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Metamizole Safety In Spotlight As EMA Tackles Pregnancy/Lactation Labeling Disarray

 
• By Ian Schofield

More than 50 metamizole-containing medicines are being reviewed by the European Medicines Agency because of substantial differences in their national product labeling regarding dosage and contraindications in pregnant and breastfeeding women.

Spotlight
The dosage and use of metamizole is under spotlight in the EU

Companies marketing medicines containing the analgesic metamizole in the EU are being asked to supply information on the drugs’ sales, patient exposure, dosage and duration and treatment as part of an EU-wide review of “substantial” differences in labeling among the member states concerning maximum dosages and contraindications in pregnant and breastfeeding women.

Metamizole was first introduced into clinical use in Germany in 1922. While it is still available over the counter in...

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