Pharmacovigilance study of beta adrenergic receptor antagonists in patients visiting department of medicine of a tertiary care hospital, Surendranagar, Gujarat, India

Background: The objective of this study was to evaluate incidence, patterns, and severity of Beta blockers induced adverse drug reactions (ADR).Methods: A total of 500 patients taking Beta blockers were enrolled in the study by taking an informed consent. Reporting of all Beta blockers-induced ADRs was done by filling CDSCO ADR form. All ADR reports were evaluated according to WHO-UMC causality assessment scale.Results: A total of 64 ADRs (48 males and 18 females) was observed in 500 patients taking beta blockers. Of 64 ADRs, 20 (31.25%) were mild, 34 (53.13%) were moderate, and 10 (15.62%) were classified as severe. 26 (40.62%) ADRs were classified as Probable, followed by 22 (34.38%) ADRs were in Possible category, 8 (12.5%) were in certain category, 4 (6.25%) ADRs were unlikely and 4(6.25%) ADRs were Conditional. Among 64 ADRs, 22 (3.43%) patients developed bronchospasm, 10 (1.56%) bradycardia, 8 (1.25%) fatigue, 8 (1.25%) nausea/GI upset, 4 (0.62%) erectile dysfunction, 4 (0.62%) dry cough, altered lipid profile, insomnia, night mares and diarrhea are other rare ADRs.Conclusions: Incidence of ADRs by beta blockers is 12.80% with bronchospasm as the most common ADR followed by bradycardia. As atenolol is most frequently used beta blocker, ADRs due to atenolol are more common

Pharmacovigilance study of angiotensin-converting enzyme inhibitors in patients visiting Department of Medicine of a Tertiary Care Hospital, Surendranagar, Gujarat

Background: The objective of this study was to evaluate incidence, patterns, and severity of angiotensin-converting enzyme inhibitor (ACEI) induced adverse drug reactions (ADR).Methods: A total of 500 hypertensive patients taking ACEI was enrolled in the study by taking an informed consent. Reporting of all ACEI-induced ADRs was done by filling CDSCO ADR form. All ADR reports were evaluated according to WHO-UMC causality assessment scale.Results: A total of 53 ADRs (31 males and 22 females) was observed in 500 hypertensive patients taking ACEI. Of 53 ADRs, 22 (41.51%) were mild, 28 (52.83%) were moderate, and only 3 (5.66%) were classified as severe. 7 ADRs (13.21%) were classified as certain, 30 ADRs (56.60%) were in probable category, 8 (15.09%) were in possible category, 4 (7.55%) in unlikely category, 3 (5.66%) in conditional category (unclassified), and 1 ADR was in unassessable (unclassifiable) category. Among 53 ADRs, 24 (4.80%) patients developed dry cough, 8 (1.60%) hypotension, 2 (0.40%) headache, 2 (0.40%) dizziness, 3 (0.60%) nausea/bowel upset, 3 (0.60%) rashes, 2 (0.40%) developed angioedema, 3 (0.60%) dysgeusia, hyperkalemia, acute renal failure, proteinuria are rare.Conclusions: Incidence of ADRs by ACEIs is 10.60% with cough as the most common ADR followed by hypotension. As enalapril is most frequently used ACEI, ADRs due to enalapril are more common

Pharmacovigilance study of beta adrenergic receptor antagonists in patients visiting department of medicine of a tertiary care hospital, Surendranagar, Gujarat, India

Background: The objective of this study was to evaluate incidence, patterns, and severity of Beta blockers induced adverse drug reactions (ADR).Methods: A total of 500 patients taking Beta blockers were enrolled in the study by taking an informed consent. Reporting of all Beta blockers-induced ADRs was done by filling CDSCO ADR form. All ADR reports were evaluated according to WHO-UMC causality assessment scale.Results: A total of 64 ADRs (48 males and 18 females) was observed in 500 patients taking beta blockers. Of 64 ADRs, 20 (31.25%) were mild, 34 (53.13%) were moderate, and 10 (15.62%) were classified as severe. 26 (40.62%) ADRs were classified as Probable, followed by 22 (34.38%) ADRs were in Possible category, 8 (12.5%) were in certain category, 4 (6.25%) ADRs were unlikely and 4(6.25%) ADRs were Conditional. Among 64 ADRs, 22 (3.43%) patients developed bronchospasm, 10 (1.56%) bradycardia, 8 (1.25%) fatigue, 8 (1.25%) nausea/GI upset, 4 (0.62%) erectile dysfunction, 4 (0.62%) dry cough, altered lipid profile, insomnia, night mares and diarrhea are other rare ADRs.Conclusions: Incidence of ADRs by beta blockers is 12.80% with bronchospasm as the most common ADR followed by bradycardia. As atenolol is most frequently used beta blocker, ADRs due to atenolol are more common