Risk of Methotrexate Dosing Errors Prompts EMA Review

Megan Brooks


April 13, 2018

The European Medicines Agency (EMA) is reviewing the risk of dosing errors with medicines containing methotrexate. The review is based on "continued reports of overdose," the agency announced today.

Methotrexate is used to treat various inflammatory conditions, such as arthritis, psoriasis, and some cancers, such as acute lymphoblastic leukemia. Methotrexate can be taken by mouth or given by injection. For inflammatory diseases, methotrexate is taken once a week; higher doses given more frequently may be used for the treatment of cancer.

The risk of dosing errors with methotrexate has been known for many years, and several European Union countries have various measures in place to reduce this risk, including the use of visual reminders on medicine packs.

However, the EMA said a recent routine assessment found that serious adverse events related to overdose, including fatalities, are still occurring.

"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 EMA said in a statement announcing the review.

The Spanish Agency for Medicines and Health Products asked the EMA to further investigate the reasons why dosing errors continue to occur in order to identify new measures to prevent them.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will examine the available evidence and recommend whether further measures are needed to minimize the risk of dosing errors with methotrexate.

When complete, the PRAC recommendations will be sent to the Committee for Medicinal Products for Human Use, which will adopt a final opinion.

Methotrexate is marketed in all EU countries under several brand names, including Ledertrexate, Maxtrex, Metex, Metoject, Jylamvo, and Nordimet.

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