| アブストラクト | Background and objectives Pregabalin, an antiepileptic drug with anxiolytic and analgesic properties, has been increasingly misused for recreational purposes. This article aimed to assess the extent and patterns of pregabalin misuse in India from a global perspective using pharmacovigilance data. Methods A retrospective post-market observational study was conducted using VigiBase reports on pregabalin-related adverse drug reactions between January 2011 to April 2024. Data extraction and analysis were performed between April to May 2024. Relevant reports were identified using MedDRA term and analysed at global and Indian levels. Results Among 40,582,030 adverse drug reactions (ADRs) in VigiBase, 163,476 involved pregabalins globally. Of these, 8,058 pregabalin abuse-related reports were identified, mainly intentional product misuse (n=3,560; 44.17%), intentional product use issue (n=2,203; 27.34%), and drug abuse (n=1,701; 21.11%). Globally, the USA reported the higher number of pregabalins ADRs, (n=96,867; 59.2%), followed by the Republic of Korea 9.4%, Japan 3.8% and France 3.6%. In India, 50 pregabalin-abuse reports were identified; of which drug abuse (n=26, 52%), intentional overdose (n=13, 26%), intentional product misuse (n=13, 26%), intentional product use-issue (n=4, 8%) and substance use disorder (n=1, 2%) were reported in patients within 18-44 yr (n=36, 72%) and predominantly in males (n=45, 90%). About 94% of reports were deemed serious, with 54% (n=27) requiring prolonged hospitalisation. Interpretation and conclusions Pregabalin misuse in India is prevalent, especially among adult men, and is often associated with serious outcomes. These findings emphasise the urgent need for stricter regulation and targeted interventions to limit misuse and reduce associated risks. |
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| 組織名 | Department of Pharmacovigilance Programme of India, #Indian Pharmacopoeia;Commission, Ministry of Health & Family Welfare, Government of India, Ghaziabad,;Uttar Pradesh, India.;Department of Materiovigilance Programme of India, #Indian Pharmacopoeia |
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