Europe’s drug regulator has launched an investigation into a popular painkiller linked to a series of illnesses and deaths.
The European Medicines Agency (EMA), one of the EU’s top regulators, confirmed on Friday that it is reviewing the painkiller metamizole, which can lead to agranulocytosis, a potentially fatal condition in which a patient’s white blood cells are severely depleted.
That was revealed by the Observer last November that a patient group in Spain had launched legal action against their government over claims it had failed to protect people from the drug’s side effects.
The drug, marketed in Spain under the brand Nolotil, has already been banned in several countries, including the United Kingdom. The EMA said there are “concerns that the measures taken to minimize the known risk of agranulocytosis may not be effective enough”.
The EMAs judgement was requested by the Finnish Medicines Agency following recent cases of agranulocytosis. A company marketing metamizole in Finland had requested its market authorization be withdrawn on safety grounds, the EMA said.
The regulator said: “The EMA safety committee will now assess the risk of agranulocytosis for all metamizole-containing medicines authorized in the EU.
“The committee will assess the impact of agranulocytosis on the benefit-risk balance of the medicines and make a recommendation on whether their marketing authorizations should be maintained, varied, suspended or withdrawn across the EU.”
The agency said the product information for metamizole lists agranulocytosis as a rare side effect (affecting up to 1 in 1,000 people) or a very rare side effect (up to 1 in 10,000). Measures to minimize this risk varied from country to country, the report said.
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The Association of Drug Affected Patients (ADAF) in Spain says the drug’s side effects have led to sepsis, amputations and deaths. It has identified around 350 suspected cases of agranulocytosis between 1996 and 2023, involving 170 Britons living or on holiday in Spain.
The association’s legal action against the Spanish Ministry of Health and the Medicines and Health Products Agency alleges that the drug was presented without proper controls. It is intended to be available by prescription only, but the Observer was able to buy the drug without a prescription last November.
Cristina García del Campo, founder of ADAF, welcomed the research. She said: “This is great news. People are now starting to notice these cases. There has been under-reporting for years.”
In October 2018, the AEMPS released new guidelines for metamizole. It recommended avoiding its use by tourists and informing patients of symptoms of agranulocytosis.
Nolotil’s maker, Boehringer Ingelheim, has said that adverse side effects are listed on the drug’s information sheet and that current prescribing information “adequately addresses current knowledge of risks.” The company has been contacted for comment on the EMA’s assessment.