EMA calls to withdraw cough suppressant over allergic reaction risk

Regulatory NewsRegulatory News | 05 December 2022 |  By 

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The European Medicines Agency (EMA) has recommended that pholcodine-containing drugs be pulled from the European market after its experts agreed there was a significant risk of allergic reaction to neuromuscular blocking agents (NMBA). The recommendation has been sent to the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) for a final decision.
On 2 December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) announced that pholcodine-containing drugs should be withdrawn after analysis of a postmarket study entitled Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure (ALPHO). The study found the drugs, which are used to treat dry cough, are linked to a risk of anaphylactic reactions to NMBA’s that are used in general anesthesia.
Pholcodine is an opioid-based medicine used to treat dry cough, as well as cold and flu symptoms. The drug suppresses nerve signals from the brain which depresses cough reflexes and the muscles that trigger coughing.
“As it was not possible to identify effective measures to minimize this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh its risks, pholcodine-containing medicines are being withdrawn from the EU market and will therefore no longer be available by prescription or over-the-counter,” said the EMA.
“Healthcare professionals should consider appropriate treatment alternatives and advise patients to stop taking pholcodine-containing medicines,” the agency added. “Healthcare professionals should also check whether patients scheduled to undergo general anesthesia with NMBAs have used pholcodine in the previous 12 months, and remain aware of the risk of anaphylactic reactions in these patients.”
PRAC has sent their recommendation to CMDh for a final decision. In the meantime, regulators are recommending that patients talk to their physician or pharmacist for alternatives to the drug. The agency also recommends that those who have taken pholcodine-containing medicines in the past year talk to healthcare providers if they need general anesthesia with NMBAs.
CMDh is responsible for harmonizing safety standards for drugs used in the EU member states as well as Iceland, Liechtenstein and Norway, and is tasked with making a decision on whether to adopt the EMA’s recommendations across regulatory regimes.
Pholcodine entered the market in the 1950s as a cough suppressant and is still used in the EU in member states such as Belgium, Croatia, France, Ireland, Lithuania, Luxembourg and Slovenia, either over-the-counter or with a prescription. EMA notes that the medicine is often available in Europe in combination with other drugs in syrups, oral solutions and capsules under various trade names and as generics. It is marketed under various names, including Dimetane, Biocalyptol and Broncalene.
After initial signals raised concerns about allergic reactions from pholcodine, France asked the EMA to conduct a postmarket study through its referral procedures in September.


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