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EU regulators investigate painkillers


 

The European Medicines Agency has opened an inquiry into a well-known painkiller that has been connected to numerous illnesses and deaths.

One of the main EU regulators, the European Medicines Agency (EMA), announced on Friday that it was examining the medication metamizole. Agranulocytosis is a potentially lethal illness in which a patient’s white blood cells are significantly reduced.

The Observer reported in November of last year that a Spanish patient organisation had filed a lawsuit against the government on the grounds that it had not done enough to protect citizens from the adverse effects of the medication.

The medication, which is sold in Spain under the brand name Nolotil, is already prohibited in a number of nations, including the UK. “Concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough” were expressed by the EMA.

The Finnish pharmaceuticals agency sought the EMA’s review in response to recent agranulocytosis cases. According to the EMA, a Finnish business that sold metamizole had asked for the withdrawal of its market authorization due to safety concerns.

The EMA’s safety committee will now assess the risk of agranulocytosis for all metamizole-containing medications that are approved for use in the EU, according to the regulator.

“The committee will assess the impact of agranulocytosis on the benefit-risk balance of the medicines and issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked across the EU.”

Sepsis, amputations, and fatalities have been attributed to the drug’s adverse responses, according to the Spanish Association of Drug Affected Patients (ADAF).

Between 1996 and 2023, it has detected around 350 possible cases of agranulocytosis, affecting 170 British citizens who either reside in Spain or visited there for vacation.

The manufacturer of Nolotil, Boehringer Ingelheim, claims that the current prescribing information “adequately addresses current knowledge about risks” and that adverse side effects are indicated on the drug information sheet.

(Source: Guardian)


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