Antimicrobials associated adverse drug reaction profiling: a four years retrospective study (Pharmacovigilance study)

Abstract

Background: All drugs profoundly modify our biological processes and may manifest as adverse drug reactions (ADRs), which are unpredictable and inevitable consequences. Antibiotics are a common cause of ADR, necessitating stopping or change of antibiotics. The incidence of ADRs increases with the number of drugs prescribed in a prescription, and antibiotics are rarely prescribed as monotherapy. Aim: The study aimed to assess frequency, class of antibiotics, symptoms, causality, the severity of antimicrobial-associated ADRs, and see the demographic distribution. Methods: ADRs were collected and filled in suspected ADR forms and sent via vigiflow to the National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI). These ADR reports, termed individual case safety reports (ICSRs), were analyzed from Jan 2016 to Dec 2019. Results: A total of 414 (54.33%) ICSRs of 762 were identified as antimicrobial-associated. Adults in the age group 19-65 years accounted for 345 (83.09%) of ADRs. A total of 192 (46.38%) were males, and 222 (53.14%) were females. Skin and subcutaneous tissue System organ class was involved in 54% of cases. In the causality assessment, 268 (64.49%) were "probable," 123 (29.71%) were "possible," and 23 (5.56%) were "certain." On severity assessment, 256 ADRs (61.83%) were mild, 133 (32.12%) were moderate, and 25 (6.03%) were severe. A total of 54 antimicrobial agents, excluding anti-tubercular drugs, were identified, and antibacterial accounted for 268 (64.73%) ADRs, followed by antiviral 90 (21.73%), antiprotozoal agents 33 (7.97%) antimalarials anti-scabicidal, antifungal accounting for the remaining. Conclusion: Antimicrobials play a crucial role in treating infections, and utmost vigilance during antimicrobials prescription reduces the frequency and severity of the ADRs, thereby reducing the morbidity and mortality and the pharmacoeconomic burden to the health care system. Pharmacovigilance must be boosted to ensure the safe and effective use of antibiotics and reduce the occurrence of ADRs.

Nephrotoxıcıty in Patıents on Tenofovır vs Non-Tenofovır Contaınıng Art Regımen: An Observatıonal Study

“…Previous studies have found association of various Adverse Drug Reactions (ADRs) affecting all body system with both TLE and non-TLE based regimen but the frequency and severity were higher with ZLN regimen [7] which is similar to our findings. In a study conducted in 2020 also shows that anti-retroviral agents account for 21.73% ADRs, and TLE alone accounts for 16.42% ADRs [35]. Anemia was the most common ADR in TLE arm which could be attributed to bone marrow suppression due to Tenofovir.…”

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“…Jung IY et al 2017 reported that fluoroquinolones were the second most frequent cause of ADRs among antimicrobials, accounting for 16% of cases 19 . Two studies found that third-generation cephalosporins were more responsible compared to other generations cephalosporins 29,30 . In the present study, ceftriaxone was the only cephalosporin responsible for the occurrence of ADRs.…”