The Prac, the EMA safety committee that we have known well in recent years, has started a review of the marketing authorizations granted to medicines containing pseudoephedrine. Among these there are also well-known trade names used to treat the nasal congestionthe typical “stuffy nose” from a cold, flu or allergy: Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume And Nurofen Flu and cold among others.
The reason? The committee wants to analyze the data from the pharmacovigilance systems of European countries and from updates of the scientific literature with respect to the possible risk that would link pseudoephedrine – which is taken alone or in combination with other drugs and active ingredients such as antihistamines, guaifenesin, dextromethorphan, paracetamol or other NSAIDs and orally – to two syndromes. The one from posterior reversible encephalopathy (PRES) and the one from reversible cerebral vasoconstriction (RCVS), conditions that affect blood vessels in the brain. That is, they can cause a reduced blood flow to the brain, an ischemic situation which in some cases could lead to serious complications, even fatal. Symptoms of these syndromes include headaches, seizures, and nausea. A small number of cases it has been reported by continental pharmacovigilance and scientific studies and the EMA therefore wants to establish whether to confirm the authorizations, modify them, suspend them or even withdraw them.
For these medicinal products the risks of cardiovascular and cerebrovascular ischemic events they are already knownand indeed the restrictions and warnings to reduce these possible risks are already reported in product information, in short, in leaflets. However, considering the seriousness of the two syndromes and crossing it with the situations – very broad – for which those drugs are indicated or recommended, a new study is necessary. Pseudoephedrine is a sympathomimetic drug whose salts, used precisely in these drugs, stimulate the nerve endings to release norepinephrine, a hormone and neurotransmitter that causes blood vessels to constrict. This mechanism reduces the amount of fluid released from the vessels and therefore in cascade allows the user to reduce nasal swelling and limit the production of mucus in the nose. Naturally found in products that treat cold and flu symptoms such as fever, headache or pain, and allergic rhinitis.
The Ansm, the French medicines agency, asked the EMA to initiate the review, on the basis of a dozen serious cases on people with certain individual risk factors. Once the Prac’s recommendations have been formulated, they will be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions relating to medicinal products for human use, which will adopt an opinion. At the end of the process, the European Commission, on the basis of the opinion, could take a legally binding decision with respect to some of those drugs or even all those that contain that active ingredient.
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Source: Vanity Fair
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