Cough medicines containing the chemical pholcodin should be banned because of the risk of life-threatening allergic reactions in people under general anaesthesia, the European Union’s medicines regulator has said.
The European Medicines Agency has recommended that treatments containing pholcodin, which is used in adults and children to treat dry cough, be withdrawn from sale.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, reports RTE.
Anaphylactic shock is a “sudden, severe and life-threatening allergic reaction” he added.
Medicines containing the chemical were “being withdrawn from the EU market and will therefore no longer be available by prescription or over the counter”, reports RTE.
According to RTE, The Department of Health said in Ireland that “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 alternative treatment options commonly available in Ireland that do not contain pholcodine.”
It advises that if you have taken pholcodine in the last 12 months and need general anesthesia, talk to your doctor and ask any questions you may have related to the link with an increased risk of severe allergic reactions to some drugs that may be used during the course. general anesthesia.
The Department of Health said: “he 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,” reports RTE.
The opioid pholcodine has been used as a cough medicine since the 1950s.
Medicines containing the chemical are currently authorized in the EU countries of Ireland, Belgium, Croatia, France, Lithuania, Luxembourg and Slovenia, under brand names including Dimethane, 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 dry cough was one of the main symptoms of the disease, the French authorities advised against the use of pholcodine syrups.
The EMA recommended in January updating the packaging to warn of the risk of allergies, based on new data.
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