As Britain suffered widespread frost last week, there were blue skies, warm breezes and temperatures above 20 degrees Celsius on the white-sand beaches dotted with palm trees in Jávea on the Costa Blanca.
About 5,000 Britons live in this small town, which was once walled and fortified to protect it from marauding pirates.
People who spoke to the Observer said last week that they are enjoying the benefits of a typically efficient Spanish national healthcare system. However, there is growing concern in Jávea and other communities across the country about one of the most popular drugs: the painkiller metamizole, commonly sold in Spain as Nolotil.
Rarely, the drug, which has been discontinued in several countries, can cause a condition known as agranulocytosis, which depletes white blood cells, increasing the risk of a potentially fatal infection. A patient group, the Association of Drug Affected Patients (ADAF), says side effects have led to sepsis, organ failure and amputations.
National television and several newspapers in Spain followed suit Observer article published last weekend about a recently filed legal action by the ADAF against the Ministry of Health, demanding stricter restrictions on its use.
The newspaper El Pais reported last week that Nolotil was the best-selling branded drug in Spain in 2020, with 22.4 million units issued, citing figures from the Business Federation of Spanish Pharmacists. It reported the significant variation across scientific studies in the proportion of those experiencing serious adverse side effects and that a genetic factor may be at play.
The ADAF believes that British people are at greater risk of the side effects of the drug, but this has not been confirmed by independent scientific research. The group has identified around 350 suspected cases of agranulocytosis between 1996 and 2023, including those in 170 Britons living or holidaying in Spain.
Nolotil would only be available with a prescription, but is widely available without a prescription. The Observer was able to buy two packs of Nolotil without a prescription at a pharmacy in Jávea on Tuesday for less than €4.
Many Britons living in Spain say they would not use Nolotil due to the risk of side effects. The ADAF has produced 'No Nolotil' wristbands for patients to wear when receiving healthcare.
Hilary Sadler, 63, a graphic designer who lives in Jávea and is supporting the campaign to highlight the risk of the drug, said: “This drug has been withdrawn from the market in some countries and in others it has not been licensed at all, but the Spaniards don't seem to care. Ministry of Health. That is surprising, because there are so many alternatives.”
Bill Dunham, 80, who worked in financial services in the City of London, and his wife Rosina, 71, who lives near Jávea and is originally from Suffolk, said they would never use Nolotil. They were both wearing their 'No Nolotil' wristbands.
Rosina said the Nolotil leaflets warned about the “very rare” side effect of agranulocytosis, but she felt it was not worth the risk of a painkiller. “I don't want sepsis,” she said. “And I don't want my friends to get sepsis.”
Kay Cooper, 62, originally from Woking, Surrey, who lives in Jávea, said her husband, Steve, was given metamizole during cancer treatment even though she had suspected he was allergic to the drug and it was on his notes. He died of cancer in December 2019.
“They prescribe it for back pain, shoulder pain and toothache,” she said. “The side effects are described as very rare, but I don't find them acceptable. It's not worth risking your life for a painkiller.”
Ron Earwaker, 71, who lives in Cehegín in the Murcia region of south-east Spain and is originally from London, lost his wife Susan, 62, in 2015 after breaking her leg when she fell from her horse on New Year's Day. She was given Nolotil after surgery to fix her leg and developed agranulocytosis.
“I was told she had no white blood cells,” he said. “They were all gone. I was told it was very serious.”
Susan died on January 18, 2015 from sepsis and multi-organ failure, which can develop due to agranulocytosis. The medical records seen by the Observer stated that the condition was likely a drug reaction and noted that she had been given Nolotil.
Earwaker said he was in shock because his wife had deteriorated so quickly. He said he was stunned to discover that an adverse reaction to a painkiller was the suspected cause. “You can walk into almost any pharmacy and just buy this,” he said. “It should be forbidden. There is no other option.”
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The year after Susan's death, Irish holidaymaker William Smyth, 66, died of multi-organ failure after being prescribed Nolotil for shoulder pain. His white blood cells were significantly depleted before he fell into a coma. The Observer Last week the case of Paddy Clancy, 80, a British expat who developed agranulocytosis after being given metamizole following shoulder surgery, was reported. He was in a coma for 39 days, but gradually recovered.
On a sunny Wednesday afternoon on Jávea's Arenal promenade, several British residents enjoyed a stroll or relaxed in the seafront restaurants and bars. Some had never heard of Nolotil, but others were alert to the risks.
Carol Hermitage, 69, who has lived in Jávea for more than 20 years, said she found the healthcare in Spain “fantastic” but said there were warnings on Facebook groups in the British community about metamizole. She said: “They say if you're in hospital make sure you don't get Nolotil.”
Despite the controversy, medical experts told Spanish media last week that the drug's package leaflet warned about the rare risk of side effects. The guideline is that metamizole should generally only be used for short-term treatments and that regular blood tests should be carried out for long-term use.
Cristina García del Campo, founder of ADAF, said that as a result of the publicity, new cases have emerged with adverse side effects. She said she welcomed new restrictions introduced in October 2018 on the use of the drug, but these were not well enforced.
She said: “It has been proven that they do not have proper control over it, and it should be withdrawn, just like in other countries.” She said many doctors were still not recognizing the conditions of agranulocytosis associated with metamizole, and the potentially fatal side effects were likely to be significantly underreported.
Data from the Spanish Medicines and Health Products Agency, AEMPS, reports 457 cases of agranulocytosis associated with metamizole between 1990 and 2023.
Boehringer Ingelheim, the company that makes Nolotil, says it is a prescription drug with an established and known safety profile. It says that agranulocytosis is a very rare side effect and is described in the package leaflet.
The Spanish Ministry of Health said it had carried out an investigation in 2018 after becoming aware of cases of agranulocytosis, mainly in patients of British descent. It said a greater risk in certain populations could not be confirmed, but new guidelines were introduced in 2018 to reduce the risk, including the recommendation not to use the drug in 'floating populations' that could not be monitored.
It said an epidemiological study had also been commissioned and although this has not yet been published, it found that the magnitude of the risk is within currently known and managed levels. It was stated that agranulocytosis was a known side effect of metamizole and reports of these reactions were collected and publicly available.