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Safety Advisory: Drug Regulator Set to Warn About Pholcodine in Cough Syrups

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Teena Thacker    11 July 2023

Indias drug regulatory authority is set to issue a warning urging caution in using cough and cold remedies containing Pholcodine. Recent concerns have emerged that these medications trigger life-threatening allergic reactions.

 

Pholcodine, an opioid cough suppressant, has a mild sedative effect and helps alleviate dry coughs. This ingredient is commonly found in various cough medications.

 

The World Health Organization (WHO) has already issued a safety alert, cautioning regulatory bodies worldwide about the potential risks of Pholcodine use. 

 

Consequently, several regulatory authorities, including the Therapeutic Goods Administration (TGA) in Australia, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia, have already withdrawn both prescription and over-the-counter preparations containing Pholcodine from their respective markets.

 

The drug regulators Subject Expert Committee (SEC) recently convened a meeting to discuss using cough and cold remedies containing Pholcodine and the associated risk of perioperative complications. 

 

(Source:https://health.economictimes.indiatimes.com/news/pharma/drug-regulator-to-issue-warning-against-pholcodine-in-cough-syrups/101650762 )

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