India's DCGI warns against using cough remedies containing opiate pholcodine due to severe allergic reactions in individuals with general anesthesia. The WHO prompted the action, citing evidence from Europe.

Pholcodine-containing syrups are commonly found in India, usually combined with Promethazine, which is utilized to treat allergic conditions. Some of the well-known brands offering such combinations include Klar's Zytolix P, Mankind's Teddykoff, and Acron's Tussacron.

Indian Advisory Opinion

The drug regulator has not withdrawn these products from the market but has issued a warning to consumers. They are advised to be vigilant about the presence of pholcodine in their cough therapies and to consult the doctor or pharmacist for an alternative treatment if it is found. In India, the medicine is supposed to be sold on prescription; however, some retailers may provide it over-the-counter.

Consumers should report pholcodine use in the last 12 months to their doctor before general anesthesia procedures, and healthcare professionals should inquire about patients' pholcodine consumption history when administering anesthesia containing neuromuscular blocking agents.

Reasons to Avoid the Syrup

The DGCI issued an advisory following the WHO's March warning due to widespread use and availability of the compound without prescription, as well as the risk of anaphylactic reactions.

Consumption of the compound has been linked to an increased risk of anaphylactic reactions for up to 12 months after usage, particularly when patients are administered neuromuscular blocking agents during surgery, which are used to paralyze patients.

Anaphylactic reactions are sudden and life-threatening allergic conditions. In patients undergoing surgery with specific types of general anesthesia, these reactions resulted in symptoms such as a drop in blood pressure, loss of blood circulation, abnormal heart rhythm, closure of airways, and low oxygen levels.

The European Medicines Agency based on risk assessment and a French multi-center study found that individuals who had consumed pholcodine medicines within the past 12 months were at over four times higher risk of experiencing anaphylactic reactions.

Consequently, at least three national regulators, namely the Australian Therapeutic and Goods Administration, the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and the Malaysian National Pharmaceutical Regulatory Agency, have since withdrawn all prescription and over-the-counter formulations containing pholcodine.

Why is the Medicine Prescribed?

Pholcodine, an opioid cough suppressant, finds application in managing dry cough in both children and adults.

Instead, doctors typically recommend alternatives like syrups containing Dextromethorphan or those with herbal composition for cough suppression. However, the general advice is to avoid using cough suppressants, especially in children, unless the coughing is extremely severe.