Important safety information on the risk of overdose with methotrexate for oral use
05.03.2012
Following up on the letter to physicians (in Croatian) sent out in 2009, the Agency for Medicinal Products and Medical Devices (HALMED) is reminding prescribing physicians of the risk of overdose with methotrexate for oral use due to the incorrect daily application of the weekly dose in rheumatic and dermatological indications. Oral forms of methotrexate are not availabile in the Republic of Croatia, but are available to Croatian patients through imports.
Overdose with methotrexate for oral use due to the daily application of the weekly dose can be the consequence of the incorrectly prescribed or incorrectly applied drug. Cases of overdose due to daily application of the weekly dose were reported in the European Union between 2009 and 2011. In the reported cases, serious adverse reactions appeared and were fatal in some cases, especially due to the haemotological toxicity of methotrexate. Due to the above, the Working Group for Pharmacovigilance (PhVWP) of the European Medicines Agency (EMA) passed a recommendation in January 2012 on inclusion of information on the risk of overdose due to the daily application of the weekly dose in the Summary of Product Characteristics and the Patient Instructions of all medicinal products containing methotrexate that are registered in the European Union Member States.
Therefore, HALMED invites all health care professionals prescribing methotrexate for oral use to take caution while determining the drug dosage. Health care professionals are also called to consult patients on the proper application of methotrexate for oral use, so as to avoid the risks of daily application of the weekly dose of the drug.
HALMED has received one report to date of an overdose with methotrexate in a patient prescribed the weekly dose of the drug, but the patient accidentally took it every day. HALMED will continue to monitor the safety of use of methotrexate and the public will be informed of any new information in a timely manner.
We hereby remind all health care professionals that they are obliged to report every adverse reaction to medicinal products to HALMED (in Croatian). Patients developing an adverse reaction may also report the same directly to HALMED, with the recommendation that they consult their doctor or pharmacists regarding any adverse reactions they observe for consultations on the continuation of therapy.
