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Ulipristal for uterine fibroids – safety update

In February 2018, the European Medicine Agency Pharmacovigilance Risk Assessment Committee (PRAC) issued temporary recommendations that no new patients should be started on Esmya (ulipristal acetate), following reports of serious injury. The PRAC has completed its review of Esmya. The Committee has now concluded that new patients can start treatment in line with the above recommendations to minimise the risk of liver injury, with the following precautions:

  • Esmya must not be used in women with known liver problems.
  • A liver function test should be performed before starting each treatment course and treatment must not be started if liver enzyme levels are more than 2 times the upper limit of normal.
  • Liver function tests should be performed once a month during the first two treatment courses and two to four weeks after stopping treatment. If the test is abnormal (liver enzyme levels more than 3 times the upper limit of normal), the doctor should stop treatment and closely monitor the patient.
  • Esmya should be used for more than one treatment course only in women who are not eligible for surgery. Women who are about to have surgery should continue to use only one course.
  • A card will be included in the box of the medicine to inform patients about the need for liver monitoring, and to contact their doctor should they develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
  • Studies should be performed to determine the effects of Esmya on the liver and whether these measures are effectively minimising the risks.

Details available on the EMA website.