The European Medicines Agency (EMA) has initiated a review of the risk of dosing errors with methotrexate medicines.
The EMA says some patients receiving methotrexate for inflammatory diseases have received treatment at the higher or more frequent doses indicated for cancer treatment. “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 agency says.
The risk of dosing errors with methotrexate has been recognised for many years and several measures are already in place in some European Union (EU) countries to reduce this risk, including the use of visual reminders on medicine packs. However, a recent periodic safety update report (PSUR) found that serious adverse events related to overdose, including fatalities, are still occurring. As a result, the Spanish medicines regulator, AEMPS, has asked the EMA to further investigate the reasons why dosing errors continue to occur, in order to identify measures to prevent them.
The 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.