Irish and British holidaymakers and expatriates in Spain warned to avoid popular painkiller, writes Colin Gannon
Irish and British visitors to Spain have been warned to avoid a commonly available painkiller following several deaths.
The painful deaths of at least three Irish holidaymakers, and expatriates, in Spain in recent years have been linked to Nolotil, the most common brand name of the anti-inflammatory drug metamizole, which is as widely available as paracetamol.
Metamizole is an anti-inflammatory drug highly popular in Spain – each EU member state has the freedom to authorise the drug – for the treatment of mild pain, including toothaches and headaches.
It has been in use in Spain for over a hundred years and is available in some other EU countries but is banned in Ireland, the UK, US, Australia.
Public health authorities in Poland have expressed concerns about it.
Last week Spain’s medicines regulator announced an investigation into suggestions that the drug may have been the cause of several deaths, illnesses, blood poisoning and amputations over a period of up to 16 years.
Pain management consultant and member of the British Pain Society Dr Stephen Humble, told the Irish World that he is advising British and Irish people to avoid using the painkiller when abroad because the weight of evidence suggests it is too high risk.
“It is proven to be an effective drug, but medical literature alone has shown it can cause significant complications. Is it really necessary to use it anymore?” asked Dr. Humble.
One such fatal case involved the sudden death of Irishman William “Billy” Smyth, 66, from Mullingar, in 2016. He was on holiday in Torrevieja, Spain and died after he was prescribed Nolotil for shoulder pain. Smyth, a healthy man who enjoyed cycling and swimming, developed sepsis and necrotising fasciitis as a result of a low white cell count – which our bodies use to fight infection – and died.
An online petition was launched in 2016 by local expatriate news publication, The Olive Press.
It raised almost a thousand signatures calling for Nolotil to be banned. Cristina Garcia del Campo, a medical and legal translator based in Javea, Alicante, started collecting medical reports after hearing of Irish people being diagnosed with sepsis, including the case of M r Smyth.
“All the Irish there seemed to be having this problem,” she told the Irish World.
“The one thing each case had in common was Nolotil, I thought, ‘there (must) be more cases here’. And there (were), too,” she said.
She initially tried surveying her hometown, Javea, for further examples of Irish or Britons having suffered similar side effects following the use of Nolotil, specifically an online forum, Javea Connect.
After hearing nothing, Ms Garcia del Campo, 53, took her inquiries to the Costa Del Sol, a popular destination for both Irish and British tourists, and home to thousands of Irish and British expatriates.
She found upward of a hundred cases of Irish and British holidaymakers and expatriates who suffered severe side effects after taking the drug. Of ten deaths, apparently associated with Nolotil discovered by Ms Garcia Del Campo, three were of Irish men. Another Irish man fell gravely ill, said Ms Garcia Del Campo, but he eventually made a full recovery.
She presented her findings to the Spanish medicines regulatory – AEMPS – which has since ordered a full investigation.
“They listened immediately to me, which was good, and they were shocked at the scale of the problem,” she said.
In May, the European Medicines Agency’s (EMA) Committee for Human Medicinal products started a review of medicines containing metamizole. But the EMA admitted that its review, opened at the request of the Polish medicines authority, will not, as things stand, look at any of the issues Ms Garcia del Campo brought to public notice.
The EMA did say that it is aware that Spain’s AEMPS is investigating the issue, and that it is “closely following the matter to take EU-wide action, if deemed necessary”.
Nolotil is known to be associated with a risk of blood disorders, including agranulocytosis, also known as low white cell count, which proved fatal for William Smyth. The manufacturer, says Ms Garcia Del Campo, does mention the risk of agranulocytosis as a very rare but potential side-effect in its labelling. The side-effects and implications of the painkiller’s use vary from the irreversible to the benign.
“Many have had full recoveries but some have recovered not so well. I’ve had reports of people, generally, not being themselves after taking [Nolotil],” said Ms Garcia del Campo.
“Some have even had limbs amputated, which is obviously something that stays with you forever,” she says.
Those most affected appear to be predominantly Irish and British people, her investigation shows. A study in 2013 suggested that “some genetic predisposition could not be excluded, since metamizole appears to be strongly associated with agranulocytosis in certain regions of the world.”
Based on her conversations and interviews with those people most badly affected by the drug Ms Garcia del Campo found a pattern – many of the British patients who had taken the drug had either an Irish mother, father or grandparent.
Assigning blame for the deaths and, in some cases, devastating physical or mental damage, is “very complicated”, she says, as she found the Spanish medical authorities and doctors were very forthcoming and helpful at all times.
“I’ve even had people who suffered from taking the drug tell me, ‘I’m so grateful to the Spanish doctors and hospitals; I wouldn’t be alive otherwise’,” she said. “You don’t know there is a problem until there are cases. That is unfortunate, but it is just one of those terrible things that would be dealt with but nobody, nowhere, notified doctors or hospitals.”
The investigation being carried out by the Spanish medicines regulatory into Nolotil continues following Cristina’s submission, and a finding is expected in the coming weeks. The European Medicines, which has been based in London but because of Brexit says it will next year move to Amsterdam, said it would not provide a timeframe for the publication of its findings and was only prepared to say it is an “ongoing procedure”.