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.
The review will look into the risk of meningioma - a rare, usually non-malignant tumour of the membranes covering the brain and spinal cord, which can cause serious problems due to its location in the body - as a recent study in France suggested that the risk of meningioma, although very low, may be increased in people taking high doses of cyproterone for a long period.
The PRAC says that it will now examine the available evidence and make recommendations on the use of cyproterone-containing medicines across the EU.