3 min readJul 20, 2023 08:43 PM IST
First published on: Jul 20, 2023 at 05:10 PM IST
The Drugs Controller General of India (DCGI) has asked people to avoid the use of cough remedies that contain the opiate pholcodine as it has been linked to severe allergic reactions in people who undergo surgeries with general anaesthesia later on. This comes after the World Health Organisation (WHO) recommended the action based on evidence from Europe.
Pholcodine-containing syrups are most commonly available in India in combination with Promethazine, which is used for treating allergic conditions. Some of the common brands include Zytolix P by Klar, Teddykoff by Mankind, and Tussacron by Acron.
What does the Indian advisory say?
While the drug regulator has not withdrawn these products from the market, it has warned consumers to keep an eye out for pholcodine in their cough therapies and ask “the doctor or pharmacist to suggest an alternative treatment.” While the medicine is supposed to be sold on prescription in India, it is sometimes given over-the-counter by retailers as well.
The advisory also asks consumers to report any use of pholcodine medicines in the last 12 months to their doctor before undergoing any procedure requiring them to go under general anaesthesia. It also advises doctors and healthcare professionals to take history of pholcodine consumption in the past 12 months from patients who are to be given anaesthesia containing neuromuscular blocking agents.
Why should the syrup be avoided?
This advisory from the DGCI comes after a similar advisory issued by the WHO in March. The inter-government agency had issued the advisory considering the wide use, availability — without the requirement of prescription in many countries — and the seriousness of anaphylactic reactions.
The compound has been linked to increased risk of anaphylactic reactions up to 12 months after consumption when patients are given neuromuscular blocking agents that are used to paralyse patients during a surgery.
Anaphylactic reactions are a sudden life-threatening allergic condition. In patients undergoing surgery under the specific kinds of general anaesthesia, it resulted in symptoms such as drop in blood pressure, loss of blood circulation, abnormal rhythm of the heart, closing up of airways and low oxygen levels.
The decision was based on risk assessment by the European Medicines Agency using post-marketing safety data, information from healthcare professionals, and a French multi-centre study. The French study showed that people who had consumed pholcodine medicines in the past 12 months were more than four times at risk of these anaphylactic reactions.
Since then, all prescription and over-the-counter formulations that use pholcodine have been withdrawn by at least three national regulators — the Australian Therapeutic and Goods Administration, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, and the Malaysian National Pharmaceutical Regulatory Agency.
What is the medicine prescribed for?
Pholcodine is an opioid cough suppressant that is used for the management of dry cough in both children and adults.
Other cough suppressants — such as syrups containing Dextromethorphan
or those with herbal composition — may be used instead. However, doctors generally advise against the use of cough suppressants, especially in children, unless the coughing bout is extreme.
Pholcodine-containing syrups are most commonly available in India in combination with Promethazine, which is used for treating allergic conditions (Source: Getty Images) 
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