As of this weekend, it is no longer possible to obtain Pneumorel in pharmacies, even with a proper prescription. The National Medicines Safety Agency (ANSM) has just suspended the Marketing Authorization (AMM) for this medicine against coughing because its active principle, fenspiride, is likely to cause heart rhythm disturbances.
An unfavorable benefit / risk ratio
In France, this expectorant drug is prescribed but is not reimbursed. He is available in syrup form (Pneumorel 0.2%, syrup) or tablet (Pneumorel 80 mg, coated tablet).
Certain cases of cardiac arrhythmias under fenspiride had led the ANSM and the European Medicines Agency (EMA) to request the establishment of additional studies. Given the results of these new studies and the non-essential nature of these drugs, the ANSM has therefore decided to recall the batches of drugs because of a benefit / risk ratio that has become unfavorable.
Immediate discontinuation of treatment
“From now on, as a precautionary measure, all patients who hold boxes or bottles of Pneumorel are asked to no longer use these drugs and to return them to the pharmacy” underlines the ANSM which however wishes to reassure patients who have used this drug by emphasizing “that there is no longer any risk as soon as the treatment is stopped”.
She advises patients to contact their pharmacist or doctor if necessary since others cough medicine are available in pharmacies, on pharmaceutical advice or on medical prescription.
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