Journal
EXPERT OPINION ON DRUG SAFETY
Volume 17, Issue 12, Pages 1225-1232Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/14740338.2018.1550070
Keywords
Drug-induced liver injury; DILI; ulipristal acetate; transaminases; bilirubin; safety
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Funding
- PregLem S.A.
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Introduction: Uterine fibroids are benign tumors within the uterine wall affecting women. Ulipristal acetate 5 mg was first authorized in the European Union on 23 February 2012, with a post-marketing exposure estimated to be more than 765,000 patients so far. During the post-marketing experience, sporadic cases of liver injury and hepatic failure were reported. A detailed review of the clinical trials carried out in the development of ulipristal acetate 5 mg was undertaken to further assess the liver safety data reported during the clinical trials. Areas covered: A detailed review of clinical data from Phase I to Phase III of patients exposed to ulipristal acetate at any investigated dose levels and for any treatment duration was conducted and the liver function test values are presented. In addition, a literature review on drug-induced liver injury is provided Expert opinion: The experts present an evaluation of the liver safety findings observed during the clinical development and their views on the role of these findings in predicting the occurrence of drug-induced liver injury, the benefits of the treatment, the safety and the implications to the current clinical practice.
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