New Delhi : The Drugs Controller General (India) (DCGI) has issued an advisory to the doctors, healthcare professionals and consumers to stop usage of opioid medicine pholcodine, which is used in the treatment of non-productive coughs in adults and children, following a medical product alert from the World Health Organisation (WHO) and recommendation from the Subject Expert Committee on antimicrobials and antivirals.
The WHO, earlier this year, alerted healthcare professionals and regulatory authorities of the risk of anaphylactic reactions in people who have taken pholcodine containing cough and cold remedies at least 12 months prior to surgical procedures involving the administration of general anaesthesia with neuromuscular blocking agents (NMBAs).
The DCGI advised the doctors and healthcare professionals to advise patients to stop taking pholcodine containing cough and cold remedies and suggest an alternative to treat their symptoms. To verify whether the patient scheduled to take general anaesthetics containing NMBAs have taken pholcodine containing cough and cold remedies in the previous 12 months and also be aware of anaphylactic reactions in such patients.
The advisory to the consumers is to be careful in taking pholcodine containing cough and cold remedies and consult the doctor or pharmacist to suggest an alternative treatment. In case of patients who are going to take general anaesthetics and have taken pholcodine containing cough and cold remedies in the past 12 months should be reported to the Doctor or healthcare professional prior to the procedure, added the drug regulator.
The Who, in a medical product alert issued on March 31, said that the European Medicines Agency’s (EMA) pharmacovigilance risk assessment committee reviewed all available evidence including post-marketing safety data, information from third parties such as healthcare professionals and final results of a French multicentre case-control study comparing pholcodine exposure within a year before anaesthesia between patients with NMBA-related peri operative anaphylactic reactions.
“The available data showed that the use of pholcodine in the 12 months before general anaesthesia with NMBAs is a risk factor for developing an anaphylactic reaction (a sudden, severe and life-threatening allergic reaction) to NMBAs,” said WHO.
Based on the lack of effective measures to minimize the risk, the lack of an identified patient population for whom the benefits of pholcodine outweigh its risks, and the seriousness of the safety risk, the European Commission issued a legally binding decision applicable in all EU Member States to withdraw pholcodine containing products, it added.
“Further, many regulatory authorities have reviewed and withdrawn/restricted pholcodine containing cough and cold remedies. Some regulatory agencies have issued warnings to the healthcare professionals and consumers,” said the DCGI while issuing an alert against the drug.
The matter was referred to the SEC (antimicrobial and antiviral) in a meeting on June 28, 2023 to seek expert opinion on the safety alert published by WHO on prior use of pholcodine containing cough and cold remedies and risk of peri operative anaphylactic reactions to NMBAs for any regulatory intervention required on the matter.
It was based on the recommendation from the SEC, the DCGI has come forward with the drug alert, it added.
Several preparations are readily available and commonly used as over-the-counter tablets and syrups globally. Various Indian companies and multinational pharma firms in India are selling drugs which have pholcodine as an ingredient.
