The Committee for risk assessment in the field of pharmacovigilance (PRAC) of the European Agency of medicines (EMA) conducts a risk-benefit analysis of the use of the drug has ulipristal after reports of serious liver damage, including liver failure leading to transplantation.
At the time of the survey as a temporary measure, the PRAC EMA experts recommend regular monitoring of liver women taking ulipristal when you have uterine fibroids.
All women taking ulipristal has recommended the test to check liver function at least once a month during treatment. Upon receipt of the results do not conform to the norm (the levels of the liver enzymes exceed more than two times the upper limit of normal), the doctor should discontinue therapy and carefully monitor the patient. The test should be repeated after 2-4 weeks after cessation of treatment, according to a statement on the EMA website.
Experts PRAC EMA also recommended that patients did not start therapy with ulipristal, and patients who completed course of treatment continued therapy.
It is noted that these guidelines are interim measures for the protection of the patients until completion of the review of the risks and benefits of the application ulipristal, beginning in December 2017.
Ulipristal has been registered in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids in women who have not yet reached menopause. The drug was recommended for use within three months before undergoing surgery to remove the fibroids, but could also be used for a long time, but with breaks in the treatment.
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