The Medical Products Agency has suspended the marketing authorization for metamizole sodium (Novalgin: Hoechst Marion Roussel, 500 mg tablets and 500 mg/ml intravenous solution) with effect from 28 April 1999. The decision is based on a larger than expected number of reports of agranulocytosis in Sweden since 1996 (1 in 1,700).
Metamizole sodium was previously indicated for short-term management of acute, moderate to severe pain secondary to tissue damage, e.g. after surgical procedures, and colic pain, e.g. from the urinary or biliary tract.
Reference: EU/EEA Rapid Alert, Läkemedelsverket (Medical Products Agency), 28 April 1999.