EU drug watchdog investigates painkiller linked to deaths | Health

Europe’s medicines regulator has launched an investigation into a popular painkiller linked to a series of illnesses and deaths.

The European Medicines Agency (EMA), one of the EU’s top regulators, confirmed on Friday that it was reviewing the painkiller metamizole, which can cause agranulocytosis, a life-threatening condition in which a patient’s white blood cells are severely depleted.

It was revealed by Observer Last November, a group of patients in Spain had launched legal action against their government over accusations that it had failed to protect people from the drug’s side effects.

The drug, marketed in Spain under the brand name Nolotil, is already banned in several countries, including the United Kingdom. The EMA said there was “concern that measures implemented to minimize the known risk of agranulocytosis may not be sufficiently effective.”

The EMA review was requested by the Finnish medicines agency following recent cases of agranulocytosis. A company marketing metamizole in Finland had requested that its marketing authorization be withdrawn for safety reasons, the EMA said.

Spanish activist Cristina García del Campo welcomed the news of the EU investigation. Photography: Brochure

The regulator said: “The EMA safety committee will now review the risk of agranulocytosis for all metamizole-containing medicines authorized in the EU.

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

The agency said the product information on metamizole lists agranulocytosis as a rare side effect (occurring in up to 1 in 1,000 people) or a very rare side effect (up to 1 in 10,000). Measures to minimize this risk varied between countries, he said.

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The Association of Patients Affected by Medications (ADAF) in Spain says that adverse reactions to the drug have caused sepsis, amputations and deaths. It has identified around 350 suspected cases of agranulocytosis between 1996 and 2023, affecting 170 Britons who live or were on holiday in Spain.

The association’s legal action against Spain’s Ministry of Health and its medicines and health products agency alleges that the medicine has been offered without adequate controls. It is intended to be available only by prescription, but the Observer was able to purchase the medication without a prescription last November.

Cristina García del Campo, founder of ADAF, welcomed the research. She said: “This is great news. People are starting to notice these cases now. For years they have not been reported enough.”

In October 2018, the AEMPS published new guidelines for metamizole. He recommended avoiding its use by tourists and warning patients about the symptoms of agranulocytosis.

Nolotil’s maker, Boehringer Ingelheim, has said that adverse side effects are listed in the drug’s fact sheet and that the current prescribing information “adequately addresses current knowledge about the risks.” He has been contacted for comment on the EMA review.

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