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Regulatory Focus™ > News Articles > 2019 > 7 > EMA Warns of Dosing Errors With Methotrexate Drugs

EMA Warns of Dosing Errors With Methotrexate Drugs

Posted 15 July 2019 | By Michael Mezher 

EMA Warns of Dosing Errors With Methotrexate Drugs

The European Medicines Agency’s (EMA) on Friday released a set of recommendations for health care professionals to follow to avoid dosing errors with methotrexate-containing medicines.
The recommendations come after a review of dosing errors related to the drugs by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which was prompted by an Article 31 referral by Spain’s Agency of Medicines and Medical Products (AEMPS) last year.
According to the referral, a recent periodic safety update report (PSUR) identified 440 adverse reactions from a single marketing authorization holder that were due to dosing errors.
Methotrexate is commonly used to treat inflammatory diseases, such as arthritis and psoriasis, and some types of cancer.
EMA says the drug is typically taken once per week to treat inflammatory conditions but may be taken more frequently and at higher doses when used to treat cancer.
“Mistakes in prescribing or dispensing methotrexate as well as misunderstandings of the dosing schedule have led to patients taking the medicine daily instead of weekly for inflammatory diseases, with serious consequences, including fatalities,” EMA writes.
Based on its review, PRAC is recommending that methotrexate prescribing be restricted to physicians with expertise with the drugs and that healthcare professionals take steps to ensure patients can follow a once-weekly dosing schedule.
PRAC is also recommending that split doses be removed from the product information to avoid confusion and that packaging for once-weekly use “include a prominent reminder of how the medicine should be used.”
Additionally, PRAC recommends that methotrexate tablets be made available in blister packs rather than in bottles to help patients follow the appropriate dosing schedule.


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