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 the life support systems could be switched off. Her partner, Mark Brooks, lay under a transparent cover surrounded by tubes and machines. His body was swollen, blistered and broken.
Moses was in a state of shock. Just six days earlier, Brooks had been enjoying a game of golf in eastern Spain in bright sunshine near his home. He sought treatment the next day for shoulder pain, and was given a painkiller injection of the drug metamizole at a local clinic.
Two days after the injection, he was admitted to hospital in the town of Torrevieja in Alicante province with suspected depleted white blood cells. Three days after the jab, he was in intensive care with failing organs. Five days after it, he was dead.
“The whole thing is a blur, like a bad dream,” said Moses, 38, who is now left to raise their four-year-old daughter, Aurora, on her own as the sole earner. “I couldn’t believe how this happened in less than a week. He was bouncing around, excited about the golf, and then he’s gone.
“How could this have happened? No one should be dying after a shoulder pain from golf. It’s senseless. He had everything to live for, and we’ve been left to pick up the pieces. It’s not just Mark’s life. It is our lives as well.”
With the help of the 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 Observer, it states: “apparent allergic reaction to metamizole”.
The case 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 first-choice painkiller, because of 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 briefed a British consul from the Foreign, Commonwealth and Development Office on the case in November.
An investigation by the Observer in November revealed concerns over adverse reactions to the drug. There have been more than 40 deaths in Spain in which metamizole may have led to or contributed to death, including those of many Britons. Case reports in medical journals suggest certain populations may be more susceptible 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 the metamizole injection at a local clinic. When he got home, a rash developed at the injection site on his left buttock, his skin was starting to blister and there was swelling around his shoulder.
Moses was so worried she took him to the accident and emergency unit of the local hospital. The medical notes record blistering and swelling around the buttock area. “Blood tests show a tendency towards leukopenia [associated with a low white blood cell count] with signs of kidney failure, in addition to liver failure.”
Brooks rapidly deteriorated. By Thursday, he had slipped into a coma, and on Friday, Moses was told it was only the life support systems that were 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 on Friday 20 October last year. The death certificate records the causes as multiple organ failure, septic shock and cellulitis.
His death is just the latest case of a Briton in Spain where metamizole is known or suspected to have been a contributory factor. Others include:
Mary Ward, 59, originally from Harlow, Essex, who was administered Nolotil in 2001, wiping out her white blood cells. She was on a ventilator for eight months, destroying her throat, and suffered from complications for years before dying in March 2006.
Susan Earwaker, 62, who lived in Murcia, south-east Spain, who was given Nolotil after breaking her leg in a horse accident. She died in January 2015 of sepsis and organ failure, with medical files recording an adverse reaction to the drug.
Billy Smyth, 66, a keen cyclist, who died in Spain from an adverse reaction to Nolotil in April 2016. He died of organ failure.
Lorna Vincent, 75, who went to hospital for a bowel operation and was given metamizole. Her white cells were depleted and she died in April 2018 of organ failure. The family believes the drug was involved and is seeking her medical records.
Spain’s medicine and health products agency, the AEMPS, says the risk of agranulocytosis from metamizole, in which white blood cells are severely depleted, is very rare, in the range of one to 10 cases per million users. It says the benefits of the popular painkiller outweigh the risk.
There are, however, significant variations in these estimates. When the drug was withdrawn in Sweden in 1999, regulators estimated the risk of agranulocytosis at about one in every 2,000 prescriptions, with a mortality rate of 26%, concluding that the benefit-risk profile was unfavourable.
The reasons for these variations are unclear, but some research has suggested certain populations may be more susceptible to adverse reactions. A 2009 study at the Costa del Sol hospital in Marbella concluded: “Dipyrone-related agranulocytosis is an adverse effect more frequent in [the] British population, and its use must 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 about risks”.
“Every drug has a risk, but it’s not clear enough for people to make a decision on it,” said Derek Smyth, 49, the son of Billy Smyth. “There has not been enough reporting done on it, especially if there is a category of people who are at higher risk.”
The drug should only be available in Spain on prescription, but in November the Observer was able to buy two packets of Nolotil at a chemist in Jávea on the Costa Blanca for less than €4, without a prescription. “They hand this drug out without any questions even though it is banned in many other countries,” said Graeme Ward, 81, who lost his wife, Mary, who took the drug. “It should be banned.”
Vicente Palop Larrea, a doctor specialising in fibromyalgia who helped set up the Valencia region’s pharmaceutical safety authority in the 1980s, said: “Metamizole continues to be dispensed without a prescription. It is prescribed in doses higher than those recommended, without taking into account the greater susceptibility of some people to suffer from agranulocytosis.” He said he was concerned that adverse drug reactions were under-reported.
He added: “Do not prescribe it to patients from other countries where the drug has been withdrawn because of the increased risk of agranulocytosis associated with metamizole in those groups.” He said the Spanish health authorities also needed to think about the intramuscular injections because of the reported risks of lesions, necrosis and sepsis.
Cristina García del Campo, founder of ADAF, said there needed to be a comprehensive national study in Spain to establish the adverse side-effects of metamizole. “Most of the cases of adverse drug reactions from metamizole are never reported,” she said. “Until a proper study is done, they should withdraw the drug or only administer it under the tightest 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 by the time of publication.
Boehringer Ingelheim said: “Patient safety is our top priority, and we actively monitor the safety of our products on an ongoing basis and notify health authorities if new safety information becomes available.
“The side-effect of agranulocytosis is addressed in the current product information. The product is available on medical prescription only so that therapy is under supervision of a physician.”