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03-09-2019 | Rheumatology | News | Article

Regulatory update

EMA recommends new measures to avoid methotrexate dosing errors

medwireNews: The EMA has issued new precautions for the avoidance of dosing errors when using methotrexate for the treatment of inflammatory disorders such as rheumatoid arthritis and psoriasis.

“The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors,” said the EMA in a press release, noting that using methotrexate more frequently than once weekly for inflammatory conditions can result in “serious side effects,” including death.

The new measures stipulate that only physicians with experience in using methotrexate should prescribe the drug, and that the packaging should include “more prominent” warnings about the importance of once-weekly dosing. Moreover, methotrexate tablets will now be provided in blister packs in Europe to help ensure patients follow the correct dosing schedule.

While once-weekly low-dose methotrexate is approved for inflammatory conditions in EU, the dosing frequency is more variable when methotrexate is used for cancer treatment.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group