Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.
The objective of this study is to evaluate the effects of bupropion as an add-on therapy to selective serotonin reuptake inhibitor (SSRI) on patients of major depressive disorder with partial response. This prospective, randomized, controlled and single-blind study was conducted in sixty patients suffering from major depressive disorder as per Diagnostic and Statistical Manual (DSM)-IV TR criteria, who were having Hamilton depression rating scale (HDRS) score ≥16 after 4 weeks of treatment with SSRIs. Group A received SSRI plus placebo and group B received SSRI plus bupropion. Evaluation was performed based on changes in HDRS score, Montgomery and Asberg depression rating scale (MADRS), Amritsar depressive inventory (ADI) and spontaneously reported adverse effects. There was a significant decrease in the HDRS, MADRS and ADI scores as compared to baseline in both groups. However, the mean decrease in depression score was more in group B than in group A. The percentage decrease of remitters was also significantly more in group B (60% as per HDRS score and 63% as per MADRS score), as compared to group A (24% as per HDRS score and 27% as per MADRS score) (p < 0.05), at the end of treatment. In conclusion, bupropion add-on can act as augmenting agent in patients of depression with partial response to SSRIs.
Among the immune-mediated reactions, anaphylaxis is the most severe form. As a postoperative analgesia, diclofenac sodium, and nonsteroidal anti-inflammatory drug is commonly used. Intravenous (IV) diclofenac sodium-induced anaphylaxis is very rare. We are presenting a case of IV diclofenac-induced anaphylactic reaction, occurred during the surgery in a female patient of 21 years of age. The sign and symptoms of the reaction resembled an anaphylactic reaction. Temporal relationship with IV diclofenac administration and development of the clinical features of the reaction found to be probable. The health-care professionals should be aware of such rare and serious reactions so that it can be diagnosed and treated early. The clinical importance associated with the case encouraged us to report this rare complication of IV diclofenac.
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