EMA safety committee takes steps to avoid methotrexate dosing errors

12 July 2019

At the July meeting of the European regulator’s safety watchdog, the Pharmacovigilance Risk Assessment Committee (PRAC), new measures were agreed to avoid dosing errors related to methotrexate-containing medicines.

Methotrexate is used for treating both inflammatory diseases and cancers. For certain cancers, a much higher dosage is needed, at a greater frequency.

Manufacturers include USA-based Antares Pharma (Nasdaq: ATRS), which in 2015 regained US marketing rights to Otrexup (methotrexate), and Medac Pharma, which markets Rasuvo (methotrexate). Medac is an American wholly-owned subsidiary of private German firm Medac GmbH.

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