Spurred by the medical alert issued by the global health agency, the panel suggested India’s drug regulatory agency, Central Drugs Standard Control Organization (CDSCO), issue a warning regarding the “cautious” use of the product. (Representative Photo/Shutterstock)
In March, the World Health Organization issued a warning amid concerns that pholcodine use could cause sudden and life-threatening allergic reactions in people who undergo general anesthesia before surgery up to a year afterward.
Soon, pholcodine-based cough syrups and flu medicines will come with a warning, News18 has learned. India’s medicines regulatory agency is seeking expert advice on whether to withdraw the products from the market, similar to measures taken by many other countries. Pholcodine, an opioid-based cough suppressant, has been tested in India after the World Health Organization (WHO) raised the alarm in March.
WHO had issued a warning amid concerns that pholcodine use can trigger sudden and life-threatening allergic reactions in people who continue to have a general anesthetic before surgery for up to a year afterward.
Spurred by the medical alert issued by the global health agency, the panel suggested that India’s drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO), issue a warning regarding the prudent use of the product.
Pholcodine suppresses cough by reducing the activity of the cough center in the brain. The product is also approved for use among children over the age of six.
The matter was referred for deliberation to the Committee of Subject matter Experts (SEC) which offered two recommendations to the Drug Controller General of India (DCGI) after a June 28 meeting.
The committee noted that there are various Pholcodine containing cough and cold remedies in the country’s market, the minutes of the meeting consulted by News18 said.
The committee after detailed deliberation recommended issuing a warning and setting up a group to suggest the way forward.
Issue an appropriate advisory by the CDSCO regarding the prudent use of pholcodine containing cough-and-cold remedies in the country based on the WHO alert it received, one of the SEC’s two recommendations said following the deliberation.
The other recommendation is to set up a sub-committee including subject matter experts from India’s Pharmacovigilance Program (PvPI), anesthesiology, pediatrics, surgery and internal medicine to recommend further courses of action.
The panel noted that some regulators have decided to withdraw pholcodine-containing products from their markets to address this risk.
To date, the minutes of the meeting said, some regulators have withdrawn prescription and over-the-counter preparations containing pholcodine from their markets. Several healthcare agencies that have recalled the products have been named such as Australias Therapeutic Goods Administration (TGA), United Kingdoms Medicines and Healthcare Products Regulatory Agency (MHRA) and Malaysias National Pharmaceutical Regulatory Agency (NPRA).
What does the WHO alert highlight?
The WHO alert has brought attention to a safety concern that has been identified with pholcodine-containing cough and cold remedies and the risk of perioperative anaphylactic reactions to neuromuscular blocking agents (NMBAs).
WHO through its news page had alerted healthcare professionals and regulatory authorities to the risk of anaphylactic reactions in people who had taken pholcodine-containing products at least 12 months before surgical procedures involving the administration of general anesthesia with neuromuscular blocking agents ( NMBA).
Findings in the UK study
A study by the British health regulator MHRA also found an increased risk of rare anaphylaxis in patients who had taken medicines containing pholcodine and subsequently received NMBA used in general anesthetics.
The UK Government advisory read: “Available data have shown that the use of pholcodine, particularly within the 12 months prior to general anesthesia with NMBA, is a risk factor for the development of an anaphylactic reaction to NMBA “.
Asked patients, tell your anesthetist before having surgery if you think you’ve taken pholcodine, particularly within the past 12 months, or think you’ve taken a product containing pholcodine. There is no increased risk of allergic reactions, including anaphylaxis, with other allergens following the use of pholcodine and the absolute risk in patients who have used pholcodine is very low, but patients should speak to a pharmacist, the their general practitioner or surgical team if they have any questions.
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