Adverse drug reaction monitoring in Kuwait (1981-1984)

The methodologic, operational, and medical aspects of general population spontaneous adverse drug reaction (ADR) monitoring system organized in the State of Kuwait between June 1981 to June 1984 are described. The objectives of the study were to outline the procedures required for the establishment of a national ADR center in addition to studying the pattern of ADRs. Ethnic and sociocultural variables were factors influencing the frequency of adverse effects. A computer data base was created to handle incoming reports. A total of 704 reports were received from 26 hospitals and health clinics; the majority (90.5%) were classified as having a possible positive causal relationship. Anti-infectives were the most commonly reported drugs (32.2%), and cutaneous reactions were encountered most often (48.6%). Serious drug-induced reactions have been identified. Intake of nifedipine adversely affected glucose tolerance among diabetic and nondiabetic subjects. Bromocriptine causal sexual dysfunction was reported among women. Cimetidine and ethambutol were associated with optic neuritis and blindness. Metoclopramide and prochlorperazine resulted in dystonic reactions in children. Based on this study, the health authorities in Kuwait indicated their intention to establish a national ADR center.