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Regulatory Focus™ > News Articles > 2019 > 6 > EMA Begins Review of Handling Errors Linked to Leuprorelin

EMA Begins Review of Handling Errors Linked to Leuprorelin

Posted 17 June 2019 | By Zachary Brennan 

EMA Begins Review of Handling Errors Linked to Leuprorelin

At the request of Germany’s BfArM, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review of depot formulations of leuprorelin medicines because of reports of handling errors during preparation and administration that can cause some to receive insufficient amounts.

EMA explains how depot formulations of leuprorelin medicines, which are better known by different brand names like Eligard, Lupron and Procren, release the active substance gradually and are used to treat prostate cancer, breast cancer and conditions that affect the female reproductive system.

“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 said.

For Eligard, between the start of 2012 and the end of 2018, there were 2,271 cases of handling errors reported, and in 120 cases, a lack of efficacy was reported to be associated with handling errors. EMA also said “significant underreporting has to be assumed.”

Although a new safety needle was introduced to Eligard in 2019, PRAC found that an analysis of EudraVigilance for all leuprorelin-containing products “shows that the risk of medication errors is not limited to Eligard.”

PRAC has called on marketing authorization holders (MAH) of leuprorelin medicines to address questions related to estimated patient exposure, case reports of medication errors, all steps of the product preparation and administration and risk minimization measures to address the issue of medication errors and product issues.

A recommendation by PRAC may come as soon as November.



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Tags: EMA, leuprorelin, PRAC