Revised SPC: Esmya 5 mg Tablets (ulipristal acetate)
SPC updated with more restricted licence of intermittent treatment of moderate/severe symptoms of uterine fibroids in pre-menopausal adults of reproductive age not eligible for surgery when uterine fibroid embolisation and/or surgical treatments are not suitable/have failed.
Source:
electronic Medicines compendium
SPS commentary:
SPC now also highlights that during the post-marketing experience, cases of hepatic failure have been reported. In a small number of these cases, liver transplantation was required. The frequency of occurrence of hepatic failure and patient risk factors are unknown.
In November, the EMA’s safety committee (PRAC) review of serious liver injury with ulipristal acetate 5 mg had found that it was not possible to identify either patients most at risk of liver injury or measures that could reduce the risk. The PRAC had therefore advised that these medicines should not be marketed in the EU. The CHMP endorsed the PRAC’s assessment of the risk of liver injury. However, it considered that the benefits of ulipristal acetate 5 mg in controlling fibroids may outweigh this risk in women who have no other treatment options. As a result, the CHMP recommended that the medicine remains available to treat premenopausal women who could not have surgery (or for whom surgery had not worked).