As Britain faced widespread frosts last week, there were blue skies, a warm breeze and temperatures above 20C on white sand beaches dotted with palm trees in Jávea on the Costa Blanca.
About 5,000 Britons live in this small town, once walled and fortified to protect it from marauding pirates.
People who spoke to the Observer last week say they enjoy the benefits of a typically efficient Spanish national health service. However, there is increasing concern in Jávea and other communities across the country about one of its most popular drugs: the painkiller metamizole, commonly sold in Spain as Nolotil.
In rare cases the drug, withdrawn in several countries, can cause a condition known as agranulocytosis, which depletes white blood cells, increasing the risk of potentially fatal infection. A patients group, the Association of Drug Affected Patients (ADAF), says adverse reactions have led to sepsis, organ failure and amputations.
National TV and several newspapers in Spain followed up an Observer article published last weekend on a recently filed legal action by the ADAF against the ministry of health, demanding tighter restrictions on its use.
The newspaper El País reported last week that in 2020 Nolotil was the bestselling brand medicine in Spain, with 22.4m units dispensed, citing figures from the Business Federation of Spanish Pharmacists. It reported the significant variation in scientific studies in the proportion of those who suffered severe adverse side effects and that a genetic factor may be involved.
The ADAF believes British people are more at risk from the drug’s side effects, but this has not been confirmed by independent scientific study. The group has identified about 350 suspected cases of agranulocytosis between 1996 and 2023, including those of 170 Britons who live in Spain or were on holiday.
Nolotil is supposed to be prescription only but is widely available over the counter. The Observer was able to purchase two packets of Nolotil on Tuesday at a chemist’s in Jávea for less than €4, without a prescription.
Many Britons who live in Spain say they would not take Nolotil because of 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a graphic designer who lives in Jávea and supports the campaign to highlight the drug’s risk, said: “This drug has been withdrawn in some countries and never licensed at all in others, but it does not seem to concern the Spanish health ministry. It’s 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 live near Jávea and are originally from Suffolk, said they would never take Nolotil. They were both wearing their “No Nolotil” wristbands.
Rosina said the Nolotil leaflets warned of the “very rare” side effect from agranulocytosis, but she considered it was not worth the risk for a painkiller. “I don’t want sepsis,” she said. “And I don’t want my friends to have sepsis.”
Kay Cooper, 62, originally from Woking, Surrey, who lives in Jávea, said her husband, Steve, was given metamizole during treatment for cancer, even though she had suspected he was allergic to the drug and it was written on his case notes. He died from cancer in December 2019.
“They prescribe it for back pain, shoulder pain, toothache,” she said. “The side effects are described as very rare, but I don’t consider them acceptable. It’s not worth putting your life at risk for a painkiller.”
Ron Earwaker, 71, who lives in Cehegín in the region of Murcia in south-east Spain and is originally from London, lost his wife Susan, 62, in 2015 after she broke her leg falling from her horse on New Year’s Day. She was given Nolotil following an operation to fix her leg and developed agranulocytosis.
“I was told she had no white blood cells,” he said. “They had all gone. I was told it was very serious.”
Susan died on 18 January 2015 of sepsis and multi-organ failure, which can develop as a result of agranulocytosis. The medical records seen by the Observer state the condition was probably a drug reaction and noted she had been given Nolotil.
Earwaker said he was in a state of shock that his wife had deteriorated so rapidly. He said he was stunned when he discovered an adverse reaction to a painkiller was the suspected cause. “You can walk into virtually any chemist and just buy this,” he said. “It should be banned. There is no other option.”
The year after Susan’s death, Irish holidaymaker William Smyth, 66, died from multi-organ failure after being prescribed Nolotil for shoulder pain. His white cells were significantly depleted before he fell into a coma. The Observer last week reported the case of Paddy Clancy, 80, a British expatriate who developed agranulocytosis after being given metamizole following a shoulder operation. He was in a coma for 39 days but gradually recovered.
On a sunny Wednesday afternoon on the Arenal promenade in Jávea, several British residents were enjoying a stroll or relaxing in the seafront restaurants and bars. Some had not heard of Nolotil, but others were alert to the risks.
Carol Hermitage, 69, who has lived in Jávea for more than two decades, said she considered the healthcare in Spain to be “fabulous” but said there were alerts on Facebook groups in the British community about metamizole. She said: “They say if you are in hospital, make sure you are not given Nolotil.”
Despite the controversy, medical experts in the Spanish media said last week the rare risk of side effects was warned about in the information leaflet for the drug. The guidance is that metamizole should typically only be used for short-term treatments and that regular blood tests should be conducted for any longer-term use.
Cristina García del Campo, founder of ADAF, said new cases had come forward involving adverse side effects as a result of the publicity. She said she welcomed new restrictions that were introduced for the use of the drug in October 2018, but they were not properly followed.
She said: “It has been proved they cannot control it properly, and it should be withdrawn like it has in other countries.” She said many doctors still did not recognise the conditions of agranulocytosis associated with metamizole, and the potentially fatal side effects were likely to be significantly underreported.
Data from Spain’s medicine and health products agency, the 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 well-known safety profile. It says agranulocytosis is a very rare adverse reaction and is described in the drug information leaflet.
The Spanish health ministry said it had conducted a review in 2018 after it was notified about cases of agranulocytosis, particularly in patients of British origin. 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 was also commissioned and while it has not yet been published it indicated the magnitude of risk is within currently known and managed levels. It said agranulocytosis was a known adverse reaction to metamizole and that reports of these reactions were collected and publicly available.
