How safe is Nolotil?

2023-12-03 21:58:28

According to some studiesNolotil is the best-selling medicine in Spain, with nearly 24 million containers dispensed in pharmacies each year.

Recently, the popular medication has gained even more notoriety when it became known that the Association of People Affected by Drugs (ADAF) had demanded to the Spanish Ministry of Health and the Spanish Agency for Medicines and Health Products (AEMPS) for failing to protect British citizens from their adverse reactions – even fatal – while they were in Spain. It should be noted that Nolotil is not marketed in the United Kingdom, among other countries, and that those affected were mostly tourists.

Given this type of news, it is logical that some concern has arisen among public opinion. How safe is Nolotil? And what is the reason for his popularity? Is it really more effective at relieving pain than other medications?

Since 1969 in its pharmacies

Nolotil has been marketed in Spain since 1969 to treat acute moderate or intense postoperative or post-traumatic pain, of colic type or of tumor origin, as well as high fever that does not respond to other therapeutic measures, including first-choice antipyretics. As well established your technical sheet and prospectusthese are its approved indications and, therefore, it should not be used for other types of pain.

Considered a non-steroidal anti-inflammatory drug (NSAID), its active ingredient is known as metamizole or dipyrone. NSAIDs, the most commonly used group of anti-inflammatories, produce an analgesic, antipyretic (fever reduction) and anti-inflammatory effect through the inhibition of cyclooxygenase enzymes, but they can also negatively affect the digestive system.

Within this group we find well-known drugs such as paracetamol, ibuprofen, diclofenac, dexketoprofen, naproxen, celecoxib, etc. But not all NSAIDs are the same and generate the same effects. For example, paracetamol does not have anti-inflammatory action and is not gastro-injurious.

Advantages of metamizole

Metamizole, which is part of more than twenty commercial medications in the form of capsules, oral drops, suppositories or even as an injectable solution, also has its peculiarities. In addition to the therapeutic effects on pain, inflammation and fever that it shares with other NSAIDs, this active ingredient has antispasmodic properties, useful for relieving colic-type pain. It has also been seen to work well in cancer patients in whom conventional NSAIDs such as paracetamol or ibuprofen do not resolve the fever and pain processes.

And why has its use become so massively popular in Spain? Due to its low price, its availability and because the profile of gastrointestinal and renal adverse reactions seems more favorable compared to other NSAIDs such as ibuprofen.

The main problem is that it is often not used properly, including due to medical malpractice. For example, it is very common to find people who use Nolotil or metamizole for headaches, musculoskeletal pain or stomach discomfort. There are even patients who drink the injectable ampoules, self-administering practically a dose four times higher than that contained in a capsule.

The unwanted effect that sets off alarm bells

If we talk about safety, one of the most common adverse reactions is hypotension. However, the main problem with metamizole is a rare, unwanted type of response known as agranulocytosis. As its name indicates, agranulocytosis is a decrease in granulocytes, cells of the immune system such as eosinophils, neutrophils or basophils that help us defend ourselves against infectious agents.

This reaction causes fever, chills, oropharyngeal pain, rhinitis, pharyngitis, inflammation of the genital tract and anal inflammation. In the most serious cases it can be fatal, by limiting the body’s defenses against bacteria, viruses or other pathogens. It has also been noted that clozapine, an antipsychotic drug, can cause agranulocytosis.

These serious adverse reactions on the immune system are responsible for metamizole not being available in all European countries: not marketed in France, the United Kingdom and Scandinavian countries such as Sweden, Norway or Denmark.

It seems that the inhabitants of northern Europe are more susceptible to this type of response, probably due to pharmacogenetic reasons. This concept refers to the role of some genes in the biotransformation and elimination of drugs from the body. Recent studies reveal that some types of patients have a genetic predisposition to suffer agranulocytosis by not rapidly detoxifying metamizole from the body due to polymorphisms in the NAT2, CYP2C9 and CYP2C19 genes.

Related news

With all this information, the European Medicines Agency (EMA) and the Spanish Agency for Medicines and Health Products (AEMPS) They already issued a warning in 2018 remembering that metamizole is a drug subject to medical prescription and should be used only for short-term treatments at the minimum effective doses, monitoring the appearance of symptoms indicative of agranulocytosis.

Due to these risks and the damage caused to some patients, certain patient associations have taken legal action against the AEMPS, as we mentioned at the beginning of the article. However, we must not forget that, under appropriate conditions of use and prescription, metamizole is an effective therapeutic option to control fever and pain in some types of patients, such as cancer patients.