Laurence Dollimore
THE European Medicines Agency (EMA) has ruled out banning or bringing in tougher restrictions on controversial painkiller Nolotil – for now.
The EMA has been studying metamizole, the main ingredient in Nolotil, over its potential to cause a severe or total loss of white blood cells in patients (agranulocytosis).
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It comes after hundreds of deaths of British expats and tourists – and other northern Europeans – have been linked to the drug.
The cases have been compiled by health campaigner Cristina del Campo, who has been fighting against the drug for years and who is now seeking compensation for family members of those who died after taking it.
The Olive Press has also launched multiple campaigns to raise awareness of Nolotil and to plead for tougher regulations.
Despite this, the Spanish Agency for Medicines and Health Products (AEMPS), says the EMA found the benefits of Nolotil ‘outweigh the risks’.
The EMA began a review of medicines containing metamizole in June 2024, at the behest of the Finnish Medicines Agency – after the country reported multiple cases of agranulocytosis.
Based on the evaluation of all available scientific evidence, the European Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA has concluded that the benefit of medicines containing metamizole outweighs the risks.
It said measures must be reinforced to facilitate the early identification of symptoms and diagnosis of agranulocytosis.
However, the information available to date does not allow them to rule out or confirm a higher risk in populations with specific ethnic or genetic characteristics.
British and other people of northern-European descent are believed to be more at risk from the drug due to their genetic make up.
The conclusions of the evaluation carried out by the PRAC must be ratified by the Coordination Group (CMDh) of the EMA, which includes all the European medicines agencies.
