An investigation has been launched by the European drugs regulator into a popular painkiller linked to a series of illnesses and deaths.
The European Medicines Agency (EMA), one of the biggest EU regulators, confirmed on Friday it was reviewing the painkiller metamizole, which can lead to agranulocytosis, a potentially fatal condition in which a patient’s white blood cells are severely depleted.
It was revealed by the Observer last November that a patients group in Spain had launched a legal action against their government over claims it had failed to safeguard people against the drug’s side-effects.
The drug, marketed in Spain under Nolotil brand, is already banned in several countries, including the UK. The EMA said there were “concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough”.
The EMA’s review was requested by the Finnish medicines agency after recent cases of agranulocytosis. A company marketing metamizole in Finland had requested its market authorisation be withdrawn for safety reasons, the EMA said.
The regulator said: “EMA’s safety committee will now review the risk of agranulocytosis for all metamizole-containing medicines authorised in the EU.
“The committee will assess the impact of agranulocytosis on the benefit-risk balance of the medicines and issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked across the EU.”
The agency said product information on metamizole lists agranulocytosis as either a rare side effect (occurring in up to 1 in 1,000 people) or a very rare side-effect (up to 1 in 10,000). Measures to minimise this risk varied across countries, it said.
The Association of Drug Affected Patients (ADAF) in Spain says adverse reactions to the drug have led to sepsis, amputations and deaths. It has identified about 350 suspected cases of agranulocytosis between 1996 and 2023, involving 170 Britons who live or were on holiday in Spain.
The association’s legal action against Spain’s ministry of health and its medicines and health products agency alleges the drug has been offered without proper controls. It is meant to be available only on prescription, but the Observer was able to buy the drug over the counter without a prescription last November.
Cristina García del Campo, founder of ADAF, welcomed the investigation. She said: “This is great news. People are starting to notice these cases now. They have been under-reported for years.”
In October 2018, the AEMPS, brought out new guidelines for metamizole. It recommended its use by tourists be avoided and that patients should be advised of symptoms of agranulocytosis.
Nolotil’s maker, Boehringer Ingelheim, has said adverse side effects are listed on the drug information sheet and the current prescribing information “adequately addresses current knowledge about risks”.
The firm, which markets medicines containing metamizole in Spain and Portugal in the EU as well as a few countries in Latin America, said: “In Spain, Boehringer Ingelheim is one of 16 companies that supply metamizole. Agranulocytosis [is] a rare side effect and is well-described in the product information. We collect and analyse all available information and reports on our medicines and pass them on without delay to the relevant authorities. We welcome the EMA review of medicines containing metamizole, as it will assess the impact of agranulocytosis on the risk-benefit balance of the medicines and issue a recommendation on their marketing authorisations. Boehringer Ingelheim will closely collaborate with health authorities during this review.”
• This article was amended on 18 June 2024 to include a comment from Boehringer Ingelheim.
