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Based on the medical alert issued by the WHO, the expert panel suggested to India’s drug regulatory agency, the Central Medicines Standards Control Organization (CDSCO), to issue a warning on ‘cautious’ use of the product. (representative image/Shutterstock)
In March, the World Health Organization issued an alert amid concerns that the use of pholcodine could lead to sudden, life-threatening allergic reactions in people who are under general anesthesia before surgery for up to a year later.
News18 soon learned that pholcodine cough syrup and cold medicine for the flu would come with a warning. India’s Medicines Regulatory Agency is seeking an expert opinion on the possibility of withdrawing products from the market, similar to steps taken by several other countries. The opioid-based cough suppressant Volcodin was put under the scanner in India after the World Health Organization (WHO) sounded an alert in March.
The World Health Organization has issued an alert amid concerns that the use of Volcodyne can lead to sudden, life-threatening allergic reactions in people who are under general anesthesia before surgery for up to a year later.
Based on the medical alert issued by the WHO, the expert panel suggested to India’s drug regulatory agency, the Central Drugs Standards Control Organization (CDSCO), to issue a warning on the ‘cautious’ use of the product.
Pholcodine suppresses cough by decreasing the activity of the cough center in the brain. The product is also approved for use among children over six years of age.
The matter was brought up for discussion before the concerned expert committee (SEC) which made two recommendations to the Narcotics Controller General of India (DCGI) after a meeting on June 28.
“The committee noted that there are several medicines containing Pholcodine for cough and cold treatment on the market in the country,” according to the meeting minutes accessed by News18.
The committee, after detailed deliberations, recommended issuing an alert and forming a committee to suggest ways forward.
“To issue an appropriate warning by CDSCO regarding the cautious use of Pholcodin containing cough and cold medications in the country based on the WHO alert received,” reads one of the two recommendations the SEC made after deliberations.
The other recommendation is to “form a sub-committee comprising subject matter experts from the Pharmacovigilance Program of India (PvPI), anesthesiology, pediatrics, surgery, and internal medicine to recommend a further course of action.”
The Committee noted that “… some regulatory authorities have taken decisions to withdraw products containing pholcodine from their markets in response to this risk”.
The minutes of the meeting stated that to date, some regulatory authorities have withdrawn prescription and over-the-counter formulations containing Volcodin from their markets. Several health agencies that have recalled the products have been named such as Australia’s Therapeutic Goods Administration (TGA), UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and Malaysia’s National Medicines Regulatory Agency (NPRA).
What does the WHO alert highlight?
The WHO alert drew attention to safety concerns identified with cough and cold medicines containing phelicodin and the risk of perioperative anaphylactic reactions to neuromuscular blocking agents (NMBAs).
The World Health Organization, through its news page, has warned healthcare professionals and regulatory authorities of the risk of allergic reactions in people who have taken pholcodine-containing products at least 12 months before surgical procedures involving the administration of general anesthetics with neuromuscular blocking agents (NMBAs).
Results in the UK study
A study by UK health regulator MHRA also found an increased risk of rare anaphylaxis in patients who took medicines containing pholcodine and subsequently received NMBAs used for general anesthesia.
The UK government alert said, “Available data have shown that the use of pholcodine, particularly in the 12 months preceding general anesthesia with NMBAs, is a risk factor for developing an anaphylactic reaction to NMBAs.”
I asked the patients, “Tell your anesthesiologist before surgery if you think you have taken pholcodine, especially in the past 12 months, or you think you have taken a product containing pholcodine. There is no increased risk of allergic reactions, including anaphylaxis Excessive exposure, with other allergens after use of Volcodin and the absolute risk in patients who have used Volcodin is very small, but patients should speak to their pharmacist, GP or surgical team if they have any questions.”
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