Publication:

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.