Methotrexate must be used just once a week to treat inflammatory diseases and should only be prescribed by physicians with expertise in prescribing the drug, according to new guidance from the European Medical Association.
The new ‘risk minimization’ measures are the result of a review of reports that patients are continuing to use methotrexate incorrectly, despite previous measures to prevent error, the agency says.
For example, 440 cases of adverse reactions due to inappropriate drug administration were recorded between July 2014 and June 2017 – 335 of which came from Germany, France, Italy, Spain and the UK. The majority of cases were reported in patients taking MTX orally.
According to the EMA, healthcare professionals should follow these recommendations:
- Methotrexate for inflammatory conditions is intended for use just once a week. Serious side effects including fatalities have occurred when methotrexate is taken more often.
- Only physicians with expertise in using methotrexate medicines should prescribe them.
- Healthcare professionals who prescribe or dispense methotrexate for inflammatory conditions should:
- read the educational materials for oral methotrexate medicines;
- ensure that they are familiar with the latest changes to the summaries of product characteristics for methotrexate medicines used for inflammatory conditions;
- give clear instructions to the patient (or carer) about once-weekly dosing;
- check carefully that the patient (or carer) understands that the medicine must be used once a week, and do this each time a new prescription is issued or the medicine is dispensed;
- decide together with the patient (or carer) on which day of the week the patient uses methotrexate;
- counsel the patient (or carer) about signs of methotrexate overdose and give instructions to promptly seek medical advice in case of suspected overdose.