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Saini J, Marino D, Badalov N, Vugelman M, Tenner S. Drug-Induced Acute Pancreatitis: An Evidence-Based Classification (Revised). Clin Transl Gastroenterol 2023; 14:e00621. [PMID: 37440319 PMCID: PMC10461957 DOI: 10.14309/ctg.0000000000000621] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2023] [Accepted: 07/06/2023] [Indexed: 07/15/2023] Open
Abstract
INTRODUCTION Drug induced acute pancreatitis is a difficult diagnosis for clinicians. We previously published an "Evidence-Based Classification System" on Drug-Induced Acute Pancreatitis widely used by clinicians to assist in the identification of drugs. Unfortunately, this prior analysis based only on published case reports has been misunderstood. The prior review did not include studies with higher evidentiary value, such as randomized trials, case-control studies, and/or pharmacoepidemiologic studies. The use of the prior classification system has led to many patients being inappropriately labeled as having drug-induced acute pancreatitis. We now propose a "Revised" Evidence- Based Classification System for the purpose of determining which drugs cause acute pancreatitis based on the Grading of Recommendations, Development, and Evaluation criteria. METHODS A search of the English Language literature was performed to identify all case reports with medication and/or drug induced acute pancreatitis. We divided the drugs implicated as causing acute pancreatitis into four groups based on the quality of evidence as defined by GRADE quality parameters. RESULTS Although 141 drugs were identified in the literature as causing acute pancreatitis, only 106 drugs published in the literature as causing acute pancreatitis were high quality case reports. Only 3 drugs had evidence as causing acute pancreatitis from randomized controlled clinical trials, including 6-mercaptopurine and azathioprine. DISCUSSION The vast majority of drugs implicated as causing acute pancreatitis in the literature have low or very low quality of evidence supporting those claims.
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Affiliation(s)
- Jasmine Saini
- Maimonides Medical Center, State University of New York–Downstate Medical Center, Brooklyn, New York, USA
| | - Daniel Marino
- Maimonides Medical Center, State University of New York–Downstate Medical Center, Brooklyn, New York, USA
| | - Nison Badalov
- Maimonides Medical Center, State University of New York–Downstate Medical Center, Brooklyn, New York, USA
| | - Melanie Vugelman
- Maimonides Medical Center, State University of New York–Downstate Medical Center, Brooklyn, New York, USA
| | - Scott Tenner
- Maimonides Medical Center, State University of New York–Downstate Medical Center, Brooklyn, New York, USA
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Khorassani F, Sousonis F, Lopez LV. Risperidone- and paliperidone-induced hepatotoxicity: Case report and review of literature. Am J Health Syst Pharm 2020; 77:1578-1584. [DOI: 10.1093/ajhp/zxaa224] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Abstract
Abstract
Purpose
A case of hepatotoxicity likely due to use of risperidone and paliperidone is reported.
Summary
A 23-year-old man with schizophrenia was admitted to an inpatient psychiatric unit after an exacerbation of mental illness secondary to medication nonadherence. During 13 days of treatment with risperidone, the patient’s liver enzyme levels rose sharply, so antipsychotic therapy was switched to oral paliperidone. After a 5-day downward trend in liver enzyme levels, a dose of intramuscular paliperidone was administered to augment oral paliperidone therapy. After 10 days of paliperidone use, abnormally high liver enzyme levels were again noted; both oral and intramuscular paliperidone therapy were discontinued and haloperidol was initiated, with complete resolution of liver enzyme abnormalities within approximately 4 weeks. Scoring of this case using the algorithm of Naranjo et al indicated probable associations between risperidone use and hepatotoxicity (a score of 7) and paliperidone use and hepatotoxicity (a score of 8). To our knowledge, this is the first case report describing a patient who developed hepatotoxicity during risperidone use that did not remit with a switch to paliperidone therapy.
Conclusion
Findings of this case suggest that patients who develop hepatotoxicity with use of risperidone may also do so with paliperidone use; this, in turn, suggests that both risperidone and its metabolite are capable of causing hepatotoxicity. Patients who develop hepatotoxicity in response to risperidone or paliperidone therapy may benefit from treatment with an alternative antipsychotic with a different chemical structure.
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Affiliation(s)
- Farah Khorassani
- Department of Clinical Health Professions, St. John’s University College of Pharmacy and Health Sciences, Queens, NY, and Department of Pharmacy, Bellevue Hospital Center, New York, NY
| | - Frances Sousonis
- College of Pharmacy and Health Sciences, St. John’s University, Queens, NY, and Bristol-Myers Squibb, Lawrenceville, NJ
| | - Leonardo V Lopez
- Department of Psychiatry, Bellevue Hospital Center, New York, NY, and Department of Psychiatry, NYU School of Medicine, New York, NY
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Wolfe D, Kanji S, Yazdi F, Barbeau P, Rice D, Beck A, Butler C, Esmaeilisaraji L, Skidmore B, Moher D, Hutton B. Drug induced pancreatitis: A systematic review of case reports to determine potential drug associations. PLoS One 2020; 15:e0231883. [PMID: 32302358 PMCID: PMC7164626 DOI: 10.1371/journal.pone.0231883] [Citation(s) in RCA: 57] [Impact Index Per Article: 11.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2020] [Accepted: 04/02/2020] [Indexed: 12/12/2022] Open
Abstract
OBJECTIVE A current assessment of case reports of possible drug-induced pancreatitis is needed. We systematically reviewed the case report literature to identify drugs with potential associations with acute pancreatitis and the burden of evidence supporting these associations. METHODS A protocol was developed a priori (PROSPERO CRD42017060473). We searched MEDLINE, Embase, the Cochrane Library, and additional sources to identify cases of drug-induced pancreatitis that met accepted diagnostic criteria of acute pancreatitis. Cases caused by multiple drugs or combination therapy were excluded. Established systematic review methods were used for screening and data extraction. A classification system for associated drugs was developed a priori based upon the number of cases, re-challenge, exclusion of non-drug causes of acute pancreatitis, and consistency of latency. RESULTS Seven-hundred and thirteen cases of potential drug-induced pancreatitis were identified, implicating 213 unique drugs. The evidence base was poor: exclusion of non-drug causes of acute pancreatitis was incomplete or poorly reported in all cases, 47% had at least one underlying condition predisposing to acute pancreatitis, and causality assessment was not conducted in 81%. Forty-five drugs (21%) were classified as having the highest level of evidence regarding their association with acute pancreatitis; causality was deemed to be probable or definite for 19 of these drugs (42%). Fifty-seven drugs (27%) had the lowest level of evidence regarding an association with acute pancreatitis, being implicated in single case reports, without exclusion of other causes of acute pancreatitis. DISCUSSION Much of the case report evidence upon which drug-induced pancreatitis associations are based is tenuous. A greater emphasis on exclusion of all non-drug causes of acute pancreatitis and on quality reporting would improve the evidence base. It should be recognized that reviews of case reports, are valuable scoping tools but have limited strength to establish drug-induced pancreatitis associations. REGISTRATION CRD42017060473.
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Affiliation(s)
- Dianna Wolfe
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Salmaan Kanji
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Department of Pharmacy, The Ottawa Hospital, Ottawa, Ontario, Canada
| | - Fatemeh Yazdi
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Pauline Barbeau
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Danielle Rice
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Andrew Beck
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Claire Butler
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Leila Esmaeilisaraji
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Becky Skidmore
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - David Moher
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Brian Hutton
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada
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Telles-Correia D, Barbosa A, Cortez-Pinto H, Campos C, Rocha NBF, Machado S. Psychotropic drugs and liver disease: A critical review of pharmacokinetics and liver toxicity. World J Gastrointest Pharmacol Ther 2017; 8:26-38. [PMID: 28217372 PMCID: PMC5292604 DOI: 10.4292/wjgpt.v8.i1.26] [Citation(s) in RCA: 68] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2016] [Revised: 11/02/2016] [Accepted: 11/16/2016] [Indexed: 02/06/2023] Open
Abstract
The liver is the organ by which the majority of substances are metabolized, including psychotropic drugs. There are several pharmacokinetic changes in end-stage liver disease that can interfere with the metabolization of psychotropic drugs. This fact is particularly true in drugs with extensive first-pass metabolism, highly protein bound drugs and drugs depending on phase I hepatic metabolic reactions. Psychopharmacological agents are also associated with a risk of hepatotoxicity. The evidence is insufficient for definite conclusions regarding the prevalence and severity of psychiatric drug-induced liver injury. High-risk psychotropics are not advised when there is pre-existing liver disease, and after starting a psychotropic agent in a patient with hepatic impairment, frequent liver function/lesion monitoring is advised. The authors carefully review the pharmacokinetic disturbances induced by end-stage liver disease and the potential of psychopharmacological agents for liver toxicity.
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Acute Pancreatitis Associated With Antipsychotic Medication: Evaluation of Clinical Features, Treatment, and Polypharmacy in a Series of Cases. J Clin Psychopharmacol 2016; 36:169-72. [PMID: 26859276 DOI: 10.1097/jcp.0000000000000459] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
BACKGROUND Antipsychotic-associated acute pancreatitis presents like pancreatitis from other causes, requiring clinical judgment, tests, and decision support to establish the diagnosis. Many new cases of atypical antipsychotic pancreatitis have been established, and current decision supports are out of date as antipsychotic polypharmacy is being recognized. Given the population frequency of psychosis and frequency of antipsychotic prescribing, we reviewed published cases summarizing common clinical findings and antipsychotics associated with acute pancreatitis to updating earlier decision support. METHODS Case reports of antipsychotic pancreatitis from 1990 to 2015 were reviewed and abstracted by independent reviewers. Demographic, clinical features, management, and Naranjo and probability scores were abstracted and reviewed for associations. Appropriate statistical tests were selected for normally and non-normally distributed data. RESULTS We summarized 41 cases of acute pancreatitis associated with antipsychotics, and cases were younger men (59%) (mean age, 39 years). Alcohol, diabetes, and previous lithiasis appeared in 27%; polypharmacy was associated with 53% of cases, and 80% had concomitant use of other medication linked to pancreatitis.The median lipase, amylase, and alkaline phosphate during acute presentation were 1210 IU/L (range, 243-5482 IU/L), 492 IU/L (range, 3-2916 IU/L), and 152 IU/L (range, 119-367 IU/L), respectively. Median exposure to antipsychotics were 49 days (range, 5-3,650 days); most were mild (63%, n = 26), several severe (27%, n = 11), and few fatal (10%, n = 4). DISCUSSION We identified 41 reports of antipsychotic-related acute pancreatitis, many associated with antipsychotic polypharmacy. Olanzapine, risperidone, quetiapine, aripiprazole, and ziprasidone are associated with acute pancreatitis and often in combination with mood stabilizers.
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Kawabe K, Ueno SI. A case of acute pancreatitis associated with risperidone treatment. CLINICAL PSYCHOPHARMACOLOGY AND NEUROSCIENCE 2014; 12:67-8. [PMID: 24851124 PMCID: PMC4022769 DOI: 10.9758/cpn.2014.12.1.67] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/31/2013] [Revised: 09/03/2013] [Accepted: 09/11/2013] [Indexed: 11/18/2022]
Abstract
Acute pancreatitis with antipsychotic treatment is rare but sometimes causes a fatal adverse effect. Most cases of acute pancreatitis due to atypical antipsychotic agents are reported to occur within six months of starting antipsychotic administration. Acute pancreatitis caused by risperidone is rare. The patient had a high fever, stomachache and vomiting. The results of the abdominal computed tomograhpy scan were negative. The results of the abdominal ultrasonography were positive for gallstones in gallbladder and distention of the common bile duct. She had been fasting and received antibiotic intravenous injections. Amylase and lipase titers were high. After risperidone discontinuation, both the levels of the amylase and the lipase were gradually decreased. Three months later, the patient still maintains a good clinical balance. Although atypical antipsychotic-induced pancreatitis has been reported in conjunction with hyperglycemia, the pathophysiologic mechanism of these adverse events remains unclear. This case got pancreatitis 6 month after risperidone treatment. Using the antipsychotic agents, it is necessary to monitor pancreas function.
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Affiliation(s)
- Kentaro Kawabe
- Department of Neuropsychiatry, Graduate School of Medicine, Ehime University, Ehime, Japan
| | - Shu-Ichi Ueno
- Department of Neuropsychiatry, Graduate School of Medicine, Ehime University, Ehime, Japan
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Abstract
OBJECTIVE Systematic assessment of the prevalence and pattern of liver function test (LFT) abnormalities associated with regular antipsychotics in adult humans and consideration of management of such abnormalities. DATA SOURCES Systematic search identifying cohort, cross-sectional or case studies/series, reporting LFT abnormalities in patients receiving regular antipsychotics. EMBASE, PsychINFO, and MEDLINE were searched for studies in English from record onset. STUDY SELECTION Abstracts were independently screened for eligibility by 2 researchers. Ineligible studies included those that did not report LFT reference ranges, those that studied fewer than 10 patients on a given antipsychotic, and those studying children. DATA EXTRACTION Key variables in group studies were extracted. Case studies/series were examined for patient outcome. DATA SYNTHESIS Ten group studies and 91 case studies/series were eligible, although quality was poor. All groups receiving regular antipsychotics had a prevalence of LFT abnormalities greater than chance. The median percentage of patients with any abnormal LFT on any antipsychotic was 32%, with a range of 5% to 78%. The median percentage of patients with clinically significant elevations was 4%, with a range of 0% to 15%. Transaminases were most commonly elevated. Abnormalities were generally asymptomatic, arose within 6 weeks, and were either stably persistent or resolved with continued treatment. Case reports suggested that antipsychotics can be associated with severe hepatitis, fatal in a small minority of cases. Chlorpromazine is most commonly associated with acute liver injury. CONCLUSIONS The LFT abnormalities in patients receiving regular antipsychotics are common but generally mild and transient. Very rarely, a severe or fatal hepatic injury can emerge.
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Bodén R, Bexelius TS, Mattsson F, Lagergren J, Lindblad M, Ljung R. Antidopaminergic drugs and acute pancreatitis: a population-based study. BMJ Open 2012; 2:bmjopen-2012-000914. [PMID: 22581796 PMCID: PMC3353129 DOI: 10.1136/bmjopen-2012-000914] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022] Open
Abstract
OBJECTIVES To evaluate the suggested association between antidopaminergic drugs and acute pancreatitis. DESIGN A large population-based nested case-control study. SETTING Swedish nationwide study from 2006 to 2008. PARTICIPANTS The Patient Register was used to identify 6161 cases of acute pancreatitis. The 61 637 control subjects were randomly selected from the Register of the Total Population by frequency-based density sampling, matched for age, sex and calendar year. EXPOSURE Exposure data were extracted from the Prescribed Drug Register. Antidopaminergic drugs were grouped into antiemetic/anxiolytic and other antipsychotics. Current use of antidopaminergic drugs was defined as filling a prescription 1-114 days before index date, while previous use was 115 days to 3.5 years before index date. MAIN OUTCOME MEASURES Cases were defined as being diagnosed as having acute pancreatitis. ORs and 95% CIs were calculated using unconditional logistic regression. RESULTS The unadjusted OR indicated an increased risk of acute pancreatitis among current users of antiemetic/anxiolytics (OR 1.9, 95% CI 1.4 to 2.6), but not in the multivariable model adjusting for alcohol-related comorbidity, chronic obstructive lung disease, ischaemic heart disease, obesity, diabetes, opioid use, gallstone disease, educational level, marital status and number of concomitant medications (OR 0.9, 95% CI 0.6 to 1.2). Similarly, among current users of other antipsychotics, the unadjusted OR was 1.4 (95% CI 1.1 to 1.6), while the adjusted OR was 0.8 (95% CI 0.6 to 0.9). Results regarding previous use of antidopaminergic drugs followed a similar risk pattern as for current use. CONCLUSIONS The lack of association between antidopaminergic drugs and acute pancreatitis after adjustment for confounding factors in this study suggests that the previously reported positive associations might be explained by confounding.
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Affiliation(s)
- Robert Bodén
- Department of Neuroscience, Unit of Psychiatry, Uppsala University, Uppsala, Sweden
- Centre for Pharmacoepidemiology (CPE), Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden
| | - Tomas S Bexelius
- Upper Gastrointestinal Research, Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
| | - Fredrik Mattsson
- Upper Gastrointestinal Research, Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
| | - Jesper Lagergren
- Upper Gastrointestinal Research, Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
- Division of Cancer Studies, King's College London, London, UK
| | - Mats Lindblad
- Upper Gastrointestinal Research, Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
- Section of Upper Gastrointestinal Surgery, Gastrocenter, Karolinska University Hospital, Stockholm, Sweden
| | - Rickard Ljung
- Upper Gastrointestinal Research, Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
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Risperidone-induced hyperamylasemia, hyperlipasemia, and neuroleptic malignant syndrome: a case report. J Clin Psychopharmacol 2009; 29:391-2. [PMID: 19593182 DOI: 10.1097/jcp.0b013e3181ad2064] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Cordeiro Q, Zung S, Vallada H. Pisa syndrome induced by rapid increase and high dosage of risperidone. ARQUIVOS DE NEURO-PSIQUIATRIA 2008; 66:896-7. [DOI: 10.1590/s0004-282x2008000600026] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
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Halici Z, Keles ON, Unal D, Albayrak M, Suleyman H, Cadirci E, Unal B, Kaplan S. Chronically Administered Risperidone Did Not Change the Number of Hepatocytes in Rats: A Stereological and Histopathological Study. Basic Clin Pharmacol Toxicol 2008; 102:426-32. [DOI: 10.1111/j.1742-7843.2007.00198.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/26/2023]
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Erdogan A, Atasoy N, Akkurt H, Ozturk D, Karaahmet E, Yalug I, Yalug K, Ankarali H, Balcioglu I. Risperidone and liver function tests in children and adolescents: a short-term prospective study. Prog Neuropsychopharmacol Biol Psychiatry 2008; 32:849-57. [PMID: 18258348 DOI: 10.1016/j.pnpbp.2007.12.032] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/09/2007] [Revised: 12/18/2007] [Accepted: 12/26/2007] [Indexed: 01/01/2023]
Abstract
OBJECTIVE Revealing of unknown adverse effects of atypical antipsychotics on pediatric population may take a long period of time. The purpose of this prospective study is to document changes in the liver function tests (LFTs) associated with risperidone usage in a group of children and adolescents. METHOD Study subjects consist of 120 youths with ages ranging from 3-17 years. For this study, patients' baseline and follow-up weight and hepatobiliary function tests including alanine aminotransferases(ALT) and aspartat aminotransferases (AST), gamma gluatamyl transerase (GGT), alkaline phosphatase (ALP) and serum bilirubin levels were measured before and after the treatment period of one month. RESULTS Only one male patient's ALT levels increased up to three-fold and AST levels increased up to two-fold of the basal levels. First month mean levels of liver enzymes and billuribin of the patients were significantly higher than the baseline. Sixty-three patients (52.5%) showed an asymptomatic increase in the liver enzymes and/or billuribin levels of the first month of this study. Weight gain was observed in 58 patients (57.4%). There was no significant association between changes in weight and liver enzymes and billuribin levels. CONCLUSION We found clinically non significant liver function test abnormalities mostly in the form of ALP elevation in 52.5% and marked liver enzymes elevation in 0.8% of risperidone-treated subjects. However use of concomitant medications and variations in age are the limitations of this study. These findings suggest that risperidone treatment in the short term may lead to liver function changes in children and adolescents.
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Affiliation(s)
- Ayten Erdogan
- Department of Child and Adolescent Psychiatry, Zonguldak Karaelmas University, Faculty of Medicine, Zonguldak, Turkey.
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Llinares Tello F, Hernández Prats C, Bosacoma Ros N, Pérez Martínez E, Climent Grana E, Navarro Polo JN, Ordovás Baines JP. Acute cholestatic hepatitis probably associated with risperidone. Int J Psychiatry Med 2006; 35:199-205. [PMID: 16240976 DOI: 10.2190/5xrb-d2xx-x8ah-32kb] [Citation(s) in RCA: 15] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
OBJECTIVE Risperidone is an atypical neuroleptic drug widely used due to the lower incidence and severity of hepatic adverse effects in comparison to phenothiazines. Although idiosyncratic reversible hepatotoxicity may occur in association with risperidone, the interaction with fluoxetine might increase the risk of toxic liver injury in a vulnerable patient. METHODS AND RESULTS We present a case of acute cholestatic hepatitis probably associated with the use of risperidone after only a few days of therapy in a patient also treated with fluoxetine. The patient, a 64-year-old male, developed a rapid increase in liver enzymes after starting treatment with only four doses of risperidone 2 mg/day. CONCLUSIONS We recommend obtaining baseline liver function tests before starting risperidone and regular monitoring to screen patients for liver damage during therapy whenever a patient is also receiving fluoxetine.
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Legaz Huidobro ML, González Carro P, Pérez Roldán F, Soto Fernández S, de Pedro Esteban A, Cuesta Domínguez R. Hepatitis autoinmune tras hepatitis colestásica inducida por risperidona. GASTROENTEROLOGIA Y HEPATOLOGIA 2005; 28:135-6. [PMID: 15771859 DOI: 10.1157/13072013] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/22/2023]
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Gonzalez-Heydrich J, Pandina GJ, Fleisher CA, Hsin O, Raches D, Bourgeois BF, Biederman J. No seizure exacerbation from risperidone in youth with comorbid epilepsy and psychiatric disorders: a case series. J Child Adolesc Psychopharmacol 2004; 14:295-310. [PMID: 15319026 DOI: 10.1089/1044546041649075] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]
Abstract
OBJECTIVE The aim of this study was to study risperidone use in pediatric patients with comorbid epilepsy and psychiatric disorders. METHOD We retrospectively reviewed the outpatient psychopharmacology medical records of patients with epilepsy, aged 19 and younger, who received risperidone for psychiatric disorders. RESULTS Twenty-one (21) youths (mean age, 12.0 +/- 4.2 years) met our criteria for review. Mean risperidone dosage was 2.4 +/- 3.5 mg/day. Target symptoms included severe aggression, severe agitation, psychosis, and self-injurious behavior. Diagnoses included attention-deficit hyperactivity disorder (ADHD), learning disorder, and impulse control disorder. Seizure type was partial complex in 12 patients, generalized in 6 patients, neonatal in 1 patient, myoclonic in 1 patient, and unclassified in 1 patient. The average number of previous psychotropic trials was 3.5 +/- 3.0. Using a definition of response of a Clinical Global Impressions (CGI) improvement score of 2 or less, 15 patients (71%) were considered responders. Adverse effects were none to slight in 16 patients, moderate in 4 patients, and severe in 1 patient. Seizures did not worsen in any patient. CONCLUSIONS Risperidone was associated with a clinically significant global improvement, without seizure exacerbation in youths with epilepsy and psychiatric disorders. Despite the limitations of the study design, the 71% responder rate is noteworthy in this treatment-refractory group.
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Koller EA, Cross JT, Doraiswamy PM, Malozowski SN. Pancreatitis associated with atypical antipsychotics: from the Food and Drug Administration's MedWatch surveillance system and published reports. Pharmacotherapy 2004; 23:1123-30. [PMID: 14524644 DOI: 10.1592/phco.23.10.1123.32759] [Citation(s) in RCA: 72] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
STUDY OBJECTIVE To investigate the relative numbers and clinical characteristics of pancreatitis in patients treated with the atypical antipsychotic agents, clozapine, olanzapine, and risperidone, versus the conventional neuroleptic, haloperidol. DESIGN Pharmacovigilance study of pooled, spontaneously reported adverse events. SETTING Government-affiliated drug evaluation center. PATIENTS One hundred ninety-two patients who developed pancreatitis during treatment with one or more antipsychotic agents. INTERVENTION Patients were identified with the Food and Drug Administration's MedWatch surveillance program and a MEDLINE search. MEASUREMENTS AND MAIN RESULTS Most cases of pancreatitis occurred within 6 months after the start of therapy with one or more antipsychotic agents. Of the reports of pancreatitis occurring in conjunction with these drugs, 40%, 33%, 16%, and 12% were in patients receiving treatment with clozapine, olanzapine, risperidone, and haloperidol, respectively. In 50% of the patients receiving haloperidol, an atypical antipsychotic was listed as a concomitant drug. Valproate was administered concomitantly in 23% of patients. Hyperglycemia and acidosis, although uncommon, developed with all the drugs except haloperidol. Twenty-two patients died. In contrast to patients who developed pancreatitis while receiving an atypical antipsychotic, those who developed the disease while receiving haloperidol were women and tended to be older. CONCLUSION The number of reports involving the three atypical antipsychotic agents and the relative paucity of reports involving haloperidol, despite its more extensive patient exposure, suggest that atypical antipsychotics may precipitate pancreatitis. However, the risk may not be the same with all agents; pancreatitis was reported most frequently with clozapine, followed by olanzapine, and then risperidone. The temporal relationship of the onset of pancreatitis with the start of drug therapy further supports a cause-and-effect relationship.
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Affiliation(s)
- Elizabeth A Koller
- Division of Metabolic and Endocrine Drug Products, Center for Drug Evaluation and Review, Food and Drug Administration, Rockville, Maryland, USA
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Current awareness in pharmacoepidemiology and drug safety. Pharmacoepidemiol Drug Saf 2002; 11:169-74. [PMID: 12004884 DOI: 10.1002/pds.658] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022]
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