Is it safe to take Nolotil, a drug banned in the UK and USA?

Nolotil has been in the spotlight these past few weeks. A lawsuit taken out by a patients group against the Spanish government for permitting its continued use has opened the debate on whether the active ingredient of this drug, metamizole, is safe. The case is as follows: according to the Association of People Affected by Drugs (ADAF), the plaintiff, doctors here prescribe this painkiller ad nauseam, even to British tourists. The heart of the matter is that, in recent years, 45 of them have allegedly died of complications from taking this drug. Furthermore, another 125 have suffered adverse side effects. In all cases, it would seem, they had been prescribed this medication during a holiday or a longer stay here, blissfully unaware of the UK ban on Nolotil.

So, with this case out in the open, many people have begun to question if Nolotil really is a safe drug. This painkiller is one of the most popular pills to pop in Spain (22 million boxes sold in 2020). Apart from being prescribed to relieve severe pain, it is also used as "an antipyretic [to reduce fever], but only in cases where the fever has not responded to other medication or in people with certain allergies," says Juan del Arco, president of the Pharmacy section of the Bilbao Academy of Medical Sciences.

Nolotil has been in use in Spain for over 50 years and to date there have been no data to suggest we should distrust it. "Of course it has side effects, like all drugs. paracetamol has side effects too," says Del Arco. He recommends we should not overreact: if we use it well there should be no problem.

"Firstly, it cannot be dispensed without a doctor's prescription. Secondly, the packet's Instructions for Use leaflet states two important things: it should not be used to treat pain in the long-term and, once finished, there should be a follow-up with the patient."

This means that a doctor can prescribe Nolotil for seven days without question. Should more time be required, then tests must be run on the patient, including a blood test to ascertain if the metamizole agent is harming them.

In the case of the British patients who took Nolotil, most of them succumbed to a disease called agranulocytosis, a severe and acute form of neutropenia. In layman's terms, this means a sudden drop in the white blood cell count, leaving the affected individual more prone to infection.

"This is an exceedingly rare adverse reaction to this medication with less than one case per 10,000 patients treated," says José Manuel Paredero, president of the Spanish Society of Primary Care Pharmacists (SEFAP). Del Arco adds that the incidence rate for this complication is even lower here in Spain.

Paredero also stresses the fact that the risks in taking this drug have not changed at all. The Spanish Agency for Medicines and Medical Devices (AEMPS), a governmental agency, has declared that "There are no new findings". Back in 2018 this agency had already published a cautionary note on this topic for health professionals, recommending that "they do not prescribe metamizole to patients when it is impossible to monitor them, for example, with people who come and go from the area."

So, follow-ups are essential when metamizole is part of a prolonged treatment. The prescribing doctor should be monitoring the patient. Why? Largely because the symptoms of agranulocytosis are "non-specific", explains Del Arco: feeling generally unwell, infections, sores, bruising, pale complexion, bleeding. You should also accept that having any of these symptoms does not necessarily mean that you have that specific complication.

So, if metamizole is safe, the next question - the one sparking all the controversy - is: why has it been banned in the United Kingdom? Our two experts are in agreement that this is because it is "epidemiological". In Spain cases of agranulocytosis are few and far between whereas they occur more frequently there, so the decision was taken to restrict it. Another factor that is weighing into the debate, although the experts recommend exercising some caution with this hypothesis, is that some studies have pointed the finger at genetics having an influence on the predisposition of British people to develop this complication.

Yet the UK is not the only country to ban its use. Nolotil is no longer prescribed in the USA, Australia, Sweden and India. However, the list of countries where it is still available to treat certain patients is longer (Belgium, Austria, Finland, Germany, the Netherlands, to name a few). "The most important thing is to stick to what is printed on the Instructions for Use leaflet in terms of dosage and duration of treatment and, above all, to advise the patient when and how to halt treatment," says Paredero.

Metamizole in Spain is only available on a doctor's prescription, so you cannot purchase it as an over-the-counter medicine at the pharmacy. Therefore, it is more difficult to self-medicate with it, putting yourself at risk. Still, what can happen is that many people save leftover drugs from previous prescriptions.

"This should never happen, take any leftovers to the recycling point at your nearest pharmacy," urges Del Arco.

"Be careful about taking something extra when you have another health issue because it may have nothing to do with it. For example, if your throat hurts, maybe last time it was due to a bacterial infection, but the one you have now is viral in origin."

"And another important thing, it doesn't matter if we are talking about metamizole or another analgesic, it should be used at the lowest dose where it is proving effective: taking more will not take away the pain any sooner, nor will taking twice the amount bring more relief. There is no linear relationship between dosage and pain relief. We can, however, draw a straight line, possibly even an upward curve, between dosage and adverse reactions to the medication."