One October evening last year, Summer Moses stood by her partner’s bedside in the intensive care unit of a hospital in Spain and acknowledged that life support systems might be turned off. Her partner, Mark Brooks, lay under a clear sheet surrounded by tubes and machines. His body was swollen, blistered and broken.
Moses was in shock. Just six days ago, Brooks was enjoying a round of golf in bright sunshine near his home in eastern Spain. The next day, he sought treatment for shoulder pain and was given a pain-relieving injection of the drug metamizole at a local clinic.
Two days after the injection, he was hospitalized in the town of Torrevieja, in the province of Alicante, with suspected depletion of his white blood cells. Three days after the injection, he was in intensive care because his organs were failing. He died five days after that.
Relating to: ‘They thought I had cancer’: Painkiller banned in UK linked to British deaths in Spain
“Everything is blurry, like a bad dream,” said Moses, 38, who now has to raise their four-year-old daughter Aurora on her own. “I couldn’t believe how this happened in less than a week. He was excited to play golf and then he left.
“How could this have happened? No one should die from shoulder pain from golf. This is so pointless. He had everything to live for and we had to pick up the pieces. This isn’t just Mark’s life. “This is also our life.”
Musa obtained the medical notes with the help of the campaign group Association of Drug-Affected Patients (ADAF) in Spain. On the first page of the documents I saw Observerstates: “marked allergic reaction to metamizole”.
The incident was the latest death to occur in Spain, where metamizole is sold under the brand name Nolotil. A Spanish regional health department has warned that it should not be the first choice painkiller due to the risk of negative side effects. It is already banned in more than 30 countries, including the UK.
ADAF is taking legal action over the use of the drug in Spain and notified a British consul from the Foreign, Commonwealth and Development Office about the incident in November.
An investigation by Observer Concerns about adverse reactions to the drug emerged in November. More than 40 deaths occurred in Spain in which metamizole may have caused or contributed to the death; This includes many Britons. Case reports in medical journals suggest that certain populations may be more sensitive to side effects.
Brooks, a 42-year-old mechanic and gardener from Ciudad Quesada in Alicante and originally from Chesterfield in Derbyshire, suffered a suspicious reaction after receiving an injection of metamizole at a local clinic. When he came home, a rash appeared at the injection site on his left hip, his skin began to blister, and swelling occurred around his shoulders.
Moses became so worried that he took her to the local hospital’s accident and emergency department. Medical notes state blistering and swelling in the hip area. “Blood tests show a tendency to leukopenia [associated with a low white blood cell count] “In addition to liver failure, there are also symptoms of kidney failure.”
Brooks deteriorated rapidly. He fell into a coma on Thursday, and on Friday Musa was told it was only his life support systems that were keeping him alive. “They said it was due to an infection and the injection was the catalyst, but no one could tell me why,” he said.
Brooks passed away on Friday, October 20 last year. The death certificate states the causes were multiple organ failure, septic shock and cellulitis.
His death is the latest case of a Briton in Spain where metamizole is known or suspected to be a contributing factor. Others include:
• Mary Ward, 59, originally from Harlow, Essex, was administered Nolotil, which destroys white blood cells, in 2001. She was on a ventilator for eight months, suffered a damaged throat and suffered from complications for years before dying in March 2006.
• Susan Earwaker, 62, of Murcia in southeastern Spain, was prescribed Nolotil after breaking her leg in a horse accident. She died of sepsis and organ failure in January 2015, due to medical files recording an adverse reaction to the drug.
• Billy Smyth, a 66-year-old passionate cyclist, died in Spain in April 2016 due to a negative reaction to Nolotil. He died of organ failure.
• Lorna Vincent, 75, who went to hospital for bowel surgery and was given metamizole. His white cells were depleted and he died of organ failure in April 2018. The family believes the drug was involved and is seeking the woman’s medical records.
Spain’s medicines and healthcare products agency AEMPS says the risk of agranulocytosis from metamizole, a severe depletion of white blood cells, is very rare, in the range of 1 to 10 cases per million users. It is stated that the benefits of the popular painkiller outweigh its risks.
However, there are significant differences in these estimates. When the drug was withdrawn in Sweden in 1999, regulators concluded that the benefit-risk profile was unfavorable, estimating the risk of agranulocytosis at approximately 1 in every 2000 prescriptions and the mortality rate at 26%.
The reasons for these changes are unclear, but some research suggests that certain populations may be more susceptible to adverse reactions. A 2009 study at the Costa del Sol hospital in Marbella concluded: “Dipyrone-associated agranulocytosis is a side effect more common in women. [the] British population and use should be avoided.”
Boehringer Ingelheim, the company that makes Nolotil, says other negative side effects, including infections, are listed on its drug information page. It says current prescribing information “adequately addresses existing information about risks.”
“Every drug has a risk, but it’s not clear enough for people to make a decision on that,” said Derek Smyth, 49, son of Billy Smyth. “There hasn’t been adequate reporting on that, especially if there’s a category that’s at higher risk.”
The drug will be available in Spain by prescription only, but in November Observer He was able to buy two packs of Nolotil without a prescription from a pharmacy in Jávea on the Costa Blanca for less than 4 euros. Graeme Ward, 81, who lost his wife Mary, who took the drug, said: “They distribute this drug without asking any questions, even though it is banned in many countries.” “It should be banned.”
Vicente Palop Larrea, a doctor specializing in fibromyalgia who helped establish the Valencia region’s pharmaceutical safety authority in the 1980s, said: “Metamizole continues to be distributed without a prescription. “It is prescribed in higher doses than recommended, regardless of the fact that some people are more prone to agranulocytosis.” He said he was concerned about under-reporting of adverse drug reactions.
It added: “Do not prescribe this medicine to patients in other countries where the medicine has been withdrawn due to the increased risk of metamizole-associated agranulocytosis in these groups.” He said Spanish health authorities should also consider intramuscular injections due to the reported risks of lesions, necrosis and sepsis.
ADAF founder Cristina García del Campo said a comprehensive national study should be conducted in Spain to determine the negative side effects of metamizole. “Most adverse drug reactions from metamizole have never been reported,” she said. “They should withdraw the drug or administer it only under the strictest restrictions and appropriate monitoring until an appropriate study has been conducted.”
The Spanish Ministry of Health and the university hospital in Torrevieja, where Mark Brooks was treated, did not respond to a request for comment at the time the news was published.
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 when new safety information becomes available.
“The side effect of agranulocytosis is covered in the available product information. The product is available only by medical prescription, so the therapy is carried out under the supervision of a physician.”