Families are calling for a popular painkiller in Spain to be completely banned in the country following numerous deaths and severe reactions in British people who had taken the drug.
The painkiller metamizole, commonly known in Spain under the brand name Nolotil, has a known adverse reaction as a possible side effect called agranulocytosis, which affects a small percentage of people and causes a rapid drop in white blood cells and sepsis (blood poisoning).
Available data confirms there is an increased risk in elderly people – although it also shows an increase in the use of the painkiller among elderly patients.
Metamizole, which is widely used in Spain as a painkiller for different situations for moderate to severe acute pain, has been marketed in Spain for more than 50 years and is available under different trade names including Nolotil.
The painkiller is not available in the UK and is banned in many countries, including the US, due to its potential for adverse effects. In the US, approval was withdrawn in 1977. But the painkiller remains widely prescribed in Spain, with data showing its use has doubled in the last 10 years.
In October, the Spanish Health Ministry issued a warning against its use on those visiting the country for a short time, following reports to Spanish authorities of multiple people from the UK and Ireland dying after taking the painkiller. The guidance states: “Do not use metamizole in patients where controls are not possible - eg floating population.”
However, a campaigner whose investigations prompted the new guidelines claims they are not being taken seriously enough by doctors and pharmacists.
Cristina Garcia del Campo, a medical and legal translator who lives in Spain, told HuffPost UK she is now fighting for a complete ban of Nolotil in Spain as she fears more British people may suffer.
She first began investigating the potential adverse effects of Nolotil about 18 months ago, and has revealed to HuffPost UK she has now collated more than 200 cases of British people who she says have been severely affected by Nolotil, including more than 20 deaths linked to patients who had taken the painkiller.
Her findings resulted in the new guidance being issued after she took the cases to Spain’s Agency of Medicines and Medical Devices (AEMPS).
Garcia del Campo, who is from Madrid, told HuffPost UK she first began investigating Nolotil in December 2017 after becoming suspicious about the number of cases of sepsis among Britons.
She said: “In my job as medical translator, I go into hospitals a lot with British patients. In December 2017, I had a particular client who had sepsis, and I remember thinking it wasn’t the first time I had heard of someone having sepsis.
“This set the alarm bells ringing so I started to investigate and got out all my reports of patients affected by sepsis. I realised what they all had in common was that they were British and they had all taken Nolotil.”
She added: “I was shocked and I knew of about five cases at this point. Little did I realise I would end up with hundreds of cases when I began this investigation.”
As well as being a medical translator for British patients and their families, Garcia de Campo acts as the patient liaison, organising appointments and admissions people on behalf of her clients.
Garcia del Campo has now travelled all over Spain talking to experts and gathering information.
She explained: “Metamizole – the generic name for Nolotil – has been banned in the US, Japan, Australia and other countries and it is not licensed in the UK.
“One of the side effects of Nolotil is agranulocytosis, where the bone marrow does not produce enough white cells and they often go down to zero.
“This makes the patient extremely susceptible to infections they cannot fight and they can end up dying or with amputations or suffering other life long consequences.
“I put a post on social media asking if anyone had had an adverse reaction to the drug and people began contacting me telling me about their terrible experiences.”
Although there are no conclusive studies, many health specialists suspect people from Northern Europe are more at risk to metamizole than people from Spain.
A study was carried out by health professionals at Costa del Sol Hospital in Marbella in 2009 looking into their cases of agranulocytosis analysing the connection with metamizole. This study discovered the rate was almost three times higher among foreigners than in Spanish people.
Although the vast majority of the cases Garcia del Campo has collated involve British patients, her findings have also unearthed Spanish cases. “I have collated more than 40 cases of Spanish people being affected by Nolotil, and between five and 10 deaths. There was a death of a Spanish person who had taken Nolotil only a few weeks ago.”
Garcia del Campo took her findings to Spain’s Agency of Medicines and Medical Devices on July 6 2018 and shared her information with them.
Following this, she was invited to a summit with experts, which resulted in the new guidance being issued on October 30 2018 – with the warning stating Nolotil should not be given to people who can’t be monitored, such as tourists.
However, Garcia del Campo believes hospitals and pharmacies are not abiding by the updated recommendations.
She says that since the updated guidance, she has been contacted by a number of people of British origin telling her that they were either given Nolotil in hospital or were about to be given it and refused it. She claims she is aware of at least six cases of serious adverse reactions to Nolotil since October 30 2018 when the updated guidance was issued.
Garcia del Campo said: “It is good that they took notice and issued this warning. But hospitals and pharmacies in Spain are not taking it seriously enough.”
British victims and families of those who have died after taking the painkiller told HuffPost UK they want to see Nolotil banned outright in Spain.
‘It’s Too Late For Our Dad But We Want To Prevent Further Deaths From This Painkiller’
After working hard all his life as an engineer and then a university teacher, Stuart Holgate and wife Sallie of Shipley, Bradford, decided to move to Spain. The couple were living in Almeria and enjoying their retirement – until Stuart, 73, died in July last year after suffering a severe reaction to Nolotil.
His daughter, Jane Wheildon, 43, who lives in Bradford, recalls how treatment for a chest infection uncovered an abscess on her father’s lung caused by undiagnosed kidney cancer.
In May 2018, Holgate had an operation in Almeria, Spain, to remove his kidney. Wheildon said: “My dad had a huge scar but was recovering well. Me and my sister went out to Spain and as my dad had a bit of pain after the surgery, I took him to the pharmacy in the village to get some pain relief.
“He recognised the Nolotil as he had had it in hospital so they gave him some tablets.”
Holgate became unwell, had difficulty breathing and was in pain. He was admitted to hospital where doctors told the family he had suffered a reaction to something.
“When we said he had taken Nolotil, the doctors said: ‘That will be why.’ The painkiller had caused a reaction which had wiped out my dad’s white blood cells and he got sepsis as he could not fight any infection.”
He died a few weeks later.
Wheildon said: “We were totally devastated. My dad had got through the cancer and was recovering well and then a simple painkiller he bought over the counter caused this horrendous reaction.”
‘I’ve Had The Majority Of My Feet And Some Of My Fingers Amputated – But I Just Feel Lucky To Be Alive’
Warning: This story contains some images which readers may find distressing
Joan Judge, originally from Scotland, has lived in Spain for 42 years. The 63-year-old, who was working as a teacher in international schools in Spain, almost died after being prescribed Nolotil as pain relief for a severe urinary infection.
Judge told HuffPost UK: “I had this severe urinary infection and went to A&E and was given Nolotil for the pain.
“Unfortunately, I had the reaction which wipes out all your white blood cells, but at the time, we didn’t know what had happened.
“Within a few days of taking the Nolotil, I was barely conscious and my husband rang an ambulance and I was taken to a local hospital.
“Doctors seemed to think I had leukaemia because of my low white blood count.”
Judge was transferred to the University Hospital in Malaga. As soon as a doctor was told she had taken Nolotil, he realised what had happened. “At that point, the reaction some people have to it was not widely known.”
Judge regained consciousness but needed dialysis for a week as her kidneys had stopped working. She also had gangrene affecting her hands, feet, the tip of her nose and ears. This led to her having most of both her feet amputated, as well as some of her fingers.
Judge told HuffPost UK: “It is awful what happened to me, but I just feel lucky I survived and am still here.
“It took me a year to get to what is now my normality. I went back to work for a while, but only part-time.
“I can still walk and most people don’t realise anything is amiss. But because of the amount of feet I am missing, my balance is not great.”
Judge wants to see Nolotil banned completely in Spain and claims that even after the new directive, British people are still being given the painkiller.
She said: “The British husband of one of my friends was in hospital in Malaga a few weeks ago and he was prescribed Nolotil. It is frightening.
“I do not blame the doctor who gave me Nolotil as he had no idea of the effect it would have on me and was trying to help me.
“But it seems incredible that even after a directive from the medical world in Spain, people from British origin are still being prescribed Nolotil.
“It is banned in so many countries and there is obviously a reason for this. I think the best thing that can happen is for it to be completely banned in Spain.”
‘I Was In A Coma For 6 Weeks After Taking Nolotil And Feel I Cheated Death’
Paddy Clancy suffered septic shock after being given metamizole following a shoulder operation – and ended up in an induced coma for six weeks on a life support machine.
The 75-year-old and his wife Julie are originally from Surrey but moved to Spain 18 years ago. The great-grandfather told HuffPost UK how he was given Noloti as a painkiller in September 2017.
Days later, he began feeling ill and was rushed into intensive care after his health deteriorated and his body began shutting down.
He was put into an induced coma and his white blood count plummeted and he developed sepsis.
Clancy said: “They had to put me into an induced coma as my body was shutting down – my kidneys were the first to go.
“I had dialysis and blood transfusions and then because my immune system had totally gone, I picked up hospital infections.
“The doctors actually asked Julie if I had been on Nolotil, but she told them that no, it was a different drug I had taken as a painkiller. But it was the same thing – just a different brand name.
“They put me on various antibiotics, but I wouldn’t respond. Eventually, they found one that worked.
“I was in an induced coma for six weeks, followed by a couple more weeks in hospital then I went to a rehabilitation hospital.
“Recovery was slow and doctors said the only thing that saved me was that I was so fit and healthy before.”
Clancy still suffers from symptoms including extreme fatigue, burning sensations in his fingers and toes and has suffered from depression.
He told HuffPost UK: “I believe I cheated death and far from having recovered, I feel I survived. I am very lucky to be alive but will never be the same person again.
“I have bouts of uncertainty and it has affected my brain.
“Taking Nolotil altered my life and I strongly feel it should be banned.”
Spain’s Agency of Medicines and Medical Devices (AEMPS) reviewed cases of agranulocytosis and the use of metamizole and issued a reminder it should only be purchased with a doctor’s prescription.
The updated guidance for healthcare professionals states: “The AEMPS has reviewed the situation in Spain due to the recent notification to the Spanish Pharmacovigilance System of cases of agranulocytosis, particularly in patients of British origin.
“The AEMPS has consulted the Safety Committee for Medicinal Products for Human Use and clinical experts on this matter.”
The information also reveals that the use of metamizole in Spain based on prescriptions data has doubled in the last 10 years with the most marked increase being in the last five years.
The updated information by the AEMPS added: “Although it has been discussed for several years about increased susceptibility to agranulocytosis in the population of Northern Europe and certain genetic factors have been studied, with the available information, it is not possible to rule out or confirm a higher risk in populations with specific characteristics.”
The updated recommendations in Spain state that metamizole should only be used for short term treatments at the minimum effective doses and that patients should be monitored. If prolonged treatment is necessary, it is recommended to carry out periodic blood tests.
The new guidance also says before metamizole is prescribed, a detailed look at the patient’s medical history should be carried out to make sure its use is avoided in patients with agranulocytosis risk factors.
The information for healthcare professionals also advises informing the patient to stop treatment if they suffer any signs or symptoms suggestive of the adverse reaction.
It then states that metamizole should not be used in patients in whom these controls are not possible – such as those visiting the country as tourists.
A spokesman from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK confirmed to HuffPost UK that metamizole is not licensed in the UK and is not available.
They said they were unable to comment on the regulatory situation of the drug outside of the UK.
Boehringer Ingelheim, the manufacturer of Nolotil, gave this statement to HuffPost UK:
“Metamizole is a prescription drug indicated for the treatment of moderate to severe pain and fever and has been used in this indication since the 1950s.
“Metamizole is available under different brand names by different pharmaceutical suppliers across Europe and internationally.
“As with all medications there are known risks associated with use. These possible adverse drug reactions have been well described in the more than 60 years of experience with drugs containing metamizole.
“Boehringer Ingelheim sees the wellbeing and safety of patients as the highest priority and takes any report of adverse drug reactions very seriously.
“We put all measures in place to detect and report any adverse drug reaction to the national competent authorities. The final decision about the risk/benefit ratio remains with these authorities.
“In our interaction with the AEMPS in Spain, Boehringer Ingelheim have shared and continue to do so on an ongoing basis, all available data on the use of Metamizole (Nolotil) and the agency has recently published, in November 2018, its guidance based on the available scientific data and its own assessment .
“We are fully aligned with the November 2018 recommendations of the AEMPS which is reflected in the latest versions of the Summary of Product Characteristics (detailed information for Healthcare Professionals) and for patients (in the Patient Information Leaflet) of Nolotil that has been approved by the AEMPS.”
Have you or a loved one suffered an adverse experience with Nolotil? Share your story with Aasma Day at: aasma.day@huffpost.com