Yzabelle Bostyn
SPAIN’S high court will investigate Nolotil following dozens of deaths linked to the country’s most popular painkiller.
It comes after a judge rejected an appeal by the state appointed lawyer, representing the Spanish Medicine Agency (AEMPs).
The lawyer said the decision to summon AEMPs and Nolotil producer Boehringer Ingelheim before Spain’s high court, was ‘unnecessary’.
Anti-Nolotil campaigner Cristina del Campo said the attempt by state lawyers to dismiss the case showed bias.
She said: “They are defending a dark, manipulative system instead of protecting their citizens and upholding justice.”
Now, both parties will have to present evidence to the high court to evaluate if Nolotil poses ‘a risk of adverse effects for health’.
Mechanisms for ‘authorising’ drugs and ‘communicating adverse effects’ will also be investigated.
It comes after the Patient’s Defence Association issued a report to the high court in February this year.
The email denounced the negative side effects of Nolotil for which ‘it has been banned in many countries.’
The report follows a lawsuit filed by the Association of Drug Affected Patients, a patient advocate group, against the Spanish Ministry of Health and AEMPS for ‘failing to properly regulate Nolotil’.
They believe the painkiller has led to over 40 deaths of British and Irish people in Spain.
As well as the lawsuit, the ADAF filed a criminal complaint with the Spanish public prosecution office against AEMPs and the Spanish Ministry of Health.
Initial proceedings into this case will also begin, to investigate if Nolotil truly does ‘provoke harm’ and to ‘find those responsible’.
Campaigner Cristina del Campo said: “This is big news. Nolotil is the most sold medicine in the country so it’s a big step in the right direction.”
Both cases will be heard in Madrid but it is expected that any decisions made will affect the whole country.
The last update of the medical advice for Nolotil was in 2018, when AEMPs issued an informative note stating the medicine should not be given to patients without a thorough background check and the possibility of follow ups.
It followed an exhaustive campaign by the ADAF and The Olive Press to introduce more restrictions on the drug, which has extreme side effects for northern europeans.
Due to genetic differences, the drug does not typically have side effects for Spanish people.
However for northern europeans it reduces white blood cell count to dangerously low levels (agranulocytosis) provoking sepsis, organ failure and in some cases, death.
Despite the 2018 note, the ADAF and the Olive Press continued to receive reports of cases and in 2023, the death of 42-year-old British expat, Mark Brooks, prompted AEMPs to once again review the medication.
The new advice, issued in December 2023, maintained existing regulations and stated that Nolotil was safe to use.
The drug, whose main ingredient is metamizole, is currently banned in many countries including Australia, the UK, France, Norway and Denmark.
Despite this, Spanish medical authorities have claimed there is no significant scientific evidence to show the drug is dangerous.
They state the incidence of agranulocytosis is between 1-10 per million users.
However, other studies have found higher levels of agranulocytosis in foreign patients.
In 2009, Hospital Costa del Sol in Marbella observed this side effect was three times more common in foreign patients.
Experts consulted by The Olive Press said: “The problem with analgesics (painkillers) is that there is a gap between the likes of ibuprofen and paracetamol and opioids. You need something in the middle and it seems that Spanish doctors feel metamizole is in that middle ground.”
Regulators are therefore reluctant to pull the drug from the market, ignoring the ‘duty of care’ to their large northern european expat population.
Although she didn’t directly comment on the case, The Minister of Health, Monica Garcia, said: “Like all medications, Nolotil has side effects. In some cases, supervision and checkups are necessary.”
In an interview on CatalunyaRadio, she added: “Medications are always evaluated and all have risk-benefits that we must evaluate.”
