Nolotil: The activist warning foreigners in Spain about a dangerous painkiller
The Local speaks to Cristina García Del Campo, a medical translator turned researcher who for years has fought to get Spain to ban a popular painkiller with potentially lethal side effects for Britons and other Northern Europeans in particular.
What is Nolotil?
Nolotil is a painkiller, the go-to painkiller and most sold medicine in Spain. In fact, in Spanish hospitals and healthcare centres the rule is: “if in pain, give Nolotil”.
It is a different type of painkiller, it is not an anti-inflammatory or an opioid and it is not like Paracetamol. It is a pyrazolone. Its active ingredient is Metamizole and it is sold under different names, but Nolotil is the most popular one in Spain.
When it was first introduced in Spain, it was considered to be so toxic that it was only given in hospitals and under very strict supervision. Why did it go from that to being the most sold medicine in the country?
Why is Nolotil controversial?
Nolotil became very controversial when, in the 1970s, it was discovered that it could cause agranulocytosis, a severe reduction in the number of white cells which can be fatal. It was known that it could cause a lot of side effects, but agranulocytosis was its most feared side effect and, even though it was considered to be very rare, the fact that it could cause death was enough for many countries to decide to get it banned.
Nowadays, Nolotil is prohibited in around 40 countries, included the UK, the United States, Japan , Australia and many countries in Europe. In Sweden, the ban was lifted in 1995 and re-introduced in 1999 only to be taken off the market again just a few years later because of cases of agranulocytosis.
What has your research into Nolotil involved and why did you choose to embark on this mission?
One of my clients, who I translated for, suddenly became very ill and died in December 2017. His name was James and he was Irish.
Before he died, I spent hours at the hospital with him. Fournier’s Gangrene and sepsis were mentioned. At the time, I remember thinking that was not the first time I had heard the word sepsis and James was not the first British or Irish patient to have died suddenly.
I started to wonder why this was happening and, one Saturday evening, on 9th Dec 2017, I sat at my dining-room table at home and started going through some medical reports I had from patients. It was then when I realised they all had one thing in common: they had all taken Nolotil.
I then remembered that a British friend of mine had told me Nolotil was banned in the UK and I decided to look for more possible cases on the internet. I found three more cases of British or Irish people who had either died or been severely affected by this drug.
I was taking Nolotil for a toothache at the time so I quickly went to get my box of Nolotil and started reading the patient information leaflet. And there it was! Sepsis, Fournier’s Gangrene, necrotising fasciitis, agranulocytosis…
I was shocked and nervous and started printing all the information. Until then, I had always been a great believer in Nolotil, like most Spanish people. Nolotil is part of our culture, something you are always supposed to have at home and you cannot live without. It is imprinted in our brains as a necessary thing and a lifesaver and, since I had never heard anything negative about it before, I was in shock. I kept thinking: “surely doctors must know about this… but if they did, why would they give it to people?” First thing on Monday morning, I turned up at the hospital and said: “I think we have a public health problem caused by Nolotil”.
What have been your primary findings?
When James became so ill, during the hours I spent at the hospital with him, I used to think that getting a sudden infection and dying or nearly dying did not seem an uncommon thing. I started thinking about other cases: a client, and friend, of mine had very suddenly died of an infection four years before and that was also a shock, as all this man had was gallstones and was waiting for an operation. He was prescribed Nolotil while he waited for his operation and never made it to the operation. He developed a terrible infection two days before he was due for surgery, went into septic shock and died on the day his surgery was due.
https://www.youtube.com/watch?v=2VqP8ffQ1Hw
I also had a friend/ client who had had an operation and a few weeks later, he developed a very high temperature for no apparent reason. I remember talking to his wife about his temperature and thinking: “I must watch out for Steve, from previous experience with other patients, I know that when people get a temperature, for no apparent reason, within a month of having surgery, it may be sepsis”. I had this feeling that we could not wait and made his wife get him out of bed in the middle of the night to take him to the Emergency Department... He had sepsis and I was told had we waited until the next morning, he would not have made it…. When I looked in his notes, I also found he had been taking Nolotil after his operation.
Just around the time when James died, I also remember a friend of mine telling me there was a man in hospital dying of sepsis. This happened just as I was starting to research so I quickly asked her if this man had been taking Nolotil and the reply was he had taken Nolotil following a shoulder operation. This man spent two months in a coma in intensive care, fighting for his life, and one month in a different hospital learning to walk again.
Little by little, I realised all these cases had several things in common: they were all British or Irish, they had all taken Nolotil for pain before or after surgery and they had all become very ill very suddenly. Little did I know this was only the beginning of a huge campaign.
What have you achieved so far and what are your future goals?
I started joining Expats Groups on Facebook, as I thought there had to be more cases out there and I just did not know how to reach out to these people. As cases started to come in, I decided to create my own Facebook page, solely for this purpose, which I called Cristina Research Information.
Once I had collected 100 cases, I spoke to the AEMPS (Spanish Agency of Medicines and Medical Products) and told them I wanted to come and see them in Madrid with all my cases. I took the train to Madrid and had my first meeting with them on 6th July 2018. They were shocked when they saw all my cases, backed up by medical reports stating “agranulocytosis due to Nolotil / Metamizole”, and said: “We’ve got to stop giving Nolotil to these population groups!”.
https://www.youtube.com/watch?v=GssFDpdJzTA
I submitted cases to them throughout the summer, often going to bed between 4:00 and 6:00 am and then having to work the following day, but, following my work, the directors from the AEMPS decided to invite me to a Drug Safety Committee Meeting in Madrid on 26th Sept 2018, where I spoke in front of a large number of doctors.
As a result, the AEMPS issued a directive on 30/10/2018, banning Nolotil for tourists and tightening guidelines.
Unfortunately, these guidelines were not enough, as we have continued to get Nolotil cases but the AEMPS has done nothing else about it.
I know for a fact that many lives have been saved due to me raising awareness through my Facebook page and my campaign.
People who were in hospital dying have been saved because someone had heard about my Nolotil campaign and told the doctor who was giving Nolotil to the patient, the doctor stopped giving the patient Nolotil and the patient recovered, in some cases after a month.
This has happened to an awful lot of people and not just in Spain, but also in Germany and other countries, as my campaign has raised awareness worldwide. I now have over 350 cases, most of them British, but 63 of them are Spanish, which would indicate that, due to a genetic component, the British are more at risk, but other nationalities are not immune to its deadly effects.
I am now officially registered as a “researcher” and, in April 2021, I wrote an article with a team of medical experts and it was published in medical journals. The reason for this article was to highlight the inadequacy of the measures taken by the AEMPS.
Over the last four years, I have notified hundreds of Nolotil cases to the AEMPS and I have asked them on numerous occasions to take tougher measures. Not only have they not replied to any of my messages, but they also decided to include Nolotil on the list of essential medicines during Covid.
I know the only reason why many people have managed to avoid taking it, or have survived its effects, is because of my campaign, not because of the AEMPS.
Doctors keep prescribing or giving Nolotil to people against their will, which means they are violating patients’ rights.
For this reason, as it is obvious that the prescription of Nolotil cannot be controlled and it continues to affect people, I have asked for Nolotil to be banned, at least for people from countries where it is already banned, and for tougher guidelines for the rest.
Cristina's hard work and activism have not only helped save lives, but led to wider coverage in the Spanish press about the potential side effects of Nolotil. Screenshot: Google
I have also filed a formal complaint with the Ombudsman against the AEMPS and the Ministry of Health because of their lack of action, resulting in patients’ rights being violated and people’s lives being put at risk.
After studying all the information I submitted, the Ombudsman decided to accept my complaint and launched an investigation asking the AEMPS to provide a full report. The AEMPS has been given 15 days to submit this report and I am currently waiting to hear from the Ombudsman, who will be taking it to Parliament if the AEMPS does not submit the report they are obliged to.
What advice would you like to give foreigners (and Spaniards) in Spain regarding Nolotil?
A lot of people ask not to be given Nolotil and, despite this, doctors give it or prescribe it to them against their will. I would advise people to register, in writing, at hospitals and healthcare centres their wish not to be given Nolotil/Metamizol, stating that should they be given it against their will, they will hold the doctor responsible for any consequences.
I would also advise people to ask for a blood test to check their white cell count if they are given Nolotil/Metamizol. But be aware, the effects of Nolotil are unpredictable. According to the datasheet and the cases I have compiled through my research, Nolotil can affect anybody anytime, regardless of whether they have taken one capsule or seven, even if they have taken it before without a problem.
As well as the potentially fatal agranulocytosis, it can also cause many other side effects, such us liver or kidney damage, anaphylactic shock, hypotension, etc.
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See Also
What is Nolotil?
Nolotil is a painkiller, the go-to painkiller and most sold medicine in Spain. In fact, in Spanish hospitals and healthcare centres the rule is: “if in pain, give Nolotil”.
It is a different type of painkiller, it is not an anti-inflammatory or an opioid and it is not like Paracetamol. It is a pyrazolone. Its active ingredient is Metamizole and it is sold under different names, but Nolotil is the most popular one in Spain.
When it was first introduced in Spain, it was considered to be so toxic that it was only given in hospitals and under very strict supervision. Why did it go from that to being the most sold medicine in the country?
Why is Nolotil controversial?
Nolotil became very controversial when, in the 1970s, it was discovered that it could cause agranulocytosis, a severe reduction in the number of white cells which can be fatal. It was known that it could cause a lot of side effects, but agranulocytosis was its most feared side effect and, even though it was considered to be very rare, the fact that it could cause death was enough for many countries to decide to get it banned.
Nowadays, Nolotil is prohibited in around 40 countries, included the UK, the United States, Japan , Australia and many countries in Europe. In Sweden, the ban was lifted in 1995 and re-introduced in 1999 only to be taken off the market again just a few years later because of cases of agranulocytosis.
What has your research into Nolotil involved and why did you choose to embark on this mission?
One of my clients, who I translated for, suddenly became very ill and died in December 2017. His name was James and he was Irish.
Before he died, I spent hours at the hospital with him. Fournier’s Gangrene and sepsis were mentioned. At the time, I remember thinking that was not the first time I had heard the word sepsis and James was not the first British or Irish patient to have died suddenly.
I started to wonder why this was happening and, one Saturday evening, on 9th Dec 2017, I sat at my dining-room table at home and started going through some medical reports I had from patients. It was then when I realised they all had one thing in common: they had all taken Nolotil.
I then remembered that a British friend of mine had told me Nolotil was banned in the UK and I decided to look for more possible cases on the internet. I found three more cases of British or Irish people who had either died or been severely affected by this drug.
I was taking Nolotil for a toothache at the time so I quickly went to get my box of Nolotil and started reading the patient information leaflet. And there it was! Sepsis, Fournier’s Gangrene, necrotising fasciitis, agranulocytosis…
I was shocked and nervous and started printing all the information. Until then, I had always been a great believer in Nolotil, like most Spanish people. Nolotil is part of our culture, something you are always supposed to have at home and you cannot live without. It is imprinted in our brains as a necessary thing and a lifesaver and, since I had never heard anything negative about it before, I was in shock. I kept thinking: “surely doctors must know about this… but if they did, why would they give it to people?” First thing on Monday morning, I turned up at the hospital and said: “I think we have a public health problem caused by Nolotil”.
What have been your primary findings?
When James became so ill, during the hours I spent at the hospital with him, I used to think that getting a sudden infection and dying or nearly dying did not seem an uncommon thing. I started thinking about other cases: a client, and friend, of mine had very suddenly died of an infection four years before and that was also a shock, as all this man had was gallstones and was waiting for an operation. He was prescribed Nolotil while he waited for his operation and never made it to the operation. He developed a terrible infection two days before he was due for surgery, went into septic shock and died on the day his surgery was due.
https://www.youtube.com/watch?v=2VqP8ffQ1Hw
I also had a friend/ client who had had an operation and a few weeks later, he developed a very high temperature for no apparent reason. I remember talking to his wife about his temperature and thinking: “I must watch out for Steve, from previous experience with other patients, I know that when people get a temperature, for no apparent reason, within a month of having surgery, it may be sepsis”. I had this feeling that we could not wait and made his wife get him out of bed in the middle of the night to take him to the Emergency Department... He had sepsis and I was told had we waited until the next morning, he would not have made it…. When I looked in his notes, I also found he had been taking Nolotil after his operation.
Just around the time when James died, I also remember a friend of mine telling me there was a man in hospital dying of sepsis. This happened just as I was starting to research so I quickly asked her if this man had been taking Nolotil and the reply was he had taken Nolotil following a shoulder operation. This man spent two months in a coma in intensive care, fighting for his life, and one month in a different hospital learning to walk again.
Little by little, I realised all these cases had several things in common: they were all British or Irish, they had all taken Nolotil for pain before or after surgery and they had all become very ill very suddenly. Little did I know this was only the beginning of a huge campaign.
What have you achieved so far and what are your future goals?
I started joining Expats Groups on Facebook, as I thought there had to be more cases out there and I just did not know how to reach out to these people. As cases started to come in, I decided to create my own Facebook page, solely for this purpose, which I called Cristina Research Information.
Once I had collected 100 cases, I spoke to the AEMPS (Spanish Agency of Medicines and Medical Products) and told them I wanted to come and see them in Madrid with all my cases. I took the train to Madrid and had my first meeting with them on 6th July 2018. They were shocked when they saw all my cases, backed up by medical reports stating “agranulocytosis due to Nolotil / Metamizole”, and said: “We’ve got to stop giving Nolotil to these population groups!”.
https://www.youtube.com/watch?v=GssFDpdJzTA
I submitted cases to them throughout the summer, often going to bed between 4:00 and 6:00 am and then having to work the following day, but, following my work, the directors from the AEMPS decided to invite me to a Drug Safety Committee Meeting in Madrid on 26th Sept 2018, where I spoke in front of a large number of doctors.
As a result, the AEMPS issued a directive on 30/10/2018, banning Nolotil for tourists and tightening guidelines.
Unfortunately, these guidelines were not enough, as we have continued to get Nolotil cases but the AEMPS has done nothing else about it.
I know for a fact that many lives have been saved due to me raising awareness through my Facebook page and my campaign.
People who were in hospital dying have been saved because someone had heard about my Nolotil campaign and told the doctor who was giving Nolotil to the patient, the doctor stopped giving the patient Nolotil and the patient recovered, in some cases after a month.
This has happened to an awful lot of people and not just in Spain, but also in Germany and other countries, as my campaign has raised awareness worldwide. I now have over 350 cases, most of them British, but 63 of them are Spanish, which would indicate that, due to a genetic component, the British are more at risk, but other nationalities are not immune to its deadly effects.
I am now officially registered as a “researcher” and, in April 2021, I wrote an article with a team of medical experts and it was published in medical journals. The reason for this article was to highlight the inadequacy of the measures taken by the AEMPS.
Over the last four years, I have notified hundreds of Nolotil cases to the AEMPS and I have asked them on numerous occasions to take tougher measures. Not only have they not replied to any of my messages, but they also decided to include Nolotil on the list of essential medicines during Covid.
I know the only reason why many people have managed to avoid taking it, or have survived its effects, is because of my campaign, not because of the AEMPS.
Doctors keep prescribing or giving Nolotil to people against their will, which means they are violating patients’ rights.
For this reason, as it is obvious that the prescription of Nolotil cannot be controlled and it continues to affect people, I have asked for Nolotil to be banned, at least for people from countries where it is already banned, and for tougher guidelines for the rest.
I have also filed a formal complaint with the Ombudsman against the AEMPS and the Ministry of Health because of their lack of action, resulting in patients’ rights being violated and people’s lives being put at risk.
After studying all the information I submitted, the Ombudsman decided to accept my complaint and launched an investigation asking the AEMPS to provide a full report. The AEMPS has been given 15 days to submit this report and I am currently waiting to hear from the Ombudsman, who will be taking it to Parliament if the AEMPS does not submit the report they are obliged to.
What advice would you like to give foreigners (and Spaniards) in Spain regarding Nolotil?
A lot of people ask not to be given Nolotil and, despite this, doctors give it or prescribe it to them against their will. I would advise people to register, in writing, at hospitals and healthcare centres their wish not to be given Nolotil/Metamizol, stating that should they be given it against their will, they will hold the doctor responsible for any consequences.
I would also advise people to ask for a blood test to check their white cell count if they are given Nolotil/Metamizol. But be aware, the effects of Nolotil are unpredictable. According to the datasheet and the cases I have compiled through my research, Nolotil can affect anybody anytime, regardless of whether they have taken one capsule or seven, even if they have taken it before without a problem.
As well as the potentially fatal agranulocytosis, it can also cause many other side effects, such us liver or kidney damage, anaphylactic shock, hypotension, etc.
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