Not just Actifed. Which cold medicines is the EMA reviewing for ischemia risk?
Following a number of cases of pathologies responsible for a reduced blood supply to the brain, which can lead to ischemia, some cold, flu or allergy medications containing pseudoephedrine are being investigated. Here's what they are, what Ema, Aifa and the comments of the experts said
The European Medicines Agency (EMA) has launched an investigation into the safety of medicines containing pseudoephedrine, an active ingredient administered to treat colds and flu, following a small number of cases in which – in conjunction with their intake – some pathologies have been reported that can cause a reduced blood flow to the brain, which can result in ischemia.
The investigation started at the request of the French National Agency for the Safety of Medicines and Health Products (ANSM).
WHAT THE EMA SAID
EMA's safety committee (PRAC) said it had launched a review of pseudoephedrine-containing medicines following concerns over the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), associated with its hiring.
Both conditions can lead to reduced blood supply to the brain (ischemia) and, in some cases, serious and life-threatening complications. The most common symptoms associated with Pres and RCVs, explains the EMA, include headache, nausea and convulsions.
WHAT THE EMA WILL DO
After examining the available evidence, the Committee will have to decide whether the marketing authorizations of medicines containing pseudoephedrine should be maintained, modified, suspended or withdrawn across the EU.
WHAT IS PSEUDOEPHEDRINE
Pseudoephedrine, explains the Agency, is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion due to colds, flu or allergies.
It is an active ingredient that works by stimulating nerve endings to release norepinephrine, which causes blood vessels to narrow. This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose.
THE WARNINGS (ALREADY) PRESENT
Medicines containing pseudoephedrine, says the EMA, have a known risk of cardiovascular and cerebrovascular ischemic events (side effects involving heart and brain ischemia), including stroke and heart attack . To reduce these risks, restrictions and warnings are already included in the product information of the medicines.
WHAT DRUGS IS IT ON
Pseudoephedrine-containing medicines are authorized in several EU states alone or in combination with medicines to treat cold and flu symptoms, such as headache, fever and pain, or allergic rhinitis in people with nasal congestion.
Among the names of drugs made by the EMA are Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume and Nurofen Cold and Flu.
WHAT AIFA SAID
In relation to the European review procedure for pseudoephedrine-based medicines, launched by the EMA, Aifa specified that "currently the benefit/risk ratio of these medicines remains positive and there are no urgent safety issues that imply immediate restrictive actions on the use of this class of medicines”.
EXPERT OPINION
“We try not to alarm. These are few cases and the fact of starting a review procedure does not mean that those who have taken” these drugs “should be worried”, reassures Matteo Bassetti, head of infectious diseases at the San Martino hospital in Genoa. “Drugs all have more or less important side effects and should only be taken when needed”.
Guido Rasi, former director of EMA and now consultant to Health Minister Orazio Schillaci on medicines, also agrees with Bassetti, who said that "a routine activity is taking place". “However, great attention is needed – he specified -. Even if they are over the counter, they have side effects. They must therefore be used following the instructions on the leaflets and perhaps every time they are purchased it is better to check with your doctor, for example to be told how many can be used".
Francesco Scaglione, professor of Pharmacology at the University of Milan and clinical pharmacologist at the Niguarda Hospital, in addition to recalling that the risks associated with pseudoephedrine are already known, recommends particular attention to people with heart disease or hypertension and believes that these products "should be sold only on prescription, precisely because of the risks they entail in the event of prolonged or frequent use".
Also according to Silvio Garattini , pharmacologist and founder of Mario Negri, "for non-prescription drugs there should be more controls than the others and there should be an Authority for the control of advertising messages, which only present the benefits, without indicating the contraindications . There should be a specific body for the timely control of what is written and said on TV or in other media about health products, including supplements".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/quali-farmaci-per-il-raffreddore-sta-revisionando-ema-per-rischio-ischemia/ on Mon, 13 Feb 2023 09:36:19 +0000.