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Many people are becoming increasingly concerned about the painkiller Nolotil after a British citizen's death in Spain was reported as being "like a bad dream."

Many people are becoming increasingly concerned about the painkiller Nolotil after a British citizen’s death in Spain was reported as being “like a bad dream.”

Last October, Summer Moses was present at her partner’s bedside in a Spanish hospital’s intensive care unit. She gave consent for the life support systems to be turned off. Mark Brooks, her partner, was lying under a see-through covering with tubes and machines around him. His body was swollen, blistered, and injured.

Moses was completely shocked. Only six days prior, Brooks was happily playing golf in eastern Spain under the sunny skies near his house. However, the next day he had to seek medical assistance for shoulder pain and received a pain-relieving injection of metamizole at a nearby clinic.

Two days following the administration of the injection, he was hospitalized in the city of Torrevieja in the province of Alicante due to a potential decrease in his white blood cell count. Three days after receiving the shot, he was transferred to the intensive care unit as his organs began to fail. Five days after the injection, he passed away.

Moses, age 38, shared that the entire situation feels like a hazy nightmare. She is now responsible for their four-year-old daughter, Aurora, as the only source of income. “I was in disbelief how everything changed in just one week. He was full of energy and looking forward to his golf game, and then he was suddenly gone.”

“How could this have occurred? It’s unfathomable that someone would die from a shoulder pain caused by playing golf. It’s a tragedy. He had so much to live for, and now we’re left to deal with the aftermath. This affects not only Mark’s life, but ours as well.”

Moses was able to obtain medical records with the assistance of the Association of Drug Affected Patients (ADAF) in Spain. The initial page of the papers, which were reviewed by the Observer, indicates a “seemingly allergic response to metamizole.”

The most recent fatality related to metamizole has occurred in Spain, where it is marketed as Nolotil. A health department in one Spanish region has cautioned against using it as a primary pain reliever due to the possibility of negative reactions. It has been prohibited in over 30 countries, including the United Kingdom.

ADAF has initiated legal proceedings against the usage of the medication in Spain and provided a briefing to a British consul from the Foreign, Commonwealth and Development Office regarding the matter in November.

In November, the Observer conducted a study that expressed worries about negative responses to the medication. In Spain, there have been over 40 fatalities potentially linked to or caused by metamizole, including several individuals from Britain. Medical publications have published case studies indicating that certain groups may be more vulnerable to experiencing adverse effects.

At the age of 42, Brooks, a skilled worker and cultivator residing in Ciudad Quesada, Alicante, but hailing from Chesterfield, Derbyshire, experienced a potential reaction following an injection of metamizole at a nearby clinic. Upon returning home, he developed a rash at the injection site on his left buttock, his skin began to blister, and there was pronounced swelling around his shoulder.

Moses was extremely concerned, so he brought him to the nearest hospital’s emergency department. The medical records noted blistering and swelling in the buttock region. “Blood tests revealed a propensity for leukopenia [characterized by a low white blood cell count] and indications of kidney and liver failure.”

Brooks’ condition worsened quickly. By Thursday, he had fallen into a coma, and on Friday, Moses was informed that the life support machines were the only thing keeping him alive. “They explained that an infection was the cause and that the injection was the trigger, but they couldn’t give me any further details,” she stated.

On October 20th of last year, Brooks passed away. The official cause of death, as stated on the death certificate, was a combination of organ failure, septic shock, and cellulitis.

The recent passing of this individual is another instance in which British and Irish individuals in Spain have been linked to metamizole as a potential contributing factor. Additional cases include:

Mary Ward, a 59-year-old woman from Harlow, Essex, received Nolotil in 2001 which caused a depletion of her white blood cells. As a result, she spent eight months on a ventilator and experienced damage to her throat. She continued to face complications for several years until her passing in March 2006.

Susan Earwaker, a 62-year-old resident of Murcia, Spain, received Nolotil for a broken leg sustained in a horse riding incident. She passed away in January 2015 due to sepsis and organ failure, as her medical records noted an adverse reaction to the medication.

Billy Smyth, a 66-year-old avid cyclist from Mullingar, Ireland, passed away in April 2016 while in Spain due to a negative response to Nolotil. He ultimately succumbed to 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.

The AEMPS, which is Spain’s agency for medicine and health products, states that the likelihood of developing agranulocytosis (a condition where there is a severe decrease in white blood cells) from using metamizole is extremely low, with only one to 10 cases per million users. They believe that the advantages of this widely used pain reliever outweigh the potential risk.

However, there are notable discrepancies in these calculations. After the medication was discontinued in Sweden in 1999, regulators approximated that the likelihood of agranulocytosis was approximately one in every 2,000 prescriptions, and the mortality rate was 26%. As a result, they determined that the balance between benefits and risks was unfavorable.

Susan Earwaker, who lived in Murcia, was given Nolotil after breaking her leg in a horse accident and later died of sepsis.

The causes for these differences are not fully understood, however, some studies have indicated that certain groups may be more prone to negative reactions. A research done in 2009 at Costa del Sol Hospital in Marbella stated: “Agranulocytosis caused by Dipyrone is more common among the British population and its usage should be avoided.”

According to the manufacturer of Nolotil, Boehringer Ingelheim, the drug information sheet contains warnings about various negative effects, such as infections. The company claims that the current prescribing information sufficiently covers the known risks.

Derek Smyth, age 49 and son of Billy Smyth, expressed that all medications carry a certain level of risk. However, the information available to the public is not comprehensive enough to make informed decisions about their usage. He also highlighted the lack of thorough research, particularly for those who may be more susceptible to these risks.

In Spain, the medication Nolotil should only be obtained with a prescription. However, in November, the Observer was able to purchase two packages of Nolotil from a pharmacy in Jávea on the Costa Blanca for less than €4, without a prescription. According to Graeme Ward, 81, whose wife Mary passed away after taking the drug, it is concerning that this medication is readily available without any inquiries, despite being banned in several other countries. He believes it should be prohibited.

Doctor Vicente Palop Larrea, an expert in fibromyalgia who played a role in establishing the Valencia region’s pharmaceutical safety authority in the 1980s, expressed his opinion on the continued dispensing of Metamizole without a prescription. He noted that it is often prescribed in higher doses than recommended, disregarding the fact that some individuals are more prone to developing agranulocytosis. He also raised concerns about the under-reporting of adverse drug reactions.

He stated, “Please do not recommend this medication to patients from countries where it has been banned due to the higher likelihood of agranulocytosis linked to metamizole in those populations.” He also urged Spanish health officials to consider the potential risks of intramuscular injections, including lesions, necrosis, and sepsis.

According to Cristina García del Campo, the creator of ADAF, it is necessary to conduct a thorough investigation in Spain to determine the negative effects of metamizole. She stated that the majority of adverse reactions to this drug are not documented. She believes that until a proper study is conducted, the drug should be removed from use or only given with strict limitations and careful supervision.

As of the time of publishing, there has been no response from the Spanish Ministry of Health or the University Hospital of Torrevieja, where Mark Brooks received treatment.

Boehringer Ingelheim stated that their main concern is the safety of their patients, and they continuously monitor the safety of their products. If any new safety information arises, they promptly inform health authorities.

The potential consequences of agranulocytosis are discussed in the current product information. The product can only be obtained with a medical prescription to ensure that treatment is overseen by a doctor.

Source: theguardian.com