PRAC June 2019 – Start of referral: Leuprorelin-containing depot products

date: 24/06/2019

During its meeting of June 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for leuprorelin medicines. PRAC has started the review of handling errors with depot formulations of leuprorelin medicines

EMA has started a review of leuprorelin medicines after reports indicated that handling errors with the products during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment.

This review covers formulations called depot formulations which are given by injection under the skin or into a muscle and release the active substance slowly over 1 to 6 months. These include implants as well as powders and solvents for the preparation of injections.

Several of these formulations require complex steps to prepare the injection. Handling errors with these formulations have reportedly led to problems such as leakages from the syringe or failure to deliver implants from the applicator.

EMA’s safety committee, PRAC, will now evaluate 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 should carefully follow the handling instructions for leuprorelin medicines. Patients prescribed leuprorelin medicines who have any concerns should discuss them with their doctor.

In Belgium the only medicinal product containing leuprorelin is Depo-Eligard

More information is available on the EMA website

Last updated on 24/06/2019