EMA Recommends New Measures to Avoid Potentially Fatal Dosing Errors with Methotrexate

August 30, 2019
Pharmaceutical Technology Editors

EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

In an Aug. 23, 2019 press release, the European Medicines Agency (EMA) issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

The measures recommended by EMA include restrictions on those who are able to prescribe the medicine, increasing the prominence of the warnings on the medicine packs and providing healthcare professionals and patients with educational materials on the potential risks of dosing errors of methotrexate. These actions have been agreed upon after EMA consulted with healthcare professionals and patients and are set to avoid dosing errors of methotrexate, which can occur at any step and be serious and even potentially fatal.

Methotrexate is a medicine that must be used only once a week for the treatment of inflammatory diseases. A further measure that will be implemented to aid patients in keeping the correct dosing frequency will be to provide the medicine in blister packs rather than bottles or tubes.

Further information for patients and healthcare professionals is available on EMA’s website.

Source: EMA