EMA makes recommendations to reduce methotrexate dosing errors


Only doctors with expertise in using methotrexate-containing medicines should be able to prescribe them, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended, as part of new measures to avoid ongoing dosing errors involving the drug.

Other measures include making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals.

The PRAC has also said that, to avoid confusion, recommendations to split the dose should be deleted from the product information for the tablet formulation and methotrexate being taken on a weekly basis should only be provided in blister packs, and not bottles.

Methotrexate-containing medicines are used to treat cancers and various inflammatory conditions, including rheumatoid arthritis and Crohn’s disease.

The risk of dosing errors with methotrexate-containing medicines is well known; mistakes made in prescribing or understanding the correct dosing schedule have led to patients taking the medicine daily instead of weekly, with serious consequences, including fatalities.

However, despite several measures already being put in place to reduce these errors, they have continued to be reported.

The PRAC’s measures were agreed after a consultation with patients and healthcare professionals. They will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt an opinion. Healthcare professionals will be informed in writing of any changes.


Last updated
The Pharmaceutical Journal, EMA makes recommendations to reduce methotrexate dosing errors;Online:DOI:10.1211/PJ.2019.20206815

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