Last Updated on December 31, 2023 by The Health Master
Drug alert
Download: DCGI dt 14-07-2023 Alert on Pholcodine containing cough and cold remedies, the link is given below: The Drugs Controller General (India) (DCGI) has taken a significant step in patient safety by issuing an advisory to doctors, healthcare professionals, and consumers regarding the discontinuation of the usage of pholcodine, an opioid medicine commonly employed in treating non-productive coughs in both adults and children.
This decision follows a medical product alert issued by the World Health Organization (WHO) and recommendations from the Subject Expert Committee (SEC) on antimicrobials and antivirals.
The WHO’s Anaphylactic Reactions Warning:
Earlier this year, the WHO alerted healthcare professionals and regulatory authorities about the potential risk of anaphylactic reactions in individuals who had consumed cough and cold remedies containing pholcodine at least 12 months before undergoing surgical procedures involving the administration of general anesthesia with neuromuscular blocking agents (NMBAs).
Advisory for Doctors and Healthcare Professionals:
In light of the WHO’s warning, the DCGI has advised doctors and healthcare professionals to take the following actions:
Recommend Alternative Treatments:
Advise patients to discontinue the use of pholcodine-containing cough and cold remedies and suggest alternative treatments for their symptoms.
Verification Process:
Verify whether patients scheduled to receive general anesthesia containing NMBAs have taken pholcodine-containing cough and cold remedies within the past 12 months.
Additionally, healthcare professionals should be vigilant about potential anaphylactic reactions in such patients.
Advisory for Consumers:
To ensure patient safety, the DCGI has issued the following advisory for consumers:
Cautionary Approach:
Exercise caution while using pholcodine-containing cough and cold remedies and consult a doctor or pharmacist for alternative treatment options.
Pre-Procedure Reporting:
If patients have taken pholcodine-containing cough and cold remedies in the previous 12 months and are scheduled to undergo general anesthesia, they should report this information to their doctor or healthcare professional before the procedure.
WHO’s Findings and European Commission’s Decision:
The WHO, in its medical product alert released on March 31, presented evidence suggesting that the use of pholcodine in the 12 months leading up to general anesthesia with NMBAs increases the risk of developing an anaphylactic reaction.
Based on the seriousness of this safety risk, the European Commission issued a legally binding decision across all EU Member States to withdraw pholcodine-containing products.
Many regulatory authorities globally have similarly withdrawn or restricted pholcodine-containing cough and cold remedies, and some have issued warnings to healthcare professionals and consumers.
Expert Opinion and DCGI’s Alert:
The matter was brought before the Subject Expert Committee (antimicrobial and antiviral) in a meeting on June 28, 2023, to seek expert opinion on the WHO’s safety alert regarding prior use of pholcodine-containing cough and cold remedies and the risk of perioperative anaphylactic reactions to NMBAs.
Based on the recommendations from the expert committee, the DCGI has issued the drug alert.
Conclusion:
In light of the potential risks associated with pholcodine use and the global regulatory responses, the DCGI’s advisory serves as a crucial measure to prioritize patient safety.
Several preparations containing pholcodine are commonly available as over-the-counter tablets and syrups, and both Indian companies and multinational pharmaceutical firms in India are selling drugs containing this ingredient.
Patients, healthcare professionals, and regulatory authorities are urged to act with caution and implement the recommended measures to safeguard patient well-being.
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