WHO Safety Concerns
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Centre Warns Against Cough Syrups Containing Pholcodine Following WHO Safety Concerns

The Drug Controller General of India (DCGI) has issued a warning against the use of cough syrups containing pholcodine in India, following a safety concern alert raised by the World Health Organisation (WHO) in March 2023.

Several countries have already banned the use of cough syrups with pholcodine due to the heightened risk of severe allergic reactions, including anaphylactic reactions, which can be life-threatening. The advisory comes as a measure to protect the health and well-being of patients and to ensure safer medical procedures.

Centre Warns Against Cough Syrups Containing Pholcodine Following WHO Safety Concerns

Centre Warns Against Cough Syrups Containing Pholcodine Following WHO Safety Concerns

The WHO’s Safety Concern Alert

The WHO highlighted a heightened risk of anaphylactic reactions in individuals who have taken cough syrups and cold remedies containing pholcodine at least 12 months prior to undergoing surgical procedures involving the administration of general anesthesia with neuromuscular blocking agents (NMBAs).

Anaphylactic reactions are severe allergic reactions that can be life-threatening, making it essential to address the safety concerns associated with the use of pholcodine.

The DCGI’s Advisory

In response to the WHO’s alert, the Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, issued an advisory to doctors, healthcare professionals, and consumers regarding the potential risks of pholcodine-containing cough syrups and cold remedies.

The advisory emphasized that several regulatory authorities worldwide have reviewed and either withdrawn or restricted the use of such products.

Why Pholcodine is Stricted ?

Pholcodine is restricted in certain countries due to safety concerns related to its potential interactions with neuromuscular blocking agents (NMBAs) during surgical procedures. The restriction is based on the World Health Organisation’s (WHO) safety concern alert, which highlights the heightened risk of anaphylactic reactions in individuals who have taken pholcodine-containing cough syrups and cold remedies at least 12 months prior to undergoing surgeries involving the administration of general anesthesia with NMBAs.

Expert Recommendations

The DCGI’s advisory was based on recommendations from the Subject Expert Committee (Antimicrobial and Antiviral) after a thorough evaluation of the WHO’s safety alert. Doctors, healthcare providers, and consumers were advised to exercise caution and consider alternative treatments for cough and cold symptoms.

It is essential to verify whether patients scheduled for surgeries requiring general anesthesia with NMBAs have taken pholcodine-containing cough and cold remedies in the past 12 months to mitigate the risk of anaphylactic reactions.

Expert Insights on Pholcodine Use

Dr. Saurabh Khanna, lead consultant in paediatrics and neonatology at CK Birla Hospital in Gurugram, explained that pholcodine use should be regulated to prevent harmful effects.

Excessive use of pholcodine in inappropriate doses or in individuals not recommended for its use can lead to severe anaphylactic reactions. He noted that pholcodine has been commonly used in various cough syrups available over-the-counter in India.

Side Effects and Caution

Aside from anaphylactic reactions, using pholcodine-containing cough syrups can lead to side effects such as constipation, drowsiness, gastrointestinal disturbances, nausea, vomiting, and respiratory depression in very high doses. To ensure safe usage, healthcare professionals should prescribe these syrups, and consumers must consult doctors or pharmacists for alternative treatments if needed.

Conclusion

The recent warning issued by the Drug Controller General of India serves as a precautionary measure against the use of cough syrups containing pholcodine, following the WHO’s safety concern alert. The risk of severe anaphylactic reactions is a matter of concern, necessitating the evaluation of alternative treatments for cough and cold symptoms.

Patients scheduled for surgical procedures involving general anesthesia with NMBAs should be closely monitored for any prior use of pholcodine-containing cough syrups. This advisory aims to protect the public’s health and promote safer healthcare practices across the country.

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