2023-12-01 13:00:00
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He metamizolmarketed as Nolotil, has established itself as one of the most used medications in Spain to combat pain, fever and inflammation. However, its history is tainted by a shadow of controversy that has recently resurfaced, catapulting the issue to the front page of current news.
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The recent mobilization of a British patients association, the ADAFwhich has taken legal action against the Government of Spain, has fueled the debate about the safety of this drug. The concern centers on a key question: does metamizole represent a significant health risk?
Origins of the controversy
The ADAF, representing affected British citizens, maintains that Nolotil has caused serious adverse effects in British and Irish tourists who were prescribed this drug during their stay in Spain. The association cites 170 suspected cases of serious side effects in the last 27 yearsrelated to the consumption of Nolotil.
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Nolotil commercial packaging.
This problem is not new. Already in 2018, the Spanish Medicines Agency issued a cautionary note addressed to health professionals, recommending avoiding the prescription of metamizole to “floating population”, that is, to tourists or temporary visitors. This warning was based on reports of agranulocytosis, especially in British patients, a serious side effect although classified as “very rare” in the drug’s package insert.
The agranulocitosis, a critical drop in white blood cell levels, severely compromises the immune system, leaving the body vulnerable to infections that can be fatal. Although the risk of developing this condition is low, it appears to be more prevalent among citizens of northern Europe, suggesting a possible genetic predisposition that would increase their vulnerability to this side effect of metamizole.
The position of the Spanish health authorities
Despite these risks, the Spanish Agency for Medicines and Health Products (AEMPS) maintains that the benefits of Nolotil outweigh its risks, as long as it is administered under medical prescription and supervision. This judgment is based on a continuous evaluation of the risk-benefit ratio of the medicine, a common practice in pharmaceutical regulation.
Nolotil is one of the best-selling pain relievers in Spain, with more than 22 million boxes dispensed annually in pharmacies. Its popularity contrasts with the restriction or prohibition of its sale in countries such as the United Kingdom, Ireland, the United States, India and Australia. This international discrepancy reflects differences in drug regulation policies and in the perception of the risk associated with metamizole.
Conclusion
The controversy surrounding metamizole raises fundamental questions about how risk is assessed and communicated in medication use. While health authorities and healthcare professionals continue to monitor and adjust their recommendations, patients should be informed and consult their primary care physician before taking any medication, including Nolotil.
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