It’s not a new problem, but medical progress (and controversy) will be over.
On November 14, 2023, ADAF, an association of patients affected by the drug, condemned the Ministry of Health and the Spanish Agency for Medicines and Health Products for inaction in “real, adequate, updated and responsible pharmacovigilance” of Nolotil.
Four months later, the courts are studying it and it has again put the issue of metamizole, a widely used and controversial drug, on the table.
What exactly is metamizole? Metamizole (also known by its trade name ‘Nolotil’) is a nonsteroidal anti-inflammatory. Andn Spain, according to the indications of AEMPS, it is used as an analgesic, “in situations with moderate to severe acute pain” and, as an antipyretic, “when other options are not effective.”
Why is it controversial? The nuance of “in Spain” is important because its use is prohibited in many neighboring countries, such as France, the United Kingdom, the United States, Morocco or Sweden. This is because, although this drug had been on the market since 1922, in the 60s and 70s it was discovered that there was an epidemiological link between its consumption and agranulocytosis and neutropenia (disappearance or sudden decline of white blood cells).
That year, countries such as Canada, France, Sweden, Norway, and Australia phased out the drug, and over the next decade, countries such as the United States would follow suit. But other countries, such as Germany, Portugal, Italy, and generally most of the world, considered it a very rare side effect and that the benefits of its use outweighed the risks. Spain too.
Health has still maintained the same status.
However, it has been a long time since the seventies. Gradually, severe cases are increasing (from 1985 to 2017, 1,448 cases were identified, with 16% fatal) and the evidence is often overwhelming. But, above all, because pharmacosafety criteria are becoming more and more strict. As the capabilities of contemporary medicine emerge, risks that once seemed acceptable to us are now becoming too great.
And it looks like that’s the future for metamizole. Because, although AEMPS is correct that, “With the available information, a greater risk in populations with specific ethnic characteristics cannot be ruled out or confirmed” and the same agency strongly recommends against this type of drug in temporary populations. (for example, impossibility of monitoring), the progress of therapy will sooner or later eliminate Nolotil.
And this is not speculation, there are more and more clinical voices suggesting that we are “overdosing” metamizole or prescribing it unsafely; And this (even if we ignore the more serious side effects) has very serious health implications.
The problem is that we are not quite ready to come out of it. Because, away from the controversies, it is an increasingly used drug: According to prescription data collated from the National Health System, its use “has doubled over the past 10 years.”
The key to explaining this is that, unlike other NSAIDs, “it has good gastrointestinal tolerance and a low risk of causing digestive bleeding.” And that, in a context where demand for medicines related to digestive health is skyrocketing, is an increasingly powerful resource.
In short, this is how we are circling around a problem that is ultimately going to explode in our hands.
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