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Álvaro Soto
Madrid
Monday, 9 September 2024, 19:39
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The European Medicines Agency (EMA) has endorsed the use of metamizole, a drug prescribed for severe and moderate pain and marketed in Spain under the brand name Nolotil (Boehringer Ingelheim).
It concludes that its benefits "outweigh its risks" after Finland called for a safety review linking it to agranulocytosis, a sudden, sharp drop in granulocytes (a type of white blood cell) that can lead to serious or even fatal infections. The European agency believes there is no reason to withdraw it from the market in the countries where it is sold, but at the same time, it has updated its recommendations and called for strengthened measures to facilitate early identification of symptoms and diagnosis of agranulocytosis.
What is Nolotil?
Metamizole, which was first sold in Germany in 1922, is an analgesic (painkiller) and antipyretic (against fever). It has been prescribed by doctors for more than 50 years in Spain under different trade names (the current one, Nolotil), according to the EMA. It is the most sold drug in Spain, with more than 24 million units per year. It is indicated as an analgesic for moderate or severe acute pain, and as an antipyretic when other alternatives are not effective.
Why did the EMA decide to investigate the safety of metamizole?
The EMA decided to investigate the origin of agranulocytosis, a known "serious" side effect of metamizole-containing medicines that can occur at any time during or shortly after stopping treatment and in people who have previously used metamizole without problems. Agranulocytosis is not related to the dose of metamizole used and existing measures to minimise this risk vary from country to country.
Is Nolotil safe?
Agranulocytosis, although very rare, is a serious adverse reaction that can be fatal because it promotes infections. The EMA endorses the use of the drug in the countries where it is sold and considers that its benefits outweigh its risks, but at the same time, it believes it is advisable to update the warnings on this product to increase awareness of its side effects and facilitate its early detection and diagnosis.
As such the EMA recommends that healthcare professionals warn their patients to stop taking medicines containing metamizole if they develop symptoms of agranulocytosis (fever, chills, sore throat and painful ulcers on internal, moist body surfaces - the mucous membranes - especially in the mouth, nose and throat or in the genital or anal regions).
Is there any population at higher risk of agranulocytosis?
The EMA report leaves the door open for future research to rule out or confirm an increased risk in populations with specific ethnic or genetic characteristics. So far, several studies have suggested that agranulocytosis is much more prevalent in Anglo-Saxon patients than in other groups, which is why metamizole is banned in Britain, the US, India and Australia, among other countries.
What is happening in Spain?
In Spain, where 24 million units are sold each year, the use of Nolotil has reached the courts. In April, the Public Prosecutor's Office of the National High Court asked to know the possible health risks of this drug and its adverse effects following a complaint filed by the Asociación Defensor del Paciente (patient defence agency). Before that, in February, Spain's national court announced that it was studying the complaint of another organisation, the Association of People Affected by Drugs (ADAF), against the ministry of health and the Spanish medicines and health products agency (AEMPS), considering that it did not protect the population against the potentially fatal side effects of this compound.
According to ADAF, there were 350 suspected cases of agranulocytosis between 1996 and 2023 in Spain, including 170 Britons who have suffered sepsis, organ failure and amputations. In addition, ADAF is examining 40 deaths that the drug may have caused or at least contributed to.
The large presence of tourists from northern European countries in regions such as Andalucía and Valencian has put the spotlight on Nolotil. In 2009, the Costa del Sol Hospital in Marbella published research concluding that agranulocytosis due to metamizole is an adverse effect that occurs more frequently in the British population. On 30 October 2018, the Aemps asked healthcare professionals "not to use metamizole in patients where monitoring is not possible (e.g. in a floating population)".
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