Liver Injury Associated with the Selective Progesterone Modulator Ulipristal
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COMMENTARY
Liver Injury Associated with the Selective Progesterone Modulator Ulipristal Einar S. Björnsson1,2 Accepted: 13 September 2020 © Springer Nature Switzerland AG 2020
In most medical schools, the story of thalidomide has been told at some point, its use during pregnancy in Europe leading to birth defects in thousands of exposed children and how the US Food and Drug Administration (FDA) prevented its entry into the US market [1]. Approximately 40 years later in 1997, the FDA approved troglitazone, an antidiabetic drug, in the USA. In the middle of the same year, it was also marketed in the UK. However, after reports of liver failure, it was removed from the British market in December 1997 [2], but not from the US market. In 1998, a 55-year-old woman died of acute liver failure caused by troglitazone as a participant in a National Institutes of Health-sponsored study, but closely monitored by physicians [3]. However, it was not until the year 2000 that the FDA removed the drug from the market after reports of many deaths due to acute liver failure [4]. Up to 2003, over 200 cases of fatal hepatic reactions due to acute liver failure suspected to be related to troglitazone use were reported to VigiBase, the World Health Organization global database of individual case safety reports, the vast majority of which were from the USA [5]. Thus, both a restrictive and a liberal strategy by the FDA in terms of drug safety is illustrated by these examples above. Invited editorial on: “An evaluation of postmarketing reports of serious idiosyncratic liver injury associated with ulipristal acetat for the treatment of uterine fibroids” by Kang et al and "Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis" by Gatti et al. This comment refers to the articles available at https://doi. org/10.1007/s40264-020-00960-1 and https://doi.org/10.1007/ s40264-020-00975-8. * Einar S. Björnsson [email protected] 1
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Landspitali University Hospital, Hringbraut, Building H 101, Reykjavík, Iceland
Faculty of Medicine, University of Iceland, Reykjavík, Iceland
2
It is well known that a majority of adverse events including rare events are identified during the post-marketing phase of a drug when it is used in the wider population. Drug-induced liver injury (DILI) is one of the most common causes of withdrawal from the market of otherwise promising drugs [6]. In this issue of Drug Safety, two studies on DILI related to the use of a newly marketed selective progesterone receptor modulator, ulipristal acetate (UPA), illustrate this problem. In the first study, Kang et al. presented an evaluation of the FDA reports of suspected DILI associated with UPA [7]. In the second study, Gatti et al. [8] analysed the pharmacological properties of UPA to explore the pathophysiology of DILI due to this drug.
1 Indications, Mechanism of Action and History of Drug‑Induced Liver Injury Due to Ulipristal Acetate In 2012, UPA 5 mg
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