REPORTING AND MONITORING OF ADVERSE DRUG REACTIONS WITH CARDIAC DRUGS

Abstract

Adverse drug reactions are a common medical problem, especially in patients who need multiple therapies. Patients with cardiovascular diseases are mostly on polypharmacy, so adverse effects of drug are quite common. The objective of the present study was to determine the severity and causality of adverse drug reactions in patients with cardiovascular drugs. This prospective and observational study enrolled patients who were on cardiac drugs and experienced adverse drug reaction. Naranjo ADR probability scale was used to establish the causality. A total of 231 ADRs were reported from 148 patients. Of these 148 patients, 39 patients were hospitalized primarily due to the development of ADRs, while 109 patients developed ADRs during hospital stay. Headache was the most frequent detected ADR (24.2%). The systems most commonly affected were the central nervous (33.3%) and gastrointestinal (16.5%). About 23.4% of the reactions were associated with calcium channel blockers followed by nitrates and ACE inhibitors. Assessing the severity and preventability of ADRs revealed that 1% of ADRs were detected as severe and 39% as preventable reactions.

The main treatment of reaction was the withdrawal of the suspected drug(s). Occurrence of adverse drug reactions was common in Indian population and majority of them often were predictable and preventable. Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.