EMA's PRAC to view methotrexate and HES

13 April 2018

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has released highlights from its meeting that took place April 9-12.

The PRAC has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.

When used for inflammatory diseases, 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, with serious consequences in some cases.

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