Template:Published case reports of cyproterone acetate-associated liver toxicity

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Published case reports of cyproterone acetate-associated liver toxicity
# Sex Age Dosage Type Onset Outcome Survivala Ref Link
1 Female 73 years 400 mg/day AH 2.5 months Survived N/A Meijers et al. (1986) [1]
2 Female 85 years 200 mg/day AH 4.8 months Survived N/A Meijers et al. (1986) [1]
3 Male 78 years 200 mg/day ALF 6 months Death 2 weeks Lévesque et al. (1989) [2]
4 Male 71 years 300 mg/day AH 5.3 months Survived N/A Blake et al. (1990) [3]
5 Male 79 years 200–300 mg/day AH 2.5 months Survived N/A Dore et al. (1990) [4]
6 Male 80 years 200 mg/day ALF 7 months Death ~1–2 months Antoni et al. (1991) [5]
7 Male 75 years 300 mg/day HCC 1.5 years ND ND Ohri et al. (1991) [6]
8 Male 72 years 300 mg/day ALF ND Survived N/A Parys et al. (1991) [7]
9 Male 65 years 300 mg/day ALF 1 year Death 1.6 months Parys et al. (1991) [7]
10 Male 83 years 300 mg/day ALF 1.25 years Death 2 weeks Parys et al. (1991) [7]
11 Male 78 years 150 mg/day AH ~3 months Survived N/A Drakos et al. (1992) [8]
12 Female 24 years 100 mg/day (RS) CH 3 months Survived N/A Hassler et al. (1992) [9]
13 Male 74 years 200 mg/day AH 11 months Survived N/A Roila et al. (1993) [10]
14 Male 79 years 300 mg/day ALF 10 months Death 2 weeks Bressollette et al. (1994) [11]
15 Male 92 years 100 mg/day ALF 4 months Death 5 weeks Hirsch et al. (1994) [12]
16 Male 65 years 600 mg/day HCC 4 months Survived N/A Kattan et al. (1994) [13]
17 Female 22 years 100–250 mg/day HCC 10 years Death 9 months Watanabe et al. (1994) [14][15]
18 Female 19 years 200–300 mg/day HCC 9 years Survived N/A Watanabe et al. (1994) [14][15]
19 Female 19 years 200 mg/day HCC ~10 years Survived N/A Watanabe et al. (1994) [14][15]
20 Male 87 years 200 mg/day ALF 4 months Death ~3.5 weeks Pinganaud et al. (1995) [16]
21 Male 78 years 150 mg/day ALF 1 year Death 3 weeks Pinganaud et al. (1995) [16]
22 Female 45 years 2 mg/day (BCP) HCC 14 years Death 9 months Rüdiger et al. (1995) [17]
23 Male 78 years 200–300 mg/day ALF 3 months Death 9 months Castellani et al. (1996) [18]
24 Male 73 years 300 mg/day ALF 4 months Survived N/A Murphy et al. (1996) [19]
25 Male 64 years 100 mg/day AH 6 months Survived N/A Ruiz-Rebollo et al. (1997) [20]
26 Female ≥8 years 200–300 mg/day HCC >4 years Survived N/A Watanabe et al. (1997) [15]
27 Male 21 years 100–350 mg/day HCC 15 years Survived N/A Watanabe et al. (1997) [15]
28 Male 84 years ND ALF ND Death 1 week Lombardi et al. (1998) [21]
29 Male 81 years 300 mg/day ALF 6 months Death 1.6 months Friedman et al. (1999) [22]
30 Male 66 years 300 mg/day ALF 2 months Death 4 weeks Friedman et al. (1999) [22]
31 Male 14 years 100 mg/day Cirrhosis ~7.5 years Death ~1 year Garty et al. (1999) [23]
32 Male 84 years 100–300 mg/day HCC 10 years Death 6 days Manfredi et al. (2000) [24]
33 Male 87 years 300 mg/day AH ND Survived N/A Giordano et al. (2001) [25]
34 Female 17 years 2 mg/day (BCP) AIH/cirrhosis 2 months Survived N/A Kacar et al. (2002) [26]
35 Male 76 years 150 mg/day AH 7 months Survived N/A Manolakopoulos et al. (2004) [27]
36 Male 78 years 200 mg/day ALF 3 months Death 1.0 months Famularo et al. (2005) [28]
37 Male 82 years 200 mg/day AH 12 months Survived N/A Savidou et al. (2006) [29]
38 Male 83 years 300 mg/day AH 7 months Death 1.4 months Savidou et al. (2006) [29]
39 Male 78 years 300 mg/day AH 3 months Survived N/A Savidou et al. (2006) [29]
40 Male 78 years 150 mg/day ALF 2 months Survived N/A Miquel et al. (2007) [30]
41b Female 22 years 2 mg/day (BCP) BCS 7 days ND ND He et al. (2009) [31][32]
42 Male 89 years 150–300 mg/day ALF 3.2 months Death 28 days Kim et al. (2009) [33]
43 Male 71 years 100–200 mg/day ALF 2–3 months Death 20 days Hsu et al. (2011) [34]
44 Male 66 years 200 mg/day AH/cirrhosis 4 months Survived N/A Abenavoli et al. (2013) [35]
45 Male 75 years 200 mg/day ALF 9 months Survived N/A Vodička et al. (2013) [36]
46 Male 87 years 200 mg/day ALF 6 months Death 20 days Kim et al. (2014) [37]
47 Male 80 years 150 mg/day AH 4.0 months Survived N/A Bessone et al. (2016) [38]
48 Male 73 years 200 mg/day AH 2.1 months Survived N/A Bessone et al. (2016) [38]
49 Male 54 years 200 mg/day AIH 4.0 months Survived N/A Bessone et al. (2016) [38]
50 Male 60 years 200 mg/day AH 1.1 months Survived N/A Bessone et al. (2016) [38]
51 Male 74 years 200 mg/day AH 5.1 months Survived N/A Bessone et al. (2016) [38]
52 Male 66 years 150 mg/day ALF 3.2 months Death ND Bessone et al. (2016) [38]
53 Male 77 years 100 mg/day AH 8.1 months Survived N/A Bessone et al. (2016) [38]
54 Male 72 years 200 mg/day AH 5.0 months Survived N/A Bessone et al. (2016) [38]
55 Male 80 years 200 mg/day AH 1.9 months Survived N/A Bessone et al. (2016) [38]
56 Male 69 years 100 mg/day AH 4.1 months Survived N/A Bessone et al. (2016) [38]
57 Male 58 years 200 mg/day AH 10.1 months Survived N/A Bessone et al. (2016) [38]
58 Male 83 years 100 mg/day AH 2.1 months Survived N/A Bessone et al. (2016) [38]
59 Male 75 years 200 mg/day AH 4.9 months Survived N/A Bessone et al. (2016) [38]
60 Male 72 years 100 mg/day AH 8.0 months Survived N/A Bessone et al. (2016) [38]
61 Male 72 years 50 mg/day AH 5.9 months Survived N/A Bessone et al. (2016) [38]
62 Male 66 years 100 mg/day AH/CH 1.2 years Survived N/A Bessone et al. (2016) [38]
63 Male 58 years 200 mg/day ALF 5.0 months Death ND Bessone et al. (2016) [38]
64 Male 75 years 200 mg/day ALF 7.9 months Death ND Bessone et al. (2016) [38]
65 Male 74 years 150 mg/day AH 9.9 months Survived N/A Bessone et al. (2016) [38]
66 Male 64 years 100 mg/day AH 3.3 months Survived N/A Bessone et al. (2016) [38]
67 Male 64 years 150 mg/day AH/CH 4.9 months Survived N/A Bessone et al. (2016) [38]
68 Male 64 years 150 mg/day AH/cirrhosis 4.9 months Survived N/A Bessone et al. (2016) [38]
69 Male 61 years 300 mg/day ALF 3 months Death 2.6 months Nour et al. (2017) [39]
70 Female 30 years 25 mg/day ALF 6 months Death 4 days Kumar et al. (2021) [40]
Abbreviations: BCP = Birth control pill. RS = Reverse sequential (days 5–25 of cycle). ALF = Acute liver failure (fulminant liver failure). AH = Acute hepatitis. CH = Cholestatic hepatitis. AIH = Autoimmune hepatitis. HCC = Hepatocellular carcinoma. BCS = Budd–Chiari syndrome. ND = No data. N/A = Not applicable. Footnotes: a = Time until death after onset of liver toxicity. b = Probably related to ethinylestradiol rather than to cyproterone acetate.[31] Notes: Many additional cases have been described in spontaneous adverse drug reaction reporting systems of individual countries. These include 19 cases (5 deaths) by late 1988[3] and 96 cases (91 males, 5 females; 33 deaths) by early 1995 in the United Kingdom;[41][42] 32 cases (deaths not given) in Australia by 2004;[43] and 15 cases (no deaths) in Spain by 2006.[44] The cases from Bessone et al. (2016) were reported between 1993 and 2013 and were from Spanish and Latin American drug-induced liver injury databases (17 cases in Argentina, 2 cases in Uruguay, 3 cases in Spain).[38] Worldwide, 153 cases of liver abnormalities were reported to Schering, the manufacturer, between 1982 and 1987.[3] In a large observational study of 2,506 patients, Heinemann et al. (1997) reported 7 cases of benign liver tumors and no cases of serious liver toxicity or HCC.[45] Large observational studies have found no increased risk of liver toxicity or HCC with cyproterone acetate at BCP doses.[45][46][47] A fatal case of ALF in a common chimpanzee has also been reported.[48] Sources: [29][49][22]
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