Here are the cough and cold medicines that can no longer be sold according to the EMA
The EMA has recommended stopping the sale of some medicines used in both adults and children for the treatment of coughs, colds and flu. What medicines are these and why?
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended the revocation of the marketing authorizations in the European Union for some medicines used in both adults and children for the treatment of dry cough and, in combination with other active ingredients, for the treatment of cold and flu symptoms.
The products involved are those containing pholcodine.
THE DECISION OF THE EMA
The Prac, the EMA body that is responsible for evaluating all aspects of risk management of medicines for human use, following the review of medicines containing pholcodine, has recommended the revocation of their marketing authorizations in the EU.
During the review, says the Italian Medicines Agency (Aifa), the Prac evaluated all available evidence, including the final results of the ALPHO Study, post-marketing safety data and information provided by third parties, such as healthcare workers.
WHY STOP FOLCODINA
The Committee noted that the available data showed that the use of pholcodine within 12 months prior to general anesthesia with neuromuscular blocking agents (NMBAs) is a risk factor for the development of an anaphylactic reaction (a sudden allergic reaction, severe and potentially life-threatening) to NMBAs.
As it has not been possible to identify effective measures to minimize this risk, nor to identify a patient population in which pholcodine's benefits outweigh its risks, pholcodine-containing medicines have been withdrawn from the market in the EU and will therefore no longer be available. available by prescription or over the counter.
INDICATIONS FOR HEALTHCARE OPERATORS
The Prac then gave indications for healthcare professionals, who must consider appropriate therapeutic alternatives and advise patients to stop taking medicines containing pholcodine. They will also be responsible for verifying whether patients who have to undergo general anesthesia with NMBA have used pholcodine in the previous 12 months.
WHAT IS FOLCODINA
Pholcodine is an opioid drug that has been used as a cough suppressant since the 1950s. Until now it was prescribed in both children and adults for the treatment of non-productive (dry) cough and, in combination with other active substances, for the treatment of cold and flu symptoms.
HOW IT WORKS
As Aifa explains , pholcodine works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
IN WHICH DRUGS IT IS PRESENT
Pholcodine, the agency says, is marketed under various names including Dimetane, Biocalyptol and Broncalene.
It can also be present in combination with other substances and is available in medicines in the form of syrups, oral solutions and capsules under various trade names and as generic drugs.
IN WHICH EU COUNTRIES WAS FOLCODINA AUTHORIZED?
However, in Italy, even before the Prac provision, pholcodine-based medicines were not authorized.
Within the EU, however, they are currently authorized in Belgium, Croatia, France, Ireland, Lithuania, Luxembourg and Slovenia, with a prescription or as over-the-counter medicines.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/quali-farmaci-per-tosse-e-raffreddore-non-potranno-piu-essere-venduti-secondo-ema/ on Mon, 05 Dec 2022 08:51:19 +0000.