July 29, 2021

Sanidad recommends not prescribing Nolotil to tourists after notification of "serious reactions" due to its use

Sanidad recommends not prescribing Nolotil to tourists after notification of "serious reactions" due to its use

The Spanish Agency for Medicines and Health Products (Aemps) recommends to healthcare professionals "not to use metamizole [Nolotil, en su nombre comercial más conocido] in patients in whom it is not possible to perform controls ", as is the case of tourists.

In a statement, the body under the Ministry of Health explains that, among the possible adverse reactions of the drug, is "the appearance of agranulocytosis or neutropenia" which, although being of "very low frequency", is a "serious reaction that can get to produce the death of the patient. " Although its origin is unknown, "it is considered an immune-type reaction," they add.

Aemps point out that the consumption of the drug has doubled in Spain in a decade, with a special rebound in the last 5 years: it went from 14.6 million containers in 2013 to 22.8 in 2017. In this way, the The agency has reviewed the cases of agranulocytosis reported in the Spanish Pharmacovigilance System.

Thus, agranulocytosis "has increased in recent years in parallel with the increase in consumption of this analgesic," although they do not rule out that "there is a significant under-reporting, as it is a known adverse reaction." Specifically, among these cases stand out those of British patients: "With the available information can not discard or confirm a higher risk in populations with specific ethnic characteristics."

"The data also confirm the increased risk in elderly patients, something already known," they comment in the note issued, in which they ask for "special precaution" when prescribing the drug in this age range.

The agency dependent on Health underlines "in more than half of the reported cases in which information is available", the duration of treatment with metamizol was greater than one week. Therefore, it is recommended "to use metamizol only for short-term treatments (7 days maximum), within its authorized indications and at the minimum effective doses": "If a longer treatment is necessary, perform periodic blood tests, including leukocyte formula" .


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