EU drug agency investigates painkillers linked to deaths | health

An investigation has been launched by the European medicines regulator into a popular painkiller linked to a series of illnesses and deaths.

The European Medicines Agency (EMA), one of the EU’s biggest regulators, confirmed on Friday that it was reviewing the painkiller metamizole, which can lead to agranulocytosis, a potentially fatal condition in which white blood cells of a patient are severely depleted.

It was discovered by watchdog Last November, a group of patients in Spain launched legal action against their government over claims 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 UK. The EMA said it had “concerns that measures in place to minimize the known risk of agranulocytosis may not be effective enough”.

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

The regulator said: “EMA’s 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 the medicines and make a recommendation whether their marketing authorizations should be maintained, varied, suspended or revoked across the EU.

The agency said the product information on metamizole lists agranulocytosis as either 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 from country to country, he said.

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

The association’s legal action against Spain’s health ministry and its medicines and health products agency alleges the drug was offered without proper controls. It’s supposed to be available by prescription only, but watchdog was able to buy the drug without a prescription last November.

Cristina García del Campo, the founder of ADAF, welcomed the investigation. She said: “This is great news. People are starting to notice these cases now. They have been under-reported for years.”

In October 2018, AEMPS issued new guidelines for metamizole. He recommended that its use be avoided by tourists and that patients be informed about the symptoms of agranulocytosis.

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