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 said Friday.
The European Medicines Agency (EMA) 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that treatments containing pholcodine — which is used in adults and children to treat dry coughs — should be withdrawn from sale.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Medicines with the chemical were “being withdrawn from the EU market and will therefore no longer be available by prescription or over the counter”.
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 Belgium, Croatia, France, Ireland, 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.
- Indonesian families sue government over cough syrup deaths, injuries
- Indonesia bans all syrup, liquid medicines after 99 child deaths
- Gambia says it has not yet confirmed cough syrup as cause of child deaths