Metamizole (also known as dipyrone) is a potent analgesic, antipyretic and nonsteroidal anti‐inflammatory drug (NSAID) used in the treatment of pain, fever, and spasms. This medicine was introduced into the market nearly 100 years ago. Due to serious adverse drug reactions like agranulocytosis, this medicine was withdrawn in many countries. However, it is available as prescription medicine in few countries and as an over the counter (OTC) medicinal product in some countries.
European Medicines Agency (EMA) released a direct health care professional letter (DHPC) pertaining to the risk of drug-induced liver injury (DILI) by metamizole.
Summary of letter:
- Cases of drug-induced liver injury (DILI) with metamizole have been reported
- Metamizole should not be reintroduced in patients with an episode of hepatic injury during treatment with metamizole, for which no other cause of liver injury has been determined.
- The labelling information contained in sections 4.4. (“Warnings and precautions”) and 4.8 (“Adverse reactions”) of the Summary of Product Characteristics (SmPC) as well as the Package Leaflet are being updated accordingly.
- Patients need to be educated on how to recognise early symptoms suggestive of drug-induced liver injury and to stop the use of metamizole should such symptoms occur, and to seek medical assistance in order to assess and monitor liver function.
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