health of infants and young children.
Infants and young children have unique physiological characteristics that make them more susceptible to the side effects of certain medications. Their bodies are still developing, and their immune systems are not as robust as those of older children and adults. As a result, they may experience unexpected reactions or adverse effects when exposed to certain drugs.
By including the warning on the packaging of these anti-flu and anti-cold drugs, the DCGI aims to raise awareness among parents and caregivers about the potential risks associated with administering these medications to young children. It is crucial for parents to carefully read and follow the instructions provided by healthcare professionals and to consult with them before giving any medication to their children.
While these medications may be effective in relieving symptoms in older children and adults, they may not be suitable for infants and young children due to the potential risks involved. It is essential to prioritize the safety and well-being of young children and to explore alternative methods of managing their flu and cold symptoms.
Earlier in June, the government had banned 14 such FDC drugs, citing that there is no therapeutic justification for these medicines. A fixed dose combination is the combination of two or more drugs in certain fixed dosage combinations. If it were combined for the first time, it would fall under the definition of a new drug.
“Subsequently, concerns have been raised regarding the promotion of unapproved anti-cold drug formulations for infants,” the letter said.
The Subject Expert Committee (SEC) reviewed the combination of these two medications earlier in June in response to new concerns.
Finally, on 6 June, the Subject Expert Committee (Pulmonary) ruled, after carefully examining the drug’s usage in light of the concerns raised, that children under the age of four should not take the combination.
Noting this, DCGI has now decided that based on the recommendations of the SEC, manufacturers should “mention warnings in this regard on label and package insert and accordingly, the firms should mention a warning in this regard on label and package insert.”
“Accordingly, you are requested to direct all the manufacturers of said FDC under your jurisdiction to mention warning ‘FDC should not be used in children below four years of age’ on label and package insert/promotional literature of the drug,” it read.
Chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes, cough, runny nose, and sneezing. Phenylephrine also serves the same purposes such as temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, and bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.
Parents and caregivers should consider other non-pharmacological approaches to alleviate the discomfort caused by the flu and cold in infants and young children. These may include maintaining proper hydration, ensuring adequate rest, using saline nasal drops to relieve congestion, and providing a warm and comfortable atmosphere
If parents have any concerns or questions regarding the use of anti-flu and anti-cold drugs in young children, it is recommended that they consult with a healthcare professional. They can guide the appropriate treatment options for infants and young children, taking into consideration their unique needs and potential risks.
It is important to note that this warning does not imply that all anti-flu and anti-cold drugs are unsafe for infants and young children. Rather, it serves as a precautionary measure to inform parents and caregivers about the potential risks and to encourage them to exercise caution when considering the use of these medications.
In conclusion, the recent directive from the DCGI regarding the inclusion of a warning on anti-flu and anti-cold drugs for infants and young children is a significant step towards ensuring their safety. Parents and caregivers should be aware of the potential risks associated with these medications and should consult with healthcare professionals for guidance on appropriate treatment options. By prioritizing the well-being of young children, we can help create a safer and healthier environment for them.