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Hysterectomy, myomectomy or embolization may offer symptomatic relief, but are costly, include a recovery period, can cause serious side\u2010effects, sometimes fail to treat symptoms completely and are not always desired by patients. Ulipristal is a conservative long\u2010term treatment that has a fibroid\u2010volume decreasing effect, acceptable side\u2010effects while preserving fertility and may be an alternative to surgical alternatives. Currently, ulipristal is investigated by the European Medicine Agency and suspended from marketing authorization because it may cause drug\u2010induced liver injury (DILI). However, many drugs can cause severe DILI and prospective studies estimate 14\u201319 DILI cases\/100\u2009000 people.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This overview will discuss the risk\u2013benefit balance between ulipristal and DILI, describe the safety\u2013efficacy balance of ulipristal and its alternative treatments and the arguments that led to the suspension of its marketing authorization.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ulipristal may be associated with DILI resulting in a risk of severe liver injury in 1.5:100\u2009000 patients and fatal liver injury in 0.1:100\u2009000 patients. This risk needs to be weighed against the higher mortality risk of &gt;1:1000 and higher incidence of severe complications after surgery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The DILI risk of ulipristal is considerably lower than that of other medicines that are not suspended, nor need additional safety measures. When evaluating drugs and drug safety, risks that apply to the alternative nonpharmacological treatment options should be taken into consideration.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14708","type":"journal-article","created":{"date-parts":[[2020,12,19]],"date-time":"2020-12-19T22:19:36Z","timestamp":1608416376000},"page":"2685-2697","source":"Crossref","is-referenced-by-count":20,"title":["Risk\u2013efficacy balance of ulipristal acetate compared to surgical alternatives"],"prefix":"10.1111","volume":"87","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0847-2566","authenticated-orcid":false,"given":"Mei\u2010An","family":"Middelkoop","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development research institute Amsterdam UMC, Vrije Universiteit Amsterdam  Amsterdam The Netherlands"},{"name":"Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development research institute Amsterdam UMC  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