HEALTH WARNING OVER METAMIZOLE DANGERS
Side effects of painkiller highlighted
DOCTORS and medical teams have been issued with strict guidelines about the use of the painkiller metamizole because of the risk of ‘horrific’ and potentially fatal side effects.
The Spanish medications and sanitary products agency (AEMPS) issued the information for ‘health professionals’ on Wednesday after weeks of research – reminding them that medicines containing the analgesic were prescription only drugs.
And Madrid-based AEMPS ordered all adverse reactions to the drug must be reported.
Cristina García del Campo, a medical translator who started her own investigation into the effects of metamizole after a client died last December, said she was ‘happy’ with the agency warning, ‘which will save lives’.
Metamizole is a generic name; there are a number of brand names including Nolotil, Metamizol, Algi-mabo, Buscapina Compositum and Metalgial.
High risk groups – including British people and northern Europeans – have developed agranulocytosis, a sudden and dangerous drop in disease-fighting white blood cells, leaving patients open to infection.
People have suffered sepsis and developed septic shock – victims have developed gangrene and suffered life-changing conditions.
Guidance
The AEMPS issued the following guidance to medical teams across Spain:
■ To be sold only on prescription
■ Before prescribing it, to conduct a detailed analysis of each patient’s medical history to avoid administering it to those at risk
■ To be prescribed only for short term treatment and in minimal doses, watching out for any signs or symptoms suggestive of agranulocytosis
■ In cases where longer treatment is necessary, regular blood tests must be carried out, including a white blood cell count
■ To inform patients they must stop treatment immediately should they experience any signs or symptoms suggestive of agranulocytosis
■ Not to administer or prescribe metamizole to those patients who cannot be closely monitored (for example the floating population)
In its statement, the AEMPS said metamizole is an analgesic and antipyretic (used to reduce a fever) which has been marketed for more than 50 years in Spain under different trade names and is ‘widely used’.
The body said possible adverse reactions such as agranulocytosis and neutropenia are known. “Although of very low frequency, it is a serious reaction that can lead to the death of a patient... it is considered an immunological type reaction.”
Under-reporting
The AEMPS reviewed the situation because of recent notifications of the side effects ‘particularly in patients of British origin’.
And the report said: “The information of the cases reported in Spain indicates their number has increased in recent years in parallel with the increase in consumption of this analgesic.
“However, the available data does not allow the calculation of the incidence of occurrence and it is likely there is a significant under-reporting as it is a known adverse reaction. The data also confirms the increased risk in elderly patients, something already known.
“Although this adverse reaction may occur at any time during the treatment, in more than half of the notified cases in which information is available, it was greater than one week”.
The agency said the use of metamizole in Spain, based on health service records, had doubled in the last 10 years – the most marked jump in the drug being dispensed over the last five years. Between 2013 and 2017, it rose from 14.6 million tablets to 22.8 million.
The health body said the data also showed the increase in metamizole being prescribed to elderly patients.
However, the AEMPS noted there was discussion for many years about a ‘greater susceptibility’ to agranulocytosis in the north-European population. “Certain genetic factors have been studied, with the available information, it is not possible to discard or confirm an increased risk in populations with ethnic characteristics.”
Cristina García del Campo, who lives in Jávea, said her research of the effects of the drug would continue; recent cases discovered across Spain have also shown an allergic reaction in the Spanish population.
She underlined she had found cases where people developed complications after taking ‘one or two’ pills, ‘although most were after the first week’, which is what they have said.
Evidence
Cristina twice gave evidence before experts at the AEMPS and was thanked for her research data she submitted.
She said she never believed the painkiller would be banned because of a lack of alternatives. “They have done a lot, for example saying it cannot be sold without a prescription; it is a start.
“They also insist that doctors take a full medical history before prescribing it and must monitor the patient.”
She said the warning about the use of metamizole with the ‘floating population’ should also protect visitors and holiday-Campaigner makers arriving in Spain.
“All in all I am happy; they could have done a lot less but I think the problem with British patients should stand out much more – I am very glad they listened to me, to someone from outside the medical world; they listened to what I had to say and took notice.
“Because it was always seen as a safe drug, a lot of people, especially doctors, would not listen when people said they were worried – they just laughed. I can now give this advice to people to take it to doctors with them, it makes it so much more powerful.
“All in all I am very happy with the AEMPS response and the information they are giving to medical professionals”.