New EU measures to avoid potentially fatal dosing errors with methotrexate

[Fred]

The European Medicines Agency (EMA) have set out new measures to avoid fatal dosing errors with methotrexate.

*The UK have said they will mirror the EMA advice.

Information for patients:

• If you are taking methotrexate for rheumatoid arthritis, psoriasis or Crohn’s disease, you must take it just once a week.
  
• Take your methotrexate medicine on the same day every week.
  
• Follow the instructions on the packaging of your methotrexate medicine.
  
• You will receive a patient card with your methotrexate tablets (or oral liquid). Read it carefully because it tells you how to take your medicine.
  
• Show your patient card to any new healthcare professional who treats you so that they know that you take your methotrexate medicine once a week.
  
• See your doctor at once if you get a sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness. These can be signs of taking too much methotrexate.
  
• Always attend your scheduled clinic visits and blood test appointments. They are important for making sure that your methotrexate medicine is working and that it is not causing any concern.
  
• If you are not sure about how to take your methotrexate medicine or you have any questions about it, talk to your doctor or pharmacist.
  

Information for healthcare professionals:

• 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.
    

Source: ema.europa.eu and gov.uk

Methotrexate