Painkiller linked to deaths of British expats to finally be investigated

MADRID – The European drugs regulator has launched an investigation into a common painkiller linked to a series of illnesses and deaths of Britons in Spain.

The European Medicines Agency (EMA) said it was reviewing the painkiller metamizole, which has been linked to agranulocytosis, a potentially fatal condition in which a patient’s white blood cells are severely depleted. White blood cells are part of the body’s immune system which help to fight disease.

The Spain-based Association of Drug Affected Patients (ADAF), which has campaigned to bring in more controls on the drug in the country, claims that it has caused reactions including sepsis, amputation and deaths.

The drug is banned in a number of countries including the UK but is easily available in Spain under the name Nolotil and is on sale from pharmacists for about €2.

The ADAF has identified about 400 cases of suspected agranulocytosis between 1996 and 2023, involving 170 Britons. Most were living in Spain and a smaller number were on holiday.

Ron Earwaker, 72, who lives in Murcia in southeastern Spain, said his wife Susan died in 2015 after she was given Nolotil as a painkiller after breaking her right leg when she fell from a horse. She was 62 and healthy but died 18 days after the accident.

“A couple of days after the accident she developed a heavy cold. It got worse and worse. She was taken to a hospital where they said she had no white blood cells. They said this is very dangerous,” Mr Earwaker, a retired businessman from London who has lived in Murcia for the past 20 years.

“I believe she was put on a drip with metamizole. They put her in an induced coma. They said all her organs were shutting down.. Later the doctor said she did not make it. The cause of death was agranulocytosis caused by a reaction to metamizole.”

He added: “I find it quite amazing that virtually the rest of the world has banned this drug because of the side-effects.”

He added: “It seems to be mainly northern Europeans who are getting this reaction, but I am not saying that Spaniards don’t suffer from this.”

Two studies by Spanish doctors suggest there is a higher risk of British people suffering potentially fatal side effects from the painkiller.

The ADAF is taking legal action against Spain’s Ministry of Health and its Medicines and Health Products Agency (AEMPS), claiming the drug has been offered without proper controls.

Cristina García del Campo, founder of the ADAF who works as a medical translator, said she was pleased the EMA was investigating. “I am very happy that they are doing this. It is about time. I wrote to them seven years ago and they took no notice. I have written to them several times. Had they acted before a lot of unnecessary deaths might have been prevented,” she told i.

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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 review was requested by the Finnish medicines agency after recent cases of agranulocytosis. A company marketing metamizole in Finland had requested its market authorisation to be withdrawn for safety reasons, the EMA said.

In 2018, the AEMPS brought out new guidelines for metamizole which recommended tourists should avoid using it and that patients should be advised of the risk of agranulocytosis.

Nolotil’s maker, Boehringer Ingelheim, said: “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 authorizations. Boehringer Ingelheim will closely collaborate with health authorities during this review.”

On a previous occasion it said: “There have been two recent reviews of metamizole and its association with cases of agranulocytosis by the medicine’s regulator in Spain. In 2023, the AEMPS concluded that, based on a review on all available information, there were no changes to the established risk profile for agranulocytosis associated with metamizole.

“Although a greater susceptibility for agranulocytosis in people of northern European descent has been discussed for several years and certain generic factors have been examined, a higher risk in populations with specific ethnic characteristics can neither be confirmed nor ruled out.”