New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
EMA has recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors.
For inflammatory conditions, methotrexate must be used just once a week. Using methotrexate more frequently than intended can result in serious side effects. The review found that the error in dosing frequency can occur at any step from prescribing the medicine to the patient taking it.
The new measures to prevent errors include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing, methotrexate tablets will be provided in blister packs and not in bottles (or tubes).
The measures were agreed after consultation with patients and healthcare professionals.
Methotrexate is authorised in the EU for two different groups of indications, each with a different administration schedule: treatment of cancer for which the dosing frequency depends on the regimen and can involve daily administration of methotrexate; treatment of inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn’s disease, which require once-weekly use of a low dose of methotrexate.