North American Journal of Medical Sciences · 2012 · 11 citations · 16 references
MedicineCardiologyPharmacologyCardiovascular PharmacotherapyClinical PharmacologyPharmacovigilanceAdverse Drug Event PreventionAdverse Drug ReactionsAdverse EffectsCardiac MedicationsCardiovascular Drug SafetyCardiovascular PharmacologyAdverse Cardiovascular Drug EventsAdverse Drug Reaction AnalysisAdverse Drug Reaction EpidemiologyCross-sectional Incidence StudyPreventable Adverse Drug ReactionsSerious Adverse Drug Reactions
BACKGROUND: Adverse drug reactions (ADRs) occur frequently with cardiovascular drugs leading to change in therapy, increasing morbidity, and mortality. AIM: The study was conducted to evaluate the incidence of ADRs due to angiotensin-converting enzyme Inhibitors in cardiology department. MATERIALS AND METHODS: A cross-sectional observational study was carried out for a period of 6 months. The data were assessed for the pattern of the ADRs with respect to patient demographics, nature of the reaction, outcome of the reactions, causality, severity, and preventability. RESULTS: Among 692 patients, 51 (7.36%) had developed 60 ADRs, and majority of cases (56.66%) were in the age group of >61 years and most of them were developed in female (80%). The common ADRs observed were cough, hypotension, hyperkalemia, and acute renal failure. In 21.66% cases the dose of the suspected drug was altered and in 78.33% cases the drug was withdrawn. Considering the outcome, 93.33% of cases recovered from ADRs, whereas in 6.66% cases were continuing. Causality assessment showed that majority of ADRs was probable and were found to be moderately severe. CONCLUSION: Our study concludes geriatrics and female patients have higher incidence of ADRs. So early identification and management of ADRs are essential for this population.
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A method for estimating the probability of adverse drug reactions
C. A. Naranjo, U. Busto, Edward M. Sellers et al. · Clinical Pharmacology & Therapeutics · 1981 · 11.6K citations
Predisposing Factors in Adverse Reactions to Drugs
N. Hurwitz · BMJ · 1969 · 441 citations · Full text
Medicine, Pharmacology, Allergy +9