NETHERLANDS — The European Medicines Agency (EMA) has recommended that treatments containing pholcodine, which is used in adults and children to treat dry coughs, should be withdrawn from sale.
The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs).
“Use of pholcodine in the 12 months before general anesthesia… is a risk factor for developing an anaphylactic reaction” to muscle relaxants in the anesthetic, 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Medicines with the chemical were “being withdrawn from the EU market and will therefore no longer be available by prescription or over the counter.”
“Healthcare professionals should consider appropriate treatment alternatives and advise patients to stop taking pholcodine-containing medicines,” EMA said.
Used as a cough suppressant since the 1950s, pholcodine-containing drugs are authorized in Belgium, Croatia, France, Ireland, Lithuania, Luxembourg, and Slovenia.
Pholcodine is often used in combo with other drugs, made available as syrups, oral solutions, and capsules under various trade names and as generics, 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.
In a recent development, the World Health Organization (WHO) sounded alarm on four substandard India-made products typically used to treat cough symptoms in The Gambia, which was allegedly linked to scores of deaths in the West African country.
Haryana-based Maiden Pharmaceuticals ltd manufactured the four products — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
The products contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the global health body observed in an alert issued October 5, 2022.
The union government has reportedly initiated an investigation into the four products after it was informed about the issue by the WHO September 29.