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The Committee for Safety and Pharmacovigilance of the European Medicines Agency (EMA), called Prachas started a review of the medicines they contain pseudoephedrinefollowing a non-negligible – albeit very small – number of cases of encephalopathies and other conditions affecting blood vessels in the brain. An active ingredient mainly used as nasal decongestant in cases of cold, flu, and rhinosinusitis, as well as to treat various forms of allergies affecting the airways.
In the light of the new information available, the security profile of this class of medicinal products, based on epidemiological, clinical and pharmacovigilance data. It will then be up to the Prac to examine all the evidence collected and provide the right indications and recommendations to ensure a possible adaptation of the package leaflet and the directives on its use. Pseudoephedrine-containing drugs still remain today available and purchasableas at the moment the contours of the investigation are not such as to impose a review of the overall safety profile of the active ingredient.
An active ingredient to fight colds
There pseudoephedrine is a sympathomimetic amine which – acting as a mimic of the effects of stimulation of the sympathetic nervous system on various tissues – acts as stimulator of nerve endings, promoting the release of norepinephrine and the resulting narrowing (constriction) of blood vessels. This leads to a reduction in swelling and less mucus production in the nose, following the reduction in the amount of fluid released from the vessels.
Medicines containing pseudoephedrine are authorized in most member states of the European Union and in most countries they contain this substance in combination with other active ingredients, to obtain a contrast effect of the typical symptoms of the flu. Pseudoephedrine is an active ingredient found in many commonly used drugs such as Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume and Nurofen Cold and Flu. Fluimucil (in the version for flu and colds) and Aspirin (in the version for flu and stuffy nose) also contain it. It can also be found in many over-the-counter drugsi.e. purchasable without a prescription, for the treatment of symptoms such as colds, flu and allergic rhinitis.
Side effects already known
Medicines that contain pseudoephedrine, as is the case for most of those regularly on the market, can give rise to side effects minor or modest. Among the most frequent in this case are gastrointestinal disorders such as nausea and vomiting, dry mouth, headache, dizziness and alteration of cardiovascular parameters (heart rate, blood pressure, palpitations and tremor). There are also other, less frequent symptoms, which are reported in the package leaflet. Medicinal products containing pseudoephedrine are also known to pose a risk for ischemic cardiovascular and cerebrovascular events, including serious adverse events such as stroke And heart attack.
For this reason, people suffering from hypertension, heart disease, diabetes, asthma or other must pay attention to the intake of this active principle, contacting their doctor beforehand. Among others it is known that they are contraindicated for some specific categories of people, such as pregnant women or in breastfeeding stage breast.
What do we know about the investigation launched
The review of medicines containing pseudoephedrine was initiated at the request of theFrench Medicines Agency (Ansm) after they have been registered 10 cases side effects affecting the cerebral blood vessels. Specifically, the possible risk of developing a posterior reversible encephalopathy syndrome and a reversible cerebral vasoconstriction syndrome are being investigated. These are conditions that affect the blood vessels in the brain and can lead to reduced blood flow (ischemia) to the brain, causing in some cases even serious and life-threatening complications for the patient.
It is good to specify that it is not a procedure initiated to remove the drug from the market, both for the limited number of adverse cases that have emerged so far and because pseudoephedrine cannot be replaced for the treatment of some specific pathologies. Our Italian drug agency (Aifa) immediately reassured, through a press releasewhich is not a urgent issue. In fact, these are – explains the Agency – very rare cases that cannot significantly alter the benefit/risk ratio of these medicines, not legitimizing immediate restrictive actions on the use of this class of medicines. Aifa will provide constant updates on the procedure in progress, to offer the necessary support to minimize all the risks that could be encountered.
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