The European Medicines Agency (EMA) has initiated a review of leuprorelin medicines after reports that handling errors in the preparation and administration of these products can cause some patients to receive insufficient dose concentrations.
The EMA says several of these formulations require complex preparation, and handling errors in the preparation and administration process have reportedly led to problems such as leakages from the syringe or failure to deliver implants from the applicator.
At the request of the German medicines regulator agency, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now review all available data and determine whether measures are needed to ensure that the medicines are prepared and administered appropriately.
While the review is ongoing, healthcare professionals are advised to carefully follow the handling instructions for leuprorelin medicines.
Daily leuprorelin injections are not included in the review as there have been no reports of handling errors with this formulation.
Based on the findings, the PRAC will make recommendations to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), the body responsible for harmonising drug safety standards in EU Member States as well as Iceland, Liechtenstein and Norway.