On an October evening last year, Summer Moses went to her partner’s bed in the intensive care unit of a hospital Spain and agreed that the life support systems could be turned 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 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 an analgesic injection of the drug metamizole at a local clinic.
Two days after the injection, he was admitted to the hospital in the town of Torrevieja in the Alicante province with presumably depleted white blood cells. Three days after the stabbing, he was in intensive care with failing organs. Five days later he was dead.
“The whole thing is a blur, like a bad dream,” says Moses (38), who is now left to raise their four-year-old daughter, Aurora, on her own as the sole breadwinner. “I couldn’t believe how this happened in less than a week. He bounced around, excited about the golf, and then he was gone.
“How could this have happened? No one should die after a shoulder pain from golf. It’s pointless. He had everything to live for, and we were left to pick up the pieces. It’s not just Mark’s life. These are our lives too.”
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 Observerit says: “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 pain reliever because of the risk of adverse side effects. It has already been 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 of the Foreign, Commonwealth and Development Office about the matter in November.
An investigated by the Observer in November revealed concerns about adverse reactions to the drug. There have been more than 40 deaths in Spain in which metamizole caused or contributed to death, including those of many Britons. Case reports in medical journals suggest that certain populations are 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 had developed at the injection site on his left buttock, his skin had started to blister and there was swelling around his shoulder.
Moses was so worried that she took him to the accident and emergency unit of the local hospital. The medical notes record blisters and swelling around the buttocks. “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 deteriorated rapidly. By Thursday he had slipped into a coma, and on Friday Moses was told that only the life support systems were keeping him alive. “They said it was caused by an infection and the injection was the catalyst, but nobody 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 contributing factor. Others include:
Mary Ward, 59, originally from Harlow, Essex, who was given Nolotil in 2001, had her white blood cells wiped out. She was on a ventilator for eight months and destroyed her throat and suffered 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 of sepsis and organ failure in January 2015, with medical files recording an adverse reaction to the drug.
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 bowel surgery and was given metamizole. Her white cells were depleted and she died of organ failure in April 2018. The family believes the drug was involved and is looking for her medical records.
Spain’s Agency for Medicines and Health Products, 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 pain reliever outweigh the risks.
However, there are significant variations in these estimates. When the drug was withdrawn in Sweden in 1999, regulators estimated the risk of agranulocytosis at about one in 2,000 prescriptions, with a mortality rate of 26%, concluding that the benefit-risk profile was unfavorable.
The reasons for these variations are unclear, but some research has suggested that certain populations are more susceptible to adverse reactions. A 2009 study at the Costa del Sol Hospital in Marbella concluded: “Dipyrone-related agranulocytosis is an adverse effect that occurs more frequently 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 about risks”.
“Every drug has a risk, but it’s not clear enough for people to make a decision about it,” said Derek Smyth, 49, the son of Billy Smyth. “There is not enough reporting on it, especially when there is a category of people who are at greater risk.”
The drug should only be available in Spain by prescription, but in November the Observer was able to buy two packs of Nolotil from a pharmacy in Jávea on the Costa Blanca for less than €4, without a prescription. “They hand out this drug without any questions, even though it’s 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 specializing in fibromyalgia who helped set up the Valencia region’s pharmaceutical safety authority in the 1980s, said: “Metamizole is still being issued 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 underreported.
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 should also think about the intramuscular injections because of the reported risks of scarring, necrosis and sepsis.
Cristina García del Campo, founder of ADAF, said there should be a comprehensive national study in Spain to determine 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 administer it only 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 yet responded to a request for comment by the time of publication.
Boehringer Ingelheim said: “Patient safety is our top priority, and we 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 only available on medical prescription so that therapy is under the supervision of a physician.”
