DCGI warns against use of pholcodine-containing cough syrups, cites risks

Regulator asks doctors to suggest an alternative to patients for treating their symptoms

India’s drugs regulator has issued an advisory asking doctors, medical professionals and patients against using pholcodine-containing cough syrups and cold medication after the World Health Organization (WHO) raised an alarm.

The WHO’s advisory for healthcare professionals and regulatory authorities highlighted the risks of anaphylactic reactions associated with the use of pholcodine-containing products. The global agency said that people who have consumed pholcodine-containing cough and cold remedies within the last 12 months before undergoing surgical procedures involving general anesthesia with neuromuscular blocking agents (NMBAs) may be susceptible to severe allergic reactions.

“The matter was referred to the Subject Expert Committee (Antimicrobial & Antiviral) to seek expert opinion on the safety alert published by WHO on Prior use of pholcodine containing cough syrups and cold remedies and risk of perioperative anaphylactic reactions to NMBAS for any regulatory interventions required on the matter,” said the Drugs Controller General of India (DCGI), Rajeev Raghuvanshi.

The DCGI asked doctors to suggest an alternative to patients for treating their symptoms. “To verify whether the patients scheduled to take general anesthetics (NMBAS) have taken pholcodine containing cough syrups in the previous 12 months and also be aware of anaphylactic reactions in such patients,” he said in the advisory.

Raghuvanshi advised consumers or patients to "exercise caution" when considering the use of pholcodine-containing cough and cold remedies. “If you have taken Pholcodine-containing cough and cold remedies within the past 12 months and are scheduled for a procedure involving general anesthesia, it is essential to report this information to your healthcare professional prior to the procedure,” he said.