MADRID – The Association of Those Affected by Drugs (ADAF) has filed a lawsuit against the Spanish Ministry of Health and the Spanish Agency for Medicines over the side effects of Nolotil (Metamizole).
This analgesic, widely used in Spain, has been linked to serious health risks. These include allergic reactions, sudden immune system collapse, and multiple organ failure. According to factchack website Newtral ADAF reports at least 350 cases of such side effects. Moreover, a significant number of these cases involve British citizens.
Growing concerns and demands for a ban
ADAF President Cristina García del Campo highlights an increase in reported cases following the lawsuit. The association, though Spanish, is pushing for a nationwide ban on metamizol due to its adverse effects on both local and foreign populations.
Agranulocytosis: A rare but serious risk
Listed as “very rare” in Nolotil’s leaflet, agranulocytosis can lead to severe infections and death. Pharmaceutical company Boehringer Ingelheim acknowledges this risk. Futhermore, asserting that it has been known for decades and is detailed in the drug’s safety profile.
Nolotil’s dilemma with British patients
The Spanish Society of Hospital Pharmacy (SEFH) notes metamizol’s effectiveness, especially for colic pain. Despite its widespread use in Spain, countries like the UK have banned it due to the risk of adverse reactions. This poses a challenge for public health services treating foreign patients. In 2018, the Aemps advised against prescribing metamizol to tourists due to the inability to conduct clinical follow-ups and observed a higher incidence of agranulocytosis in British patients.
Genetic factors in adverse reactions
Iván Espada from the General Council of Pharmaceutical Colleges (CGCF) explains that susceptibility to side effects can depend on genetic factors, including geographical origin. Both SEFH and CGCF agree that British citizens are more predisposed to adverse effects from metamizol. However, it remains unclear whether this is due to genetic reasons or lack of exposure, as the drug is banned in the UK.
Limited research but clear risks
Scientific literature on this subject is scarce, but a 2018 Aemps document and a European Medicines Agency report from the same year linked agranulocytosis risk to genetic characteristics of populations. A 2009 study from the Costa del Sol Hospital also found higher risk among British patients, suggesting they should avoid Nolotil.
Also read: Painkiller banned in UK also linked to deaths in Spain
