Vol 17, Issue 4, 2024 Online - 2455-3891 Print - 0974-2441 ADVERSE DRUG REACTIONS OF BACLOFEN, NALTREXONE, AND ACAMPROSATE IN PATIENTS HAVING ALCOHOL DEPENDENCE: A CROSS-SECTIONAL PHARMACOVIGILANCE STUDY SUDHIR PANDURANG PANDHARE 1 , DEVESH GOSAVI 1 , KSHIROD KUMAR MISHRA 2 , HARSHAL SHRIRAM SATHE 2 * 1 Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra, India. 2 Department of Psychiatry, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra, India. *Corresponding author: Harshal Shriram Sathe; Email: harshals@mgims.ac.in Received: 03 November 2023, Revised and Accepted: 25 December 2023 ABSTRACT Objectives: The research aims to investigate the prevalence and patterns of adverse drug reactions (ADRs), gauge the severity of these reactions, establish causality in ADR cases, and assess the preventability of such adverse reactions. Methods: ADR information was gathered through personal interviews with patients or their relatives. Causality was assessed using the Naranjo algorithm, and a modified Hartwig and Siegel Severity Assessment Scale was used for estimating the severity of ADR. ADRs were grouped into various preventability categories based on the modified Schumock and Thornton criteria. Results: The total number of patients evaluated in the baclofen, naltrexone, and acamprosate groups was 65, 28, and 42, respectively. The most commonly reported adverse events with baclofen were nausea (31.25%), followed by fatigue (18.75%) and headache (12.50%). The majority of patients receiving acamprosate reported nausea (57.14%), followed by diarrhea (28.57%). Patients receiving naltrexone most commonly reported nausea (35.71%), followed by abdominal pain (21.43%) and headache (14.28%). Conclusion: This study shed light on the prevalence, severity, causality, and preventability of ADRs associated with anti-craving agents used to treat patients with alcohol withdrawal syndrome, providing valuable insights into the safety profiles of these medications. Keywords: Pharmacovigilance, Anticraving drugs, Adverse drug reactions, Safety profile. INTRODUCTION Alcohol consumption ranks as the world’s third-largest risk factor for disease and disability, with far-reaching socio-economic consequences such as child neglect, abuse, workplace absenteeism, and violence [1]. In response, researchers have endeavored to counteract the pleasurable effects of alcohol by developing anticraving medications that act on specific neurotransmitters [2]. The FDA-approved medications for treating alcohol use disorders include disulfiram, acamprosate, and naltrexone [3]. The Pharmacovigilance Program of India was launched by the Government of India on July 14, 2010, with the All India Institute of Medical Sciences in New Delhi as the National Coordination Centre, focusing on monitoring adverse drug reactions (ADRs) to safeguard public health [4]. The World Health Organization defines ADRs as harmful and unintended responses to drugs, occurring at normal therapeutic doses [5]. ADRs stand among the leading causes of morbidity and mortality, leading to hospitalizations and treatment non-compliance, often initiating medication discontinuation [5,6]. Despite the importance of ADR monitoring, health-care professionals lack awareness due to several reasons, such as the perceived commonality of ADRs, uncertainty regarding causality, limited knowledge of reporting procedures, a general lack of awareness, and the fear of legal ramification [7,8]. Baclofen, a centrally acting muscle relaxant belonging to the GABA mimetic drug group, selectively targets GABA receptors [9]. It shows promise as an anti-craving agent for alcoholism, but common side effects include significant fatigue, sleepiness, insomnia, dizziness, paresthesia, nausea, vomiting, and less frequently, sensory changes and sexual alterations, including changes in libido, as well as various forms of pain, including headaches [9]. Naltrexone, an opioid antagonist, is thought to reduce the desire to drink by blocking the pleasurable “high” effects of alcohol [9]. Early treatment may lead to gastrointestinal adverse events (AEs), including nausea, vomiting, and abdominal discomfort, as well as headaches and fatigue. In addition, hepatotoxicity has been reported, primarily in obese patients receiving high daily doses (100–300 mg), which can lead to immediate and severe withdrawal in opiate-dependent patients [10,11]. Acamprosate, functioning as an N-Methyl D-aspartate receptor antagonist with modest GABA receptor agonistic activity, is now the most widely prescribed therapeutic agent for alcoholism in the United States. It is generally well-tolerated, with no reported deaths or drug-related AEs. Diarrhea is the most common reason for discontinuation [9,12]. Given the increasing use of anti-craving agents, it is imperative to assess their safety profile. However, there are only a limited number of controlled clinical trials available on these drugs, indicating the need for larger studies in diverse treatment settings. Data on the safety of anti-craving agents in India, particularly in the central region, is scarce. Therefore, our study objectives center around the monitoring of ADRs associated with anti-craving agents prescribed within the Department of Psychiatry at a tertiary care teaching hospital in central India. The research aims to investigate the prevalence and patterns of ADRs, gauge the severity of these reactions, establish causality in ADR cases, and assess the preventability of such adverse reactions. METHODS Study settings and study population The present research employed a cross-sectional and observational design. It was conducted at the psychiatry outpatient department © 2024 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/ licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ajpcr.2024v17i4.49791. Journal homepage: https://innovareacademics.in/journals/index.php/ajpcr Research Article