Recognized as dangerous for 20 years, why is this drug still not banned by the European Medicines Agency?
For 20 years, the journal Prescriber, which annually lists ineffective and dangerous drugs, has pointed to the unfavorable benefit-risk balance of pseudoephedrine, an ingredient still used in medications prescribed for colds and nasal congestion. Despite everything, the European Medicines Agency has renewed its faith.
The effects of pseudoephedrine, an ingredient used in many winter medicines such as Dolirhum or Humex, have long been known. Every year, we hear doctors and pharmacists warning patients about the dangers of these drugs on the heart. Despite this, they are not prohibited.
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At the end of last year, the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) recognized the existence of two serious cardiovascular and neurovascular effects of this drug: posterior reversible encephalopathy syndrome and posterior reversible encephalopathy syndrome. ). This is in addition to the decades-known risks of myocardial infarction and stroke.
A simple mention in the list of side effects
Being minor, these new risks have been identified as “potentially fatal”. However, despite all these worrying signs, the PRAC proposed reporting the new risks in a patient-only leaflet and asked carers to try to limit harm by informing patients and asking questions. The recommendation, which the European Medicines Agency has chosen to follow, corresponds to the concern of the journal Prescriber, which sees it as a real “missed opportunity” to save (European patients).
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Indeed, the simple mention of risks in a list of side effects has a very limited impact on patients’ habits. “And caregivers have better things to do than spend time counseling patients against a drug that should be withdrawn from the market,” lament prescriber experts.
