Background: Serious Adverse Drug Reactions (sADRs) are one of the important causes of morbidity and mortality. In India, pharmacovigilance practices are evolving but comprehensive regional data on sADRs is lacking. Understanding how sADR prevalence in India compares with global patterns is essential to improve patient safety. Aims and Objectives: This study aimed to compare the prevalence of selected sADRs associated with commonly used drugs in India and other countries, and to examine the contributing factors. Materials and Methods: A list of drugs was compiled using a generic drug index. A PubMed search was conducted to estimate the prevalence of sADRs in the Indian patient population. Additional data were obtained from Indian Pharmacopoeia Commission publications and FAERS (FDA Adverse Event Reporting System) database. Data was extracted and tabulated for comparison. Results: Twenty-two studies (including FAERS data) met the inclusion criteria, and ten drugs with their sADRs were selected for comparison. Indian patients exhibited a higher prevalence of several sADRs- for example, Linezolid-induced neuropathy (93.3% in India vs. 1.6% globally) and Non Steroidal Anti-Inflammatory Drugs (NSAID)-induced nephrotoxicity (27.88% vs. 13%). Lamivudine-induced hearing loss and Pioglitazone-induced bladder cancer showed significantly lower rates of sADRs in Indian studies. Conclusion: Marked differences in the prevalence of sADRs between India and other countries highlight the need for sensitising physicians to these differences and associated implications in prescribing and patient management.
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Keywords
Adverse Drug Reaction
Adverse Effect
India
Pharmacovigilance
Prevalence
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