Chemists to take pholcodine cough medicines off shelves after WHO alert

DCGI issues advisory to doctors and patients after risks of anaphylactic reactions

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Sohini Das Mumbai

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Popular cough medicine brands are likely to go off shelves as India’s drug regulator cautions against the use of medicines containing an opiate called pholcodine.

The opiate has been linked to severe allergic reactions in people who undergo surgeries with general anaesthesia later on. These have manifested as drop in blood pressure, loss of blood circulation, abnormal rhythm of the heart, closing up of airways, and low oxygen levels.

Pholcodine is an opioid cough suppressant (antitussive) that is used for the management of dry cough in both children and adults.

The chemist’s lobby has asked its members — roughly 1.2 million retail chemists across the country — to advise patients to get a substation drug from their doctors in case anyone carries a prescription for a drug containing pholcodine.

Speaking to Business Standard, Rajiv Singhal, general-secretary of the All Indian Origin Chemists & Distributors (AIOCD), an umbrella organisation of chemists in the country, said AIOCD has issued an advisory to chemists against sharing brand names that contain pholcodine.

“According to the Drugs and Cosmetics Act, chemists cannot substitute a doctor’s prescription, and therefore, we have instructed our members to ask the patient to get a doctor substation. Chemists will soon start returning to companies the stock lying with them,” he said.

Singhal estimated that stocks worth Rs 10-12 crore would be in circulation in the market.

Companies, on their part, have started to discontinue the sales of such medicines. Mankind Pharma said its cough syrup Tedykoff has been discontinued since February.

The Drugs Controller General of India (DCGI) Rajeev Raghuvanshi issued an advisory to doctors, medical professionals, and patients using pholcodine-containing cough syrups and cold medication after the World Health Organization (WHO) raised an alarm on the safety of cough and cold remedies containing pholcodine.

WHO issued an alert to health care professionals and regulatory authorities, highlighting the risks of anaphylactic reactions associated with the prior 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 anaesthesia 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 in the matter,” the DCGI letter said.

The DCGI has asked doctors to advise patients to stop taking pholcodine-containing cough syrups and cold remedies and suggest an alternative to treat their symptoms.

“To verify whether the patients scheduled to take general anaesthetics (NMBAs) have taken pholcodine-containing cough syrups in the previous 12 months and also be aware of anaphylactic reactions in such patients,” Raghuvanshi said in the advisory.

He advised consumers/patients to ‘exercise caution’ when considering the use of pholcodine-containing cough and cold remedies and consult doctors or pharmacists for alternative treatment options.

“If you have taken pholcodine-containing cough and cold remedies within the past 12 months and are scheduled for a procedure involving general anaesthesia, it is essential to report this information to your health care professional before the procedure,” informed DCGI.

First Published: Jul 20 2023 | 7:33 PM IST

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