Review prompted by continued reports of overdose

The European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines.

When used for inflammatory diseases, such as arthritis and psoriasis, methotrexate is taken once a week whereas for some types of cancer, the dose is higher and the medicine is used more frequently. Mistakes have led to some patients incorrectly receiving a dose every day instead of every week. As a result, patients have received too much of the medicine, with serious consequences in some cases.

The risk of dosing errors with methotrexate has been recognised for many years and several measures are already in place in some EU countries to reduce this risk, including the use of visual reminders on the medicine packs. However, a recent assessment1 found that serious adverse events related to overdose, including fatalities, are still occurring. The Spanish medicines regulator, AEMPS, therefore asked EMA to further investigate the reasons why dosing errors continue to occur in order to identify measures to prevent them.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now examine the available evidence and recommend whether further measures are needed to minimise the risk of dosing errors. The PRAC will also take into account the work of bodies specialising in patient safety.

Posteed on the EMA website on 13 April 2018