EMA recommends new methotrexate measures

The European Medicines Agency (EMA) has recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases.

The new recommendation covers diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease, and results from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors.

The recommendation states that for inflammatory conditions, methotrexate must be used just once a week and that using the chemotherapy agent more frequently than intended can result in serious side effects.

The review also found that the error in dosing frequency can occur at any step from prescribing the medicine to the patient taking it.

The new measures put in place to prevent errors include restricting who can prescribe the 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) – measures which 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. The treatment of cancer for which the dosing frequency depends on the regimen and can involve daily administration of methotrexate, and treatment of inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn’s disease, which require once-weekly use of a low dose.

The Pharmacovigilance Risk Assessment Committee (PRAC) initially recommended new measures in July, and the EMA adopted the agency’s decision. The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.

Methotrexate can be taken orally or given by injection.

Source: Anna Smith – Pharmatimes