Soon, pholcodine-based cough syrups and cold-flu medicines will come with a warning, News18 has learnt. The Indian drug regulatory agency is seeking an expert opinion on the possibility of withdrawing the products from the market, similar to the steps taken by several other countries. Opioid-based cough suppressant pholcodine has come under the scanner in India after the World Health Organization (WHO) raised an alarm in March.
The WHO had issued an alert amid concerns that the use of pholcodine can trigger sudden, life-threatening allergic reactions in people who go on to have a general anaesthetic before surgery up to a year later.
Driven by the medical alert issued by the global health agency, the panel of experts have suggested to the drug regulatory agency of India, Central Drugs Standard Control Organisation (CDSCO), to issue a warning regarding “cautious” use of the product.
Pholcodine suppresses cough by reducing the activity of the cough centre in the brain. The product is also approved for use among children above six years of age.
The matter was given for deliberation to the subject expert committee (SEC) which has offered two recommendations to the Drugs Controller General of India (DCGI) after a meeting on June 28.
“The committee noted that there are various Pholcodine containing cough and cold remedies in the market in the country,” minutes of the meeting accessed by News18 say.
The committee after detailed deliberation recommended the issuance of a warning and the creation of a panel to suggest the way ahead.
“To issue appropriate warning by CDSCO regarding cautious use of pholcodine containing cough and cold remedies in the country based on the WHO alert received,” said one of the two recommendations by the SEC following the deliberation.
The other recommendation is to “constitute a subcommittee including subject experts from Pharmacovigilance program of India (PvPI), anesthesiology, paediatrics, surgery and internal medicine to recommend further course of action”.
The panel noted that “…some regulatory authorities have taken decisions to withdraw pholcodine-containing products from their markets to address this risk”.
As of date, the minutes of the meeting said, some regulatory authorities have withdrawn prescription and over-the-counter preparations containing pholcodine from their markets. Multiple health agencies that have withdrawn products have been named such as Australia’s Therapeutic Goods Administration (TGA), the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), and Malaysia’s National Pharmaceutical Regulatory Agency (NPRA).
What does the WHO alert highlight?
The WHO’s alert has brought attention to a safety concern which has been identified with pholcodine-containing cough and cold remedies and the risk of perioperative anaphylactic reactions to neuromuscular blocking agents (NMBAs).
The WHO through its news page had alerted healthcare professionals and regulatory authorities of the risk of anaphylactic reactions in people who have taken pholcodine-containing products at least 12 months prior to surgical procedures involving the administration of general anaesthesia with neuromuscular blocking agents (NMBAs).
Findings in UK study
A study by UK’s health regulator MHRA also found an increased risk of rare anaphylaxis in patients who had taken medicines containing pholcodine and later received NMBAs used in general anaesthetics.
The UK government alert said, “The available data has demonstrated that pholcodine use, particularly in the 12 months before general anaesthesia with NMBAs, is a risk factor for developing an anaphylactic reaction to NMBAs.”
It asked patients, “Tell your anaesthetist before you have surgery if you think you have taken pholcodine, particularly in the past 12 months, or think you may have taken a pholcodine-containing product. There is no increased risk of allergic reactions, including anaphylaxis, with other allergens following pholcodine use and the absolute risk in patients who have used pholcodine is very small, but patients should talk to a pharmacist, their general physician or their surgical team if they have any questions.”
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