Template:Published case reports of cyproterone acetate-associated liver toxicity
Appearance
# | 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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See also
References
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- ^ Lévesque H, Trivalle C, Manchon ND, Vinel JP, Moore N, Hémet J, Courtois H, Bercoff E, Bourreille J (January 1989). "Fulminant hepatitis due to cyproterone acetate". Lancet. 1 (8631): 215–6. doi:10.1016/S0140-6736(89)91225-7. PMID 2563116. S2CID 45452406.
- ^ a b c Blake JC, Sawyerr AM, Dooley JS, Scheuer PJ, McIntyre N (May 1990). "Severe hepatitis caused by cyproterone acetate". Gut. 31 (5): 556–7. doi:10.1136/gut.31.5.556. PMC 1378574. PMID 2140997.
Although few case reports have been published, the Committee on Safety of Medicines had received 19 reports in the UK of adverse hepatic reactions associated with cyproterone acetate by November 1988 (personal communication, Committee on Safety of Medicines). Five of these cases were fatal.
- ^ Dore B, Orget J, Irani J, Aubert J (1990). "Hépatite après traitement par acétate de cyprotérone. A propos d'un cas" [Hepatitis after treatment with cyproterone acetate. Apropos of a case]. J Urol (Paris) (in French). 96 (3): 169–71. ISSN 0248-0018. PMID 2145371.
- ^ Antoni M, Bourlière M, Toullec J, Maillot A, Botta-Fridlund D, Gauthier A (1991). "Hepatite sub-fulminante d'evolution mortelle a l'acetate de cyproterone" [Fatal subfulminant hepatitis caused by cyproterone acetate]. Gastroenterol. Clin. Biol. (in French). 15 (10): 772–3. ISSN 0399-8320. PMID 1840042.
- ^ Ohri SK, Gaer JA, Keane PF (February 1991). "Hepatocellular carcinoma and treatment with cyproterone acetate". Br J Urol. 67 (2): 213. doi:10.1111/j.1464-410X.1991.tb15113.x. PMID 1848454.
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- ^ Hassler P, Duchêne R (1992). "Hépatotoxicité de l'acétate de cyprotérone" [Hepatotoxicity of cyproterone acetate]. Rev Med Interne (in French). 13 (3): 245. doi:10.1016/S0248-8663(05)81339-6. PMID 1410910.
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- ^ Bressollette L, Dubois A, Carlhant D, Morand C, Mottier D, Riche C (1994). "Hépatite mortelle a l'acétate de cyprotérone" [Fatal hepatitis caused by cyproterone acetate]. Therapie (in French). 49 (2): 153. PMID 7817350.
- ^ Hirsch D, Kovatz S, Bernheim J, Shenkman L (March 1994). "Fatal fulminant hepatitis from cyproterone acetate". Isr. J. Med. Sci. 30 (3): 238–40. PMID 8181926.
- ^ Kattan J, Spatz A, Culine S, Terrier-Lacombe MJ, Elias D, Droz JP (October 1994). "Hepatocellular carcinoma during hormonotherapy for prostatic cancer". Am. J. Clin. Oncol. 17 (5): 390–2. doi:10.1097/00000421-199410000-00006. PMID 8092108. S2CID 20317818.
- ^ a b c Watanabe S, Yamasaki S, Tanae A, Hibi I, Honna T (December 1994). "Three cases of hepatocellular carcinoma among cyproterone users. Ad hoc Committee on Androcur Users". Lancet. 344 (8936): 1567–8. doi:10.1016/S0140-6736(94)90373-5. PMID 7983963. S2CID 45906662.
- ^ a b c d e Watanabe S, Cui Y, Tanae A, Tanaka T, Fujimoto M, Matsuo Y, Tachibana K, Yamasaki S (September 1997). "Follow-up study of children with precocious puberty treated with cyproterone acetate. Ad hoc Committee for CPA". J Epidemiol. 7 (3): 173–8. doi:10.2188/jea.7.173. PMID 9337516. S2CID 71680776.
- ^ a b Pinganaud G, Chaslerie A, Bourdel Marchasson I, Decamps A, Manciet G, Emeriau JP (June 1995). "Cyproterone-induced hepatotoxicity". Ann Pharmacother. 29 (6): 634. doi:10.1177/106002809502900619. PMID 7663042. S2CID 1656405.
- ^ Rüdiger T, Beckmann J, Queisser W (February 1995). "Hepatocellular carcinoma after treatment with cyproterone acetate combined with ethinyloestradiol". Lancet. 345 (8947): 452–3. doi:10.1016/S0140-6736(95)90434-4. PMID 7853970. S2CID 28658581.
- ^ Castellani P, Bernardini D, Renou C, Zamora C, Portal I, Gauthier A, Botta-Fridlund D (1996). "Hépatite subfulminante mortelle à l'acétate de cyprotérone. Un nouveau cas" [Fatal sub-fulminant hepatitis caused by cyproterone acetate. A new case]. Gastroenterol. Clin. Biol. (in French). 20 (10): 915–6. ISSN 0399-8320. PMID 8991155.
- ^ Murphy BJ, Collins BJ (October 1996). "Severe hepatitis and liver failure induced by cyproterone acetate". Aust N Z J Med. 26 (5): 724. doi:10.1111/j.1445-5994.1996.tb02956.x. PMID 8958378.
- ^ Ruiz-Rebollo ML, Polo F, Palenzuela R, Moretó M (1997). "Hepatitis aguda severa por ciproterona" [Severe acute hepatitis due to cyproterone]. Gastroenterol Hepatol (in Spanish). 20 (7): 385. ISSN 0210-5705. PMID 9377242.
- ^ Lombardi A, Ferrazza P, Castaldi F, Covotta L, Tesoriere A, Urbano V, Midiri G (April 1998). "Necrosi epatica acuta in paziente sottoposto a terapia con ciproterone acetato" [Acute hepatic necrosis in a patient treated with cyproterone acetate]. G Chir (in Italian). 19 (4): 161–3. PMID 9628065.
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- ^ Garty BZ, Dinari G, Gellvan A, Kauli R (May 1999). "Cirrhosis in a child with hypothalamic syndrome and central precocious puberty treated with cyproterone acetate". Eur. J. Pediatr. 158 (5): 367–70. doi:10.1007/s004310051093. PMID 10333116. S2CID 2736489.
- ^ Manfredi S, Lenfant L, Gresset AC, Bonnotte B, Lorcerie B, Chauffert B (November 2000). "Carcinome hépatocellulaire sur foie sain potentiellement imputable à la prise au long cours d'acétate de cyprotérone" [Hepatocellular carcinoma in a healthy liver possibly due to long-term use of cyproterone acetate]. Presse Med (in French). 29 (36): 1983. ISSN 0755-4982. PMID 11149080.
- ^ Giordano N, Nardi P, Santacroce C, Geraci S, Gennari C (September 2001). "Acute hepatitis induced by cyproterone acetate". Ann Pharmacother. 35 (9): 1053–5. doi:10.1177/106002800103500902. PMID 11573856. S2CID 45449852.
- ^ Kacar S, Akdogan M, Koşar Y, Parlak E, Sasmaz N, Oguz P, Aydog G (July 2002). "Estrogen and cyproterone acetate combination-induced autoimmune hepatitis". J. Clin. Gastroenterol. 35 (1): 98–100. doi:10.1097/00004836-200207000-00023. PMID 12080237.
- ^ Manolakopoulos S, Bethanis S, Armonis A, Economou M, Avgerinos A, Tzourmakliotis D (March 2004). "Toxic hepatitis after sequential administration of flutamide and cyproterone acetate". Dig. Dis. Sci. 49 (3): 462–5. doi:10.1023/B:DDAS.0000020504.41500.9c. PMID 15139499. S2CID 42497536.
- ^ Famularo G, Minisola G, Grieco A, Miele L (September 2005). "Fulminant liver failure caused by cyproterone". Dig Liver Dis. 37 (9): 718–9. doi:10.1016/j.dld.2005.04.018. PMID 15936995.
- ^ a b c d Savidou I, Deutsch M, Soultati AS, Koudouras D, Kafiri G, Dourakis SP (December 2006). "Hepatotoxicity induced by cyproterone acetate: a report of three cases". World J. Gastroenterol. 12 (46): 7551–5. doi:10.3748/wjg.v12.i46.7551. PMC 4087608. PMID 17167851.
- ^ Miquel M, Soler A, Vaqué A, Ojanguren I, Costa J, Planas R (October 2007). "Suspected cross-hepatotoxicity of flutamide and cyproterone acetate". Liver Int. 27 (8): 1144–7. doi:10.1111/j.1478-3231.2007.01549.x. PMID 17845544. S2CID 23120975.
- ^ a b He JC, Xu P, Peng LB (December 2009). "炔雌醇环丙孕酮致布加综合征1例" [A case of Budd-Chiari syndrome induced by ethinylestradiol and cyproterone acetate]. Zhonghua Gan Zang Bing Za Zhi (in Chinese). 17 (12): 954. doi:10.3760/cma.j.issn.1007-3418.2009.12.020. ISSN 1007-3418. PMID 20038345.
- ^ "Ethinylestradiol/cyproterone. Budd-Chiari syndrome: case report". Reactions Weekly (1340): 20. February 2011. doi:10.2165/00128415-201113400-00066. ISSN 0114-9954.
- ^ Kim BH, Kim DJ, Sohn KM, Yang HN, Choi MJ, Lee CW, Choi KC (2009). "잠복간경변 환자에서 cyproterone acetate에 의해 발생한 전격간부전 1예" [A case of fulminant hepatic failure due to cyproterone acetate in a patient with cryptogenic liver cirrhosis]. Korean J Med. 77 (Suppl 1): S31-5. ISSN 1738-9364.
- ^ Hsu YC, Tai DI (2011). "Unusually high alanine aminotransferase to aspartate aminotransferase ratio in a patient with cyproterone-induced icteric hepatitis". Chang Gung Med J. 34 (6 Suppl): 34–8. PMID 22490456.
- ^ Abenavoli L, Milic N, Beaugrand M (2013). "Severe hepatitis induced by cyproterone acetate: role of corticosteroids. A case report". Ann Hepatol. 12 (1): 152–5. doi:10.1016/S1665-2681(19)31399-7. PMID 23293208.
- ^ Vodička M, Sálek T, Röderová E, Cerný D (2013). "Hepatotoxicita po cyproteron acetátu v léčbě karcinomu prostaty – kazuistika" [Hepatotoxicity induced by cyproterone acetate in the prostate carcinoma treatment - a case report]. Klin Onkol (in Czech). 26 (1): 47–8. doi:10.14735/amko201347. PMID 23528173.
- ^ Kim JH, Yoo BW, Yang WJ (May 2014). "Hepatic failure induced by cyproterone acetate: A case report and literature review". Can Urol Assoc J. 8 (5–6): E458–61. doi:10.5489/cuaj.1753. PMC 4081269. PMID 25024808.
- ^ a b c d e f g h i j k l m n o p q r s t u v w Bessone F, Lucena MI, Roma MG, Stephens C, Medina-Cáliz I, Frider B, Tsariktsian G, Hernández N, Bruguera M, Gualano G, Fassio E, Montero J, Reggiardo MV, Ferretti S, Colombato L, Tanno F, Ferrer J, Zeno L, Tanno H, Andrade RJ (February 2016). "Cyproterone acetate induces a wide spectrum of acute liver damage including corticosteroid-responsive hepatitis: report of 22 cases". Liver Int. 36 (2): 302–10. doi:10.1111/liv.12899. PMID 26104271. S2CID 33393791.
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- ^ Kumar P, Reddy S, Kulkarni A, Sharma M, Rao PN (2021). "Cyproterone Acetate-Induced Acute Liver Failure: A Case Report and Review of the Literature". J Clin Exp Hepatol. 11 (6): 739–741. doi:10.1016/j.jceh.2021.01.003. PMC 8617532. PMID 34866850.
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Recently, a publication of the Medicines Control Agency (MCA)/Committee on Safety of Medicines (CSM)[5] drew attention to spontaneous reports of serious and dose-related hepatic toxicity after the prolonged use of CPA. [...] 96 hepatotoxic events (33 fatal) have been observed, of which 91 were in males and 5 in females. The hepatic reactions included hepatitis, cholestatic jaundice and hepatic failure. The majority of patients were treated with high dosages of CPA (300 mg/day) for cancer of the prostate.
- ^ "Hepatic reactions with cyproterone acetate (Cyprostat, Androcur)". Current Problems in Pharmacovigilance (21): 1. February 1995.
- ^ "High dose cyproterone and hepatotoxicity". Australian Adverse Drug Reactions Bulletin. 23 (1): 3. 2004. ISSN 1325-8540.
High dose cyproterone (50mg, 100mg; Androcur, Androcur-100) is used predominantly for advanced prostate carcinoma. For the year ending June 2003, 59,000 prescriptions were dispensed for the 50mg or 100mg tablets and 97% of patients prescribed these tablets were male. [...] Over the years, ADRAC has received 105 reports implicating high-dose cyproterone. The most common adverse reactions are related to the liver with 32 reports. Other more commonly reported reactions include fatigue, dyspnoea, asthenia, confusion, depression and deep vein thrombosis. [...] All except one of the hepatic reactions involved male patients being treated for prostate cancer, whose ages ranged from 56 to 92 (median: 77) years. Time to onset of liver dysfunction ranged from 4 days to 4 years (median: 4-5 months); only 4 cases had a time to onset under a month.
- ^ Manso G, Thole Z, Salgueiro E, Revuelta P, Hidalgo A (April 2006). "Spontaneous reporting of hepatotoxicity associated with antiandrogens: data from the Spanish pharmacovigilance system". Pharmacoepidemiol Drug Saf. 15 (4): 253–9. doi:10.1002/pds.1168. PMID 16294367. S2CID 24515447.
- ^ a b Heinemann LA, Will-Shahab L, van Kesteren P, Gooren LJ (May 1997). "Safety of cyproterone acetate: report of active surveillance". Pharmacoepidemiol Drug Saf. 6 (3): 169–78. doi:10.1002/(SICI)1099-1557(199705)6:3<169::AID-PDS263>3.0.CO;2-3. PMID 15073785. S2CID 24781052.
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