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Spain's High Court has launched an investigation into Nolotil - which has been banned in several other key countries - following dozens of deaths allegedly linked to the popular painkiller.
It comes after a complaint filed by the Asociación Defensor del Paciente patient defence association which called for the commonly prescribed drug to be banned due to its claimed adverse health effects.
The public prosecutor's office will now request the Spanish Agency for Medicines and Health Products (AEMPS) to submit a report on the sale of Nolotil. Details included in the report will relate to the drug's manufacturing, marketing and distribution points in Spain, authorisations granted, adverse reaction reports, as well information on why the drug has been banned in other countries and not in Spain.
High Court chief prosecutor Jesús Santos said the aim will be "to hear all those administrative actions that fall within the competence of, among others, the Spanish Agency of Medicines and Health Products in relation to the medicine Nolotil".
Last February, the Contentious-Administrative Court reported it was looking into a complaint filed by the Association of People Affected by Drugs (ADAF) against the ministry of health and AEMPS, accusing them of negligence due to the adverse effects Nolotil may cause in many people.
The case stemmed from a lawsuit filed by ADAF in November 2023 and a complaint to the state Attorney General's office in January this year, accusing those responsible for monitoring this drug of gross negligence that has caused "harm and even death" to patients.
ADAF's complaint questioned the safety of drugs that use metamizole, such as Nolotil, which is "one of the most sold drugs in Spain" as it is used as a painkiller. To date, metamizole-containing products have been banned in the US, UK, Ireland, Sweden, Japan and Australia.
In the 2023 lawsuit, they also pointed out the drug Nolotil "is being wrongly prescribed to British people visiting Spain, or residing in Spain, i.e. the floating population, because this drug, the most widely sold in Spain, is very dangerous for this type of population".
In November 2018, the medicines agency of the ministry of health recommended not to give medicines to tourists containing metamizole, such as Nolotil or Buscapina Compositum, and in the case of those who could be monitored, to provide it only in minimal doses.
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