On an October evening last year, Summer Moses stood at her partner’s bedside in the intensive care unit of a hospital in Spain and agreed to the life support systems being turned off. Her partner, Mark Brooks, lay under a clear cover surrounded by pipes and machines. His body was swollen, blistered and broken.
Moses was in shock. Just six days earlier, Brooks had enjoyed a round of golf in eastern Spain, in bright sunshine near his home. He sought treatment for shoulder pain the next day and was given a pain-relieving injection of the drug metamizole at a local clinic.
Two days after the injection, he was admitted to hospital in the city of Torrevieja in the province of Alicante with suspected depleted white blood cells. Three days after the injection he was in intensive care with failing organs. Five days later he was dead.
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“The whole thing is a blur, like a bad dream,” says Moses, 38, who now has to raise their four-year-old daughter Aurora alone, as the sole earner. “I couldn’t believe how this could happen in less than a week. He bounced around, excited about golfing, and then he was gone.
“How could this happen? No one should die from shoulder pain from golf. It’s pointless. He had everything to live for, and we had to pick up the pieces. It’s not just Mark’s life. It is our life too.”
With the help of campaign group the Association of Drug Affected Patients (ADAF) in Spain, Moses obtained the medical notes. On the first page of the documents seen by the Observerit says: “apparent allergic reaction to metamizole”.
This is the latest death involving metamizole in Spain, where it is sold under the brand name Nolotil. One Spanish regional health department has already warned that it should not be a painkiller of choice due to the risk of adverse side effects. It is already banned in more than 30 countries, including Britain.
ADAF is taking legal action over the use of the drug in Spain and informed a British consul at the Foreign, Commonwealth and Development Office about the matter in November.
An investigation by the Observer in November there emerged concerns about the drug’s side effects. There have been more than 40 deaths in Spain where metamizole may have caused or contributed to the death, including those of many Britons. Case reports in medical journals suggest that certain populations may be more sensitive to the side effects.
Brooks, 42, a handyman and gardener who lived in Ciudad Quesada in Alicante and was originally from Chesterfield in Derbyshire, suffered a suspected reaction after being injected with metamizole at a local clinic. When he got home, a rash developed at the injection site on his left buttock, blisters began to appear on his skin, and swelling developed around his shoulder.
Moses was so concerned that she took him to the emergency department of the local hospital. The medical notes mention blistering and swelling around the buttock. “Blood tests show a tendency toward leukopenia [associated with a low white blood cell count] with signs of renal failure, in addition to liver failure.”
Brooks deteriorated rapidly. By Thursday he had fallen into a coma, and by Friday Moses was told it was only the life support systems keeping him alive. “They said it was caused by an infection and the injection was the catalyst, but no one could tell me why,” she said.
Brooks died last year on Friday, October 20. The death certificate lists multiple organ failure, septic shock and cellulitis as causes.
His death is just the latest case of a Briton in Spain where metamizole is known or suspected to have been a contributing factor. Others include:
• Mary Ward, 59, originally from Harlow, Essex, who was given Nolotil in 2001, which destroyed her white blood cells. She was on a ventilator for eight months, which damaged her throat, and suffered complications for years before dying in March 2006.
• Susan Earwaker, 62, living in Murcia, south-eastern Spain, who was given Nolotil after breaking her leg in a horse accident. She died in January 2015 from sepsis and organ failure, with an adverse reaction to the drug recorded in medical records.
• Billy Smyth, 66, a keen cyclist, who died in Spain in April 2016 from an adverse reaction to Nolotil. He died of organ failure.
• Lorna Vincent, 75, who went to hospital for intestinal surgery and was given metamizole. Her white blood cells were depleted and she died of organ failure in April 2018. The family believes drugs are involved and searches for her medical records.
Spain’s Medicines and Health Products Agency, AEMPS, says the risk of agranulocytosis from metamizole, in which white blood cells are severely depleted, is very rare, ranging from one to ten cases per million users. The benefits of the popular painkiller are said to outweigh the risks.
However, there are significant differences in these estimates. When the drug was withdrawn from the market in Sweden in 1999, regulators estimated the risk of agranulocytosis at about one in 2,000 prescriptions, with a mortality rate of 26%, and concluded that the benefit-risk profile was unfavorable.
The reasons for these variations are unclear, but some studies have suggested that certain populations may be more sensitive to side effects. A 2009 study at the Costa del Sol Hospital in Marbella concluded: “Dipyrone-related agranulocytosis is a side effect more common in [the] British population, and its use should be avoided.”
Boehringer Ingelheim, the company that makes Nolotil, says other adverse side effects, including infections, are listed on the drug information sheet. It says the current prescribing information “adequately addresses current knowledge of risks”.
“Every drug has a risk, but it’s not clear enough for people to make a decision about it,” said Derek Smyth, 49, Billy Smyth’s son. “It’s not reported enough, especially if there is a category of people who are at higher risk.”
The drug should only be available by prescription in Spain, but in November it will be Observer was able to buy two packs of Nolotil without a prescription at a pharmacy in Jávea on the Costa Blanca for less than €4. “They are handing out this drug without asking even though it is banned in many other countries,” said Graeme Ward, 81, who lost his wife Mary, who was taking the drug. “It should be forbidden.”
Vicente Palop Larrea, a doctor specializing in fibromyalgia who helped set up the Valencia region’s pharmaceutical safety authority in the 1980s, said: “Metamizole is still supplied without a prescription. It is prescribed in higher doses than recommended, without taking into account the greater susceptibility of some people to suffer from agranulocytosis.” He said he was concerned that drug side effects were under-reported.
He added: “Do not prescribe it to patients from other countries where the drug has been withdrawn from the market due to the increased risk of agranulocytosis associated with metamizole in those groups.” He said Spanish health authorities also had to think about the intramuscular injections because of the reported risks of lesions, necrosis and sepsis.
Cristina García del Campo, founder of ADAF, said a comprehensive national study was needed in Spain to determine the adverse side effects of metamizole. “Most cases of side effects from metamizole are never reported,” she said. “Until a proper investigation is done, they should withdraw the drug or only administer it under the strictest restrictions and with proper monitoring.”
The Spanish Ministry of Health and the university hospital in Torrevieja, where Mark Brooks was treated, had not responded to a request for comment at the time of publication.
Boehringer Ingelheim said: “Patient safety is our top priority, and we continually actively monitor the safety of our products and notify health authorities as new safety information becomes available.
“The side effect of agranulocytosis is addressed in the current product information. The product is only available with a medical prescription, so that treatment takes place under the supervision of a doctor.”