The Nolotil soap opera continues. Although it is likely to meet its end with the European ban on metamizole. The reason is a new review, at the European level, on the risks associated with its use at the request of the Finnish authorities.
Metamizole in the spotlight (again). European Medicines Agency (EMA) Recently announced Metamizole, an analgesic and antipyretic that serves as the active compound in drugs such as Nolotil, is a new assessment of the risks associated with the use of metamizole. The person in charge of this review will be EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
Behind the decision is Finland, or rather the Finnish Medicines Agency, FIMIA. As the agency in charge of evaluating the safety of drugs distributed in the country, Fimea has warned that measures taken to limit the risks associated with these drugs may not be sufficient.
It did so following a request from the manufacturer, EMAO noted. In his statement.
Risk reduction. Despite tightening these controls, EMA explains, Finnish authorities continue to report cases of agranulocytosis associated with drug intake. In recent years, the position of health organizations regarding metamizole is one of risk reduction: we know that this drug has some associated dangers, but since it also has benefits, adequate follow-up of treatment will be sufficient to avoid the onset of the disease. .
An example of this strategy is the Spanish Agency for Medicines and Health Products (AEMPS). Unlike countries such as Ireland or France, this drug can be found in pharmacies in Spain, although there are some restrictions. In order to be able to conduct proper monitoring, the drug is dispensed by prescription and is not prescribed, for example, to tourists.
Agranulocytosis. The reason for all these precautions is not new, it is the risk of the appearance of agranulocytosis. agranulocytosis either, The same explains AEMPSA sharp decrease in neutrophils (Granulocytes), a type of white blood cell.
These cells play an important role in our immune system, so their loss can leave us vulnerable to various infections. In severe cases it has caused death in numerous patients.
rare The incidence is very low. According to the preliminary results of the latest research conducted by AEMPS, we would be talking about 1 to 10 cases per million users. These results, however, take as reference “the representative patient population of actual clinical practice in Spain.”
Because genetics is a risk factor for this adverse effect, these results may vary in other countries. In countries like the United Kingdom, for example the risk will be higher
Limited use, but not much. Nolotil is limited in Spain as we have already mentioned. Despite this drug usually increases list top seller In Spanish pharmacy.
Today 19 EU member states market medicines with metamizole, each with its own restrictions, they are (besides Spain): Germany, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Slovakia, Slovenia, Hungary, Italy, Latvia, Lithuania, Luxembourg, The Netherlands, Poland, Portugal and Romania.
Is the end of the unfinished story approaching? Metamizole Soap operas re-emerge from time to time (and the summer season is particularly favorable due to tourism). This process could end the bickering in Europe.
The PRAC review will still have to go through the European Coordination Group (CMDh), where AEMPS will be represented, and by the European Commission, which will ultimately and bindingly rule on what happens to the drug. At the European level.
In BDtechsupport | Nolotil is in the spotlight for “killing” Britons in Spain We really know this
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