EU: PRAC recommends new measures for methotrexate

17-07-2019

EU: PRAC recommends new measures for methotrexate

(Source: PharmaTimes 2019-07-18)

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly.

The decision was made at the committee’s latest meeting on 8-11th of July, where it examined the available evidence and recommended additional measures to reduce dosing errors.

These include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. Also, to help patients follow the once-weekly dosing, methotrexate tablets for weekly use will be provided in blister packs and not in bottles or tubes.

The safety committee also started a review of medicines containing cyproterone, which are used for treating a range of conditions, including excessive hair growth, prostate cancer and acne, as well as in hormone replacement therapy.

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