EMA recommends removal of cough syrup chemical

Cough medicines containing the chemical pholcodine should be banned due to the risk of potentially deadly allergic reactions in people under general anaesthetic, the European Union’s drug regulator has said.

The European Medicines Agency recommended that treatments containing pholcodine, which is used in adults and children to treat dry coughs, should be withdrawn from sale.

“Use of pholcodine in the 12 months before general anaesthesia … is a risk factor for developing an anaphylactic reaction” to muscle relaxants in the anaesthetic, the Amsterdam-based watchdog said.

Anaphylactic shock is a “sudden, severe and life-threatening allergic reaction”, it added.

Medicines with the chemical were “being withdrawn from the EU market and will therefore no longer be available by prescription or over the counter”.

It added: “Healthcare professionals should consider appropriate treatment alternatives and advise patients to stop taking pholcodine-containing medicines.”

The Department of Health said that in Ireland, “Day Nurse Capsules are the only currently available medicine which contains pholcodine. It is a medicine used to treat the symptoms of cold and flu and is available over the counter in pharmacies.

“There are many commonly available alternative treatment options in Ireland which don’t contain pholcodine.”

It advises that if you have taken pholcodine in the past 12 months and require general anaesthesia, talk to your healthcare professional and ask any questions you may have in relation to the link to an increased risk of severe allergic reactions to some medicines which may be used during general anaesthesia.

The Department of Health said: “The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines.

“The PRAC recommendation as announced by the European Medicines Agency today is the first step of the regulatory process to withdraw pholcodine containing medicines in the EU.

“The recommendation has been made following a review by the PRAC, in which the Health Products Regulatory Authority (HPRA) participated.

“This established that following use of pholcodine within the last 12 months, there is a link to an increased risk of severe allergic reactions to some medicines which may be used during general anaesthesia.

“This recommendation will now go forward to the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh), the next step in the regulatory process, at its next meeting in December 2022.

“The CMDh’s role in this process is to adopt an EU position in relation to the PRAC recommendation. The HPRA, as member of PRAC and CMDh, will continue its oversight of this issue.

“The Department of Health continues its governance of this issue at both national and European level.”

Opioid-based pholcodine has been used as a cough medicine since the 1950s.

Medicines containing the chemical are currently authorised in the EU countries of Ireland, Belgium, Croatia, France, Lithuania, Luxembourg and Slovenia, under brand names including Dimetane, Biocalyptol and Broncalene.

France had said in September that pholcodine could be banned due to the risk of allergies.

In April 2020, at the height of the Covid-19 pandemic, when a dry cough was one of the main symptoms of the disease, French authorities had recommended against the use of syrups with pholcodine.

The EMA in January had recommended updating packaging to warn of the risk of allergies, based on new data. RTÉ