by A patients group representing several British victims has launched legal action against the Spanish government over accusations that it failed to protect people against the potentially fatal side effects of one of the country’s most popular painkillers, implicated in a number of diseases and serious deaths.
The drug metamizole, commonly sold in Spain under the brand name Nolotil, is banned in several countries, including Britain, the United States, India and Australia. It can cause a condition known as agranulocytosis, which reduces white blood cells, increasing the risk of a potentially fatal infection.
The Association of Patients Affected by Medicines (ADAF) says adverse reactions to medicines have led to sepsis, organ failure and amputations. It has identified around 350 suspected cases of agranulocytosis between 1996 and 2023, including those of 170 Britons who live in Spain or were on holiday there.
The ADAF is examining more than 40 deaths in which it believes the drug may have caused or contributed to the death. The patient group says case reports, including a 2009 study, suggest the British population may be more susceptible to the drug’s side effects, but this has not been confirmed by an independent scientific study.
The group demands an investigation into the drug and new controls. He presented his appeal on November 14 before the National Court of Madrid. Cristina García del Campo, founder of the organization, stated: “This drug has destroyed people’s lives and now it should be withdrawn. A woman took three pills and part of her feet and several fingers were amputated. Even if she doesn’t kill you, once you’ve had sepsis your body is never the same again.”
Metamizole was first produced commercially 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 It was withdrawn in about 30 countries, but is still widely available throughout the EU.
Studies have shown a dramatic variation in the estimated incidence of agranulocytosis in response to the drug, from approximately one in 2000 to less than 1.1 per million users. A European Medicines Agency report from 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, began investigating when one of her clients, an Irishman, became seriously ill, with infections racking his body. She was admitted to the hospital in the city of Dénia and died on November 18, 2017 due to sepsis and multiple organ failure.
She said: “I was the last person with him and I held his hand. The whole time I was with him I kept asking: ‘Why is this happening? How could someone go from being fine to having this terrible infection?’”
He began compiling recent worrying reports he had heard locally about agranulocytosis and sepsis. One night in December 2017, she laid out all the files and medical notes she had gathered on six cases. Then she realized: all the people involved had been taking metamizole.
One of the patients in García del Campo’s file, Paddy Clancy, 80, a British expatriate 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 put him in an induced coma to give his body the best chance to fight the infection.
Clancy said: “My wife was told, ‘Your kidneys are filling up and your organs are shutting down.’ They thought maybe she wouldn’t make it through the weekend.” The family was told that her body’s white blood cells, which normally fight infections, had been severely depleted.
Clancy came out of a coma after 39 days. He had lost 22 kg and could not stand, but little by little he recovered. His history confirms the disorder that almost killed him: “metamizole-associated agranulocytosis.”
García del Campo found many similar cases. An Irish tourist, William Smyth, 66, died in April 2016 due to multiple organ failure after being prescribed Nolotil for shoulder pain. Mary Ward, 59, who lived in Spain, died in March 2006 after she was given Nolotil following an operation in Marbella and contracted 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 inundated with reports. He said the cases appeared to show the British and Irish community were more susceptible. A study from April 2009 examined 13 cases of agranulocytosis related to dipyrone (another name for metamizole) at the Costa del Sol Hospital in Marbella, five of which affected Britons. He concluded: “Dipyrone-related agranulocytosis is a more common adverse effect in [the] British population, and its use should be avoided.”
The ADAF has presented evidence in its case from a regional health official who says that a local study in five health departments in Spain had “surprisingly” found that the British population had a susceptibility to metamizole in the order of “80 to 120 times greater “than Spanish. That report has not been published and to date there is no complete and robust epidemiological evidence to support the theory that British or Irish people may be more susceptible to the drug’s side effects.
In April 2018, Lorna Vincent, 75, who lived in Spain, was admitted to a hospital in Benidorm to undergo surgery to repair a small hole in her intestine. Her daughter, Kim Glasby, 59, from Brixham, Devon, said the operation seemed a success and she was given metamizole as a painkiller, but she then fell seriously ill. Glasby said: “The surgeon told me she didn’t have enough white blood cells and she wasn’t responding to painkillers. They did not know what to do”.
Vicente died on April 18; His family was told that he was suffering from multiple organ failure. Glasby believes, in light of other cases, that a reaction to metamizole was to blame and now he is trying to obtain all of his mother’s medical records.
In October 2018, less than a year after García del Campo started his campaign, the Spanish Agency for Medicines and Health Products, AEMPS, published new guidelines for metamizole. It recommended avoiding its use in tourists (described as the “floating population”) and warning patients about the symptoms of agranulocytosis.
García del Campo says the new guidelines have been widely flouted. He said patients were not warned about the risks and the drug could be obtained without the required prescription.
Carla Cardwell, 41, originally from the United Kingdom and now living in Gibraltar, gave birth to her son, Caiden, in December 2019 by cesarean section, across the Spanish border, in the town of La Línea. She was prescribed metamizole.
In January 2020 he became so ill that he went to a nearby emergency unit in Gibraltar. “They thought she had cancer because she didn’t have any white blood cells,” she said. “The consultants said, ‘We don’t know what’s wrong. You have the blood results of someone with cancer, but you don’t have cancer.’”
An experienced doctor who examined his case asked him if he had been taking metamizole recently. She said she did and was diagnosed with agranulocytosis. She was told that she needed injections of granulocyte colony-stimulating factor (G-CSF) to regenerate her bone marrow.
She said: “My pancreas, liver and intestine were all infected. The injections had to be flown to the hospital and were the worst part. I could even feel the pain in my eye sockets. “I will be eternally grateful to the consultant who saved my life.” After her ordeal, she received therapy for post-traumatic stress disorder. Her medical history indicates that she suffered from agranulocytosis, and metamizole is suspected to be the cause.
ADAF’s legal action, against the Spanish Ministry of Health and the AEMPS, affirms that the medicine is offered to patients without adequate controls. It calls for a ban on administering the drug to citizens of countries where metamizole has been withdrawn and for a new analysis of the risk factors related to agranulocytosis. It also says that it is necessary to review the medication information sheet.
Francisco Almodóvar, the lawyer representing ADAF, said: “We have testimonies from British people telling their stories. We can support the evidence with clinical records. “It is a very important public health problem.”
The company that makes Nolotil, Boehringer Ingelheim, said: “Nolotil is a prescription drug. Its ingredient metamizole has been used by patients for almost 100 years, with an established and well-known safety profile.
“Agranulocytosis is described as a very rare adverse reaction in current prescribing information. It is an adverse reaction known for decades and the 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 regarding 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 sent the Observer to the Spanish Ministry of Health, which did not respond to a request for comment.
