EMA's PRAC concludes review of new info on HRT; leuprorelin depot meds guidance

16 May 2020

At its May 11-14 meetings, the European Medicines Agency’s Pharmacovigilance Risk Committee (PRAC) recommends updating the current safety information for hormone replacement therapy (HRT) used to treat symptoms of the menopause.

The updates are based on evidence from a large study published in The Lancet in August 2019, which confirmed the known higher risk of breast cancer in women using HRT. Furthermore, the results showed that the risk may continue to be increased for ten years or more after stopping HRT, if it has been used for more than five years.

Having assessed all available evidence, the PRAC recommends changes in the product information for implementation by authorities to reflect the following updates:

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