2022-12-05| Trials & Approvals

EMA Urges Pholcodine’s Removal from European Market Following Safety Study

by Reed Slater
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After several companies collaborated on the ALPHO study to determine pholcodine’s link to anaphylactic reactions related to neuromuscular blocking agents (NMBAs), the European Medicines Agency (EMA) recommended the long-time cough suppressant be removed from the European market. Pholcodine is a common opioid cough suppressant used since the 1950s that many UK pharmacies sell over the counter. 

Analyzing More Than a Decade’s Worth of Safety Data

For many years, healthcare professionals expressed concerns over pholcodine’s potential link to anaphylactic reactions connected to NMBAs. However, the EMA had not seen any reason to revoke the drug from use until now.

In 2011, the EMA’s Committee for Medicinal Products for Human Use (CHMP) conducted a review of pholcodine’s safety profile and concluded there was not enough evidence to support a link between the drug and anaphylactic reactions. The regulatory agency stated pholcodine’s benefits continued to outweigh the risks.

The EMA changed its tune in recent days, though, after the Pharmacovigilance Risk Assessment Committee (PRAC) determined pholcodine’s risks do not outweigh its benefits and that the link between the drug and anaphylactic reactions is significant. Founded in 2012, the PRAC assesses risk management of human medicines and provides recommendations to CHMP, the EMA, and the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh). 

The ALPHO study, initiated in 2014, played a large role in the PRAC’s decision to recommend pholcodine’s withdrawal from European markets. Several key pharma players like GSK and Sanofi collaborated in the study to explore the link between pholcodine and perianaesthetic anaphylactic reactions related to NMBAs. The study found a definite link between pholcodine and perianaesthetic anaphylactic reactions. 

Related Article: FDA Revokes Authorization Of Eli Lilly’s COVID-19 Antibody

Where Pholcodine Goes From Here

A common dry-cough remedy for decades, countries worldwide have prescribed pholcodine to adults and children without cause for concern since the mid-twentieth century. In light of recent data, though, the drug’s use may shrink unless companies take preventative measures to minimize the drug’s risk of anaphylactic reactions. 

The EMA said healthcare professionals should stop prescribing or dispensing pholcodine or pholcodine-containing medicines to reduce the risk of perianaesthetic anaphylactic reactions. The regulatory agency also urged professionals to remain vigilant about patients scheduled to undergo anesthesia with NMBAs. It encouraged healthcare providers to be especially careful with patients who took pholcodine-containing medicines within the last 12 months. 

Despite pholcodine’s prevalence and historical significance, many alternatives exist to treat dry cough that do not carry the same risks as pholcodine. Going forward, healthcare providers across Europe may have to seek out those alternatives to treat patients suffering from dry cough. 

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