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Pharmacovigilance / «Citizens»

Review triggered by cases of liver injury

The European Medicines Agency (EMA) has started a review of the medicine Esmya (ulipristal acetate) used to treat uterine fibroids (non-cancerous tumours of the womb). This follows four reports of serious liver injury, three of which ended in liver transplantation, in patients treated with the medicine. It is estimated that around 670,000 patients have been treated with Esmya to date. While the review is ongoing, patients should contact their doctor if they have any questions or concerns about their treatment.

More information:

Esmya. EMA starts review of Esmya for uterine fibroids

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