‘They thought I had cancer’: painkiller banned in UK linked to Britons’ deaths in Spain

A patient group representing several British victims has taken legal action against the Spanish government over claims it has failed to protect people from the potentially fatal side effects of one of the country’s most popular painkillers, which has been implicated in a series of serious diseases and deaths.

The drug metamizole, commonly sold in Spain under the brand name Nolotil, has been banned in several countries, including Britain, the US, India and Australia. It can cause a condition known as agranulocytosis, which decreases the number of white blood cells, increasing the risk of a potentially fatal infection.

The Association of Drug Affected Patients (ADAF) says side effects from the drugs have led to sepsis, organ failure and amputations. It has identified around 350 suspected cases of agranulocytosis between 1996 and 2023, including those in 170 Britons living or holidaying in Spain.

The ADAF is investigating more than forty fatalities in which it believes that the drug led to or contributed to death. The patient group says case reports, including a 2009 study, suggest the British population may be more sensitive to the drug’s side effects, but this has not been confirmed by independent scientific research.

The group demands an investigation into the drug and new controls. She filed an appeal with the National Court of Madrid on November 14. Cristina García del Campo, founder of the organization, said: “This drug has destroyed people’s lives and must now be stopped. One lady took three tablets and had part of her feet amputated and a number of fingers. Even if it doesn’t kill you, once you have sepsis, your body is never the same again.”

Metamizole was first commercially produced in Germany in 1922 and was available worldwide until it was discovered that there was a risk of it causing agranulocytosis. It was withdrawn in around 30 countries, but is still available throughout the EU.

Studies have shown a dramatic variation in the estimated incidence of agranulocytosis in response to the drug, from about one in 2,000 to less than 1.1 per million users. a Report from the European Medicines Agency in December 2018 suggested that “the potential to induce agranulocytosis may be associated with the genetic characteristics of certain populations”.

García del Campo, a translator from Jávea in Alicante, started an investigation when one of her clients, an Irishman, became seriously ill, with infections ravaging his body. He was hospitalized in the city of Dénia and died on November 18, 2017 from sepsis and multi-organ failure.

She said: “I was the last person with him and held his hand. The whole time I was with him I kept asking, ‘Why is this happening? How can someone go from a good condition to a terrible infection?’”

She began piecing together disturbing recent reports she had heard locally about agranulocytosis and sepsis. One evening in December 2017, she spread out all the files and medical notes she had collected on six cases. Then it struck her: everyone involved had used metamizole.

One of the patients in García del Campo’s file, Paddy Clancy, 80, a British expat living in Jávea, said last week that he almost died after being given metamizole following shoulder surgery in September 2017. He became so ill that doctors putting him into a medically induced coma to give his body the best chance to fight the infection.

Clancy said: ‘My wife was told, ‘His kidneys are running out and his organs are shutting down.’ They thought I might not last the weekend.” The family was told that his body’s white blood cells, which normally fight infections, had been severely depleted.

Clancy came out of the coma after 39 days. He had lost 22kg and was unable to stand, but has gradually recovered. His data confirms the condition that almost killed him: “agranulocytosis associated with metamizole”.

García del Campo found many similar cases. An Irish holidaymaker, William Smyth, 66, died in April 2016 from multi-organ failure after being prescribed Nolotil for shoulder pain. Mary Ward, 59, who lived in Spain, died in March 2006 after receiving Nolotil following surgery in Marbella and contracting agranulocytosis and complications. In another case, a woman in her 60s required amputations after taking the drug and developing sepsis.

Agranulocytosis is said to be an extremely rare reaction to metamizole, but García del Campo was soon flooded with reports. She said the cases appeared to show that the British and Irish communities were more sensitive. A study from April 2009 had investigated 13 cases of agranulocytosis involving dipyrone (another name for metamizole) at the Costa del Sol Hospital in Marbella, five of which involved British people. It concluded: “Dipyrone-related agranulocytosis is a side effect that is more common in the UK population and its use should be avoided.”

The ADAF presented evidence in its case from a regional health officer who said a local survey of five health departments in Spain “surprisingly” found that the British population has a sensitivity to metamizole in the order of “80 to 120 times higher” then Spanish. That report has not yet been published and there is as yet no comprehensive and robust epidemiological evidence to support the theory that British or Irish people may be more sensitive to the drug’s side effects.

In April 2018, 75-year-old Lorna Vincent, who lived in Spain, went to hospital in Benidorm for surgery to repair a small hole in her intestine. Her daughter, Kim Glasby, 59, from Brixham, Devon, said the operation appeared to be a success and she was given metamizole as a painkiller but then became seriously ill. Glasby said: “The surgeon told me that she did not have enough white blood cells and that she was not responding to painkillers. They didn’t know what to do.”

Vincent died on April 18; her family was told she was suffering from multi-organ failure. Glasby believes in light of other cases that a reaction to metamizole was the cause and is now trying to obtain all of her mother’s medical records.

In October 2018, less than a year after García del Campo started her campaign, the Spanish Agency for Medicines and Health Products, AEMPS, released new guidelines for metamizole. It recommended that its use in tourists (described as the “floating population”) should be avoided and that patients should be advised of symptoms of agranulocytosis.

García del Campo says the new guidelines have been widely violated. She said patients were not warned of the risks and the drug could be obtained without the required prescription.

Carla Cardwell, 41, originally from Britain and now living in Gibraltar, gave birth to her son Caiden by caesarean section in December 2019, just across the Spanish border in the town of La Línea. She was given a prescription for metamizole.

She became so ill in January 2020 that she went to a nearby emergency department in Gibraltar. “They thought I had cancer because I had no white blood cells at all,” she said. “The advisors said, ‘We don’t know what’s going on. You have the blood tests of someone with cancer, but you don’t have cancer.’”

A senior doctor who reviewed her case asked if she had recently used metamizole. She said yes, and agranulocytosis was diagnosed. She was told she needed injections of granuloctye colony stimulating factor (G-CSF) to regenerate her bone marrow.

She said: “My pancreas, liver and intestines were all infected. The injections had to be flown to the hospital and were the worst. I could even feel the pain in my eye sockets. I will be forever grateful to the counselor who saved my life.” She received therapy for post-traumatic stress after her ordeal. According to her medical records, she suffered from agranulocytosis, with metamizole as the suspected cause.

The ADAF’s legal action against the Spanish Ministry of Health and the AEMPS says the drug is being offered to patients without proper controls. It calls for a ban on giving the drug to citizens from countries where metamizole has been withdrawn and for a new analysis of the risk factors related to agranulocytosis. It also says that the information sheet for the drug needs to be revised.

Francisco Almodóvar, the lawyer representing ADAF, said: “We have testimonials from British people telling their stories. We can support the evidence with clinical data. It is a very important public health issue.”

The company that makes Nolotil, Boehringer Ingelheim, said: “Nolotil is a prescription medicine. The ingredient metamizole has been used by patients for almost 100 years, with an established and well-known safety profile.

“Agranulocytosis is described in the current prescribing information as a very rare side effect. It has been a known side effect for decades and available scientific information has confirmed the known safety profile of metamizole.

‘The side effect of agranulocytosis is addressed in the current product information. The current prescribing information adequately addresses current knowledge of the risks associated with the use of Nolotil. We welcome any information that helps us improve the benefit-risk profile and safe use of our medicines.”

The AEMPS referred the Observer to the Spanish Ministry of Health, which did not respond to a request for comment.