# 11 - References

# References

Prescribing in hepatic and renal impairment
CHAPTER 8
References
1. Slim M, et al. Hepatic safety of atypical antipsychotics: current evidence and future directions. Drug Saf 2016; 39:925–943.
2. Todorović Vukotić N, et al. Antidepressants-­ and antipsychotics-­induced hepatotoxicity. Arch Toxicol 2021; 95:767–789.
3. Marwick KF, et al. Antipsychotics and abnormal liver function tests: systematic review. Clin Neuropharmacol 2012; 35:244–253.
4. Morlán-­Coarasa MJ, et al. Incidence of non-­alcoholic fatty liver disease and metabolic dysfunction in first episode schizophrenia and related 
psychotic disorders: a 3-­year prospective randomized interventional study. Psychopharmacology (Berl) 2016; 233:3947–3952.
5. Baeza I, et al. One-­year prospective study of liver function tests in children and adolescents on second-­generation antipsychotics: is there a 
link with metabolic syndrome? J Child Adolesc Psychopharmacol 2018; 28:463–473.
6. Datapharm Communications Ltd. Electronic Medicines Compendium. 2023; https://www.medicines.org.uk/emc.
7. IBM Watson Health. IBM Micromedex Solutions. 2024; https://www.ibm.com/watson-­health/about/micromedex.
8. Zeiss R, et al. Drug-­associated liver injury related to antipsychotics: exploratory analysis of pharmacovigilance data. J Clin Psychopharmacol 
2022; 42:440–444.
9. Nikogosyan G, et al. Acute aripiprazole-­associated liver injury. J Clin Psychopharmacol 2021; 41:344–346.
10. Mallikaarjun S, et al. Effects of hepatic or renal impairment on the pharmacokinetics of aripiprazole. Clin Pharmacokinet 2008; 47:533–542.
11. Preskorn SH. Clinically important differences in the pharmacokinetics of the ten newer ‘atypical’ antipsychotics: Part 3. Effects of renal and 
hepatic impairment. J Psychiatr Pract 2012; 18:430–437.
12. Chico G, et al. Clinical vignettes 482 aripiprazole causes cholelithiasis and hepatitis: a rare finding. Am J Gastroenterol 2005; 100:S164.
13. Kornischka J, et al. Acute drug-­induced hepatitis during aripiprazole monotherapy: a case report. J Pharmacovigil 2016; 4:1000201.
14. Castanheira L, et al. Aripiprazole-­induced hepatitis: a case report. Clin Psychopharmacol Neurosci 2019; 17:551–555.
15. Peeters P, et al. Asenapine pharmacokinetics in hepatic and renal impairment. Clin Pharmacokinet 2011; 50:471–481.
16. Schultz K, et al. A case of pseudo-­Stauffer’s syndrome related to asenapine use. Schizophr Res 2015; 169:500–501.
17. Parikh NB, et al. Clinical role of brexpiprazole in depression and schizophrenia. Ther Clin Risk Manag 2017; 13:299–306.
18. Cutler AJ, et al. Evaluation of the long-­term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-­year 
­open-­label study. CNS Spectr 2018; 23:39–50.
19. Brown CA, et al. Clozapine toxicity and hepatitis. J Clin Psychopharmacol 2013; 33:570–571.
20. Tucker P. Liver toxicity with clozapine. Aust NZ J Psychiatry 2013; 47:975–976.
21. Gaertner HJ, et al. Side effects of clozapine. Psychopharmacology (Berl) 1989; 99 Suppl:S97–100.
22. Lally J, et al. Hepatitis, interstitial nephritis, and pancreatitis in association with clozapine treatment: a systematic review of case series and 
reports. J Clin Psychopharmacol 2018; 38:520–527.
23. Takács A, et al. Clozapine rechallenge in a patient with clozapine-­induced hepatitis. Australas Psychiatry 2019; 27:535.
24. Amdisen A, et al. Zuclopenthixol acetate in viscoleo – a new drug formulation. An open Nordic multicentre study of zuclopenthixol acetate 
in Viscoleo in patients with acute psychoses including mania and exacerbation of chronic psychoses. Acta Psychiatr Scand 1987; 
75:99–107.
25. Wistedt B, et al. Zuclopenthixol decanoate and haloperidol decanoate in chronic schizophrenia: a double-­blind multicentre study. Acta 
Psychiatr Scand 1991; 84:14–21.
26. Demuth N, et al. [Flupentixol-­induced acute hepatitis]. Gastroenterol Clin Biol 1999; 23:152–153.
27. Nolen WA, et  al. Disturbances of liver function of long acting neuroleptic drugs. Pharmakopsychiatr Neuropsychopharmakol 1978; 
11:199–204.
28. LiverTox. Clinical and Research Information on Drug-­induced Liver Injury. Bethesda, MD: National Institute of Diabetes and Digestive and 
Kidney Diseases; 2012.
29. Vanda Pharmaceuticals Inc. FANAPT® (iloperidone) tablets 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, 12mg indication and important safety information. 2021; http://www.fanapt.com/product/pi/pdf/fanapt.pdf.
30. US Food and Drug Administration. Drugs@FDA: FDA-­approved drugs. 2023; https://www.accessdata.fda.gov/scripts/cder/daf.
31. Greenwood J, et al. Lumateperone: a novel antipsychotic for schizophrenia. Ann Pharmacother 2021; 55:98–104.
32. Druschky K, et al. Severe drug-­induced liver injury in patients under treatment with antipsychotic drugs: data from the AMSP study. World 
J Biol Psychiatry 2021; 22:373–386.
33. Gunther M, et al. Antipsychotic safety in liver disease: a narrative review and practical guide for the clinician. J Acad Consult Liaison 
Psychiatry 2023; 64:73–82.
34. Amatniek J, et al. Safety of paliperidone extended-­release in patients with schizophrenia or schizoaffective disorder and hepatic disease. Clin 
Schizophr Relat Psychoses 2014; 8:8–20.
35. Macaluso M, et al. Pharmacokinetic drug evaluation of paliperidone in the treatment of schizoaffective disorder. Expert Opin Drug Metab 
Toxicol 2017; 13:871–879.
36. Chang CH, et al. Paliperidone is associated with reduced risk of severe hepatic outcome in patients with schizophrenia and viral hepatitis: a 
nationwide population-­based cohort study. Psychiatry Res 2019; 281:112597.
37. Vats A, et al. Treatment of patients with schizophrenia and comorbid chronic hepatitis with paliperidone: a systematic review. Cureus 2023; 
15:e34234.
38. Braude MR, et al. Liver disease prevalence and severity in people with serious mental illness: a cross-­sectional analysis using non-­invasive 
diagnostic tools. Hepatol Int 2021; 15:812–820.
39. Khorassani F, et al. Risperidone-­ and paliperidone-­induced hepatotoxicity: case report and review of literature. Am J Health Syst Pharm 
2020; 77:1578–1584.
40. Das A, et al. Liver injury associated with quetiapine: an illustrative case report. J Clin Psychopharmacol 2017; 37:623–625.

764
The Maudsley® Prescribing Guidelines in Psychiatry
CHAPTER 8
41. Ko S, et al. Investigation of hepatic adverse events due to quetiapine by using the common data model. Pharmacoepidemiol Drug Saf 2023; 
32:1341–1349.
42. Monnelly EP, et al. Quetiapine for treatment of alcohol dependence. J Clin Psychopharmacol 2004; 24:532–535.
43. Brown ES, et al. A randomized, double-­blind, placebo-­controlled trial of quetiapine in patients with bipolar disorder, mixed or depressed 
phase, and alcohol dependence. Alcohol Clin Exp Res 2014; 38:2113–2118.
44. Vatsalya V, et al. Safety assessment of liver injury with quetiapine fumarate XR management in very heavy drinking alcohol-­dependent 
patients. Clin Drug Investig 2016; 36:935–944.
45. Holtmann M, et al. Risperidone-­associated steatohepatitis and excessive weight-­gain. Pharmacopsychiatry 2003; 36:206–207.
46. Voican CS, et al. Antidepressant-­induced liver injury: a review for clinicians. Am J Psychiatry 2014; 171:404–415.
47. Freiesleben SD, et al. A systematic review of agomelatine-­induced liver injury. J Mol Psychiatry 2015; 3:4.
48. Gahr M, et al. Safety and tolerability of agomelatine: focus on hepatotoxicity. Curr Drug Metab 2014; 15:694–702.
49. Billioti de Gage S, et al. Antidepressants and hepatotoxicity: a cohort study among 5 million individuals registered in the French National 
Health Insurance Database. CNS Drugs 2018; 32:673–684.
50. Pladevall-­Vila M, et al. Risk of acute liver injury in agomelatine and other antidepressant users in four European countries: a cohort and 
nested case-­control study using automated health data sources. CNS Drugs 2019; 33:383–395.
51. Lundbeck Limited. Summary of product characteristics. Citalopram 20mg film-­coated tablets. 2023; https://www.medicines.org.uk/emc/
product/992/smpc.
52. Lopez-­Torres E, et al. Hepatotoxicity related to citalopram (Letter). Am J Psychiatry 2004; 161:923–924.
53. Hanje AJ, et al. Case report: fulminant hepatic failure involving duloxetine hydrochloride. Clin Gastroenterol Hepatol 2006; 4:912–917.
54. Vuppalanchi R, et al. Duloxetine hepatotoxicity: a case-­series from the drug-­induced liver injury network. Aliment Pharmacol Ther 2010; 
32:1174–1183.
55. Lin ND, et  al. Hepatic outcomes among adults taking duloxetine: a retrospective cohort study in a US health care claims database. 
BMC Gastroenterol 2015; 15:134.
56. McIntyre RS, et al. The hepatic safety profile of duloxetine: a review. Expert Opin Drug Metab Toxicol 2008; 4:281–285.
57. Bunchorntavakul C, et al. Drug hepatotoxicity: newer agents. Clin Liver Dis 2017; 21:115–134.
58. Lundbeck Limited. Summary of product characteristics. Escitalopram 10mg film-­coated tablets. 2023; https://www.medicines.org.uk/emc/
product/7718/smpc.
59. Rao N. The clinical pharmacokinetics of escitalopram. Clin Pharmacokinet 2007; 46:281–290.
60. Schenker S, et al. Fluoxetine disposition and elimination in cirrhosis. Clin Pharmacol Ther 1988; 44:353–359.
61. Cai Q, et al. Acute hepatitis due to fluoxetine therapy. Mayo Clin Proc 1999; 74:692–694.
62. Friedenberg FK, et al. Hepatitis secondary to fluoxetine treatment. Am J Psychiatry 1996; 153:580.
63. Johnston DE, et al. Chronic hepatitis related to use of fluoxetine. Am J Gastroenterol 1997; 92:1225–1226.
64. Hale AS. New antidepressants: use in high-­risk patients. J Clin Psychiatry 1993; 54 Suppl:61–70.
65. Mylan. Summary of product characteristics. Fluvoxamine 100mg film-­coated tablets. 2023; https://www.medicines.org.uk/emc/­product/6603/
smpc.
66. Stoeckel K, et al. Absorption and disposition of moclobemide in patients with advanced age or reduced liver or kidney function. Acta Psychiatr 
Scand Suppl 1990; 360:94–97.
67. Mylan Specialty LP. Highlights of prescribing information. EMSAM® (selegiline transdermal system) 2014; https://www.accessdata.fda.gov/
drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf.
68. Thomas E, et al. Mirtazapine-­induced steatosis. Int J Clin Pharmacol Ther 2017; 55:630–632.
69. Shaheen AA, et al. The impact of depression and antidepressant usage on primary biliary cholangitis clinical outcomes. PLoS One 2018; 
13:e0194839.
70. Sandoz Limited. Summary of product characteristics. Paroxetine 20mg tablets. 2024; https://www.medicines.org.uk/emc/product/4168/smpc.
71. Colakoglu O, et al. Toxic hepatitis associated with paroxetine. Int J Clin Pract 2005; 59:861–862.
72. Düll MM, et al. Evaluation and management of pruritus in primary biliary cholangitis. Clin Liver Dis 2022; 26:727–745.
73. Tran A, et al. Pharmacokinetics of reboxetine in volunteers with hepatic impairment. Clin Drug Investig 2000; 19:473–477.
74. Mylan. Summary of product characteristics. Setraline 100mg tablets. 2023; https://www.medicines.org.uk/emc/product/10586/smpc.
75. Committee on Safety of Medicines. Lofepramine (Gamanil) and abnormal blood tests of liver function. Curr Problems 1988; 23:371.
76. Archer DF, et al. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause 2013; 20:47–56.
77. Baird-­Bellaire S, et al. An open-­label, single-­dose, parallel-­group study of the effects of chronic hepatic impairment on the safety and pharmacokinetics of desvenlafaxine. Clin Ther 2013; 35:782–794.
78. Ryan PB, et al. Atypical antipsychotics and the risks of acute kidney injury and related outcomes among older adults: a replication analysis 
and an evaluation of adapted confounding control strategies. Drugs Aging 2017; 34:211–219.
79. Chen G, et al. Vortioxetine: clinical pharmacokinetics and drug interactions. Clin Pharmacokinet 2018; 57:673–686.
80. Bjornsson E. Hepatotoxicity associated with antiepileptic drugs. Acta Neurol Scand 2008; 118:281–290.
81. Guo HL, et al. Valproic acid and the liver injury in patients with epilepsy: an update. Curr Pharm Des 2019; 25:343–351.
82. Panei P, et al. Safety of psychotropic drug prescribed for attention-­deficit/hyperactivity disorder in Italy. Adv Drug Reaction Bull 2010; 
260:999–1002.
83. Reed VA, et al. The safety of atomoxetine for the treatment of children and adolescents with attention-­deficit/hyperactivity disorder: a 
­comprehensive review of over a decade of research. CNS Drugs 2016; 30:603–628.

Prescribing in hepatic and renal impairment
CHAPTER 8
84. Shire Pharmaceuticals Limited. Summary of product characteristics. Elvanse 20mg, 30mg, 40mg, 50mg, 60mg, 70mg hard capsules. 2023; 
https://www.medicines.org.uk/emc/search?q=%22Elvanse%22.
85. Medice UK Ltd. Summary of product characteristics. Amfexa 5mg, 10mg, 20mg tablets. 2023; https://www.medicines.org.uk/emc/
search?q=amfexa.
86. Vanga RR, et al. Adderall induced acute liver injury: a rare case and review of the literature. Case Rep Gastrointest Med 2013; 2013:902892.
87. Hood B, et  al. Eosinophilic hepatitis in an adolescent during lisdexamfetamine dimesylate treatment for ADHD. Pediatrics 2010; 
125:e1510–1513.
88. Tong HY, et al. Liver transplant in a patient under methylphenidate therapy: a case report and review of the literature. Case Rep Pediatr 
2015; 2015:437298.
89. Flynn Pharma Ltd. Summary of product characteristics. Circadin 2mg prolonged-­release tablets. 2021; https://www.medicines.org.uk/emc/
product/2809/smpc.
90. SANOFI. Summary of product characteristics. Zimovane 7.5mg and 3.75mg LS film-­coated tablets. 2023; https://www.medicines.org.uk/
emc/product/2855/smpc.
91. Zentiva. Summary of product characteristics. Zolpidem tartrate 5mg, 10mg tablets. 2021; https://www.medicines.org.uk/emc/
search?q=zolpidem.
92. Gunja N. The clinical and forensic toxicology of Z-­drugs. J Med Toxicol 2013; 9:155–162.
93. Wu T, et al. Case report of acute liver injury caused by the eszopiclone in a patient with chronic liver disease. Medicine (Baltimore) 2021; 
100:e26243.
94. Jackson CD, et al. Hold the gaba: a case of gabapentin-­induced hepatotoxicity. Cureus 2018; 10:e2269.
95. Chahal J, et al. Gabapentin-­induced liver toxicity. Am J Ther 2022; 29:e751–e752.
96. Kärppä M, et al. Long-­term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from 
the phase 3 randomized clinical trial SUNRISE 2. Sleep 2020; 43:zsaa123.
97. Upjohn UK Limited. Summary of product characteristics. Lyrica (pregabalin) 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg 
capsules. 2024; https://www.medicines.org.uk/emc/product/10303/smpc.
98. Sendra JM, et al. Pregabalin-­induced hepatotoxicity. Ann Pharmacother 2011; 45:e32.
99. Düzenli T, et al. Pregabaline as a rare cause of hepatotoxicity. Pain Med 2017; 18:1407–1408.
100. Grattagliano I, et  al. Biochemical mechanisms in drug-­induced liver injury: certainties and doubts. World J Gastroenterol 2009; 
15:4865–4876.
101. Rosalki SB, et al. Liver function profiles and their interpretation. Br J Hosp Med 1994; 51:181–186.
102. Rettenbacher MA, et al. Association between antipsychotic-­induced elevation of liver enzymes and weight gain: a prospective study. J Clin 
Psychopharmacol 2006; 26:500–503.