NOLOTIL producers have warned against the ‘dangerous’ side effects of the drug – the country’s most popular painkiller.
It follows a campaign by the Olive Press and repeated calls from activists to limit and even ban the drug.
Last year an EU investigation declared it safe for use despite links to the deaths of at least 40 British and Irish expats in Spain.
Following the investigation, Nolotil producers have issued a warning detailing the symptoms of a side effect commonly seen in those who die after taking the medication.
Agranulocytosis, or the depletion of white blood cells, leads to a weakened immune system, organ failure and in some cases, death.
Though generally rare, it is more common amongst northern europeans due to genetic differences.
Despite a 2018 informative note by the Spanish Medicines Agency (AEMPs) warning doctors not to prescribe the painkiller to those vulnerable to dangerous side effects, several Brits have died after being given the drug.
The new warning, issued in December last year, describes the early signs of agranulocytosis, including fever, shivers, sore throat and pain in the mouth, nose and genitals.
It warns medical professionals ‘to remain vigilant to these symptoms as agranulocytosis can appear at any time during treatment, even just after it has finished.’
The note was overseen by the European Medicines Agency (EMA) and the Spanish Medicines Agency (AEMPs).
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According to AEMPs, the letter does not contain ‘anything new or worrying’, warning doctors to immediately terminate treatment if agranulocytosis symptoms are spotted.
The note also warned some of the symptoms described can ‘go unnoticed’ if the patient is suffering with the flu or taking antibiotics.
“If the symptoms suggest agranulocytosis, a blood test must be carried out immediately and treatment should be stopped while waiting for the results,” the letter warned, “if agranulocytosis is identified, treatment should not be restarted.”
The updated information follows the EMA review and is altered in both technical information for health professionals and the reports for the general public.
“This information is intended to minimise the severity of side effects associated with agranulocytosis as a result of medication containing metamizole (the main ingredient in Nolotil),” it said.
Such letters are sent to health professionals by email or through scientific societies. They are revised and approved by AEMPs to communicate new and important information.