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EMA recommends limiting use of methotrexate for inflammatory diseases

The European Medicines Agency sent a letter to healthcare providers and patients informing them of new measures to avoid serious and potentially fatal errors with the dosing of methotrexate, including limiting its use as a treatment for inflammatory diseases.

Methotrexate is chemotherapy agent and immune suppressant and is approved in EU for the treatment of cancer and inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn's disease.

The agency issued a letter Aug. 23, saying that methotrexate must be used just once a week in patients with inflammatory diseases to avoid serious side effects. In cancer patients, the dosing frequency would be dependent on the regimen and can include more frequent administration.

The letter was issued after the Pharmacovigilance Risk Assessment Committee reviewed medicines containing methotrexate at the request of the Spanish Agency for Medicines and Health Products. A final decision on the use of the drug is still pending by the EMA.

Methotrexate, a generic drug, is available under several brand names including Ledertrexate, Maxtrex, Metex and Metoject. Jylamvo and Nordimet are the only centrally authorized medicines containing methotrexate. It first came into use in 1947, and according to one estimate, was the 152nd most-prescribed drug in the U.S. in 2019.