Prescribed fenoterol and death from asthma in New Zealand, 1981-83: case-control study.

A case-control study was conducted to examine the hypothesis that fenoterol by metered dose inhaler (MDI) increases the risk of death in patients with asthma. The case group comprised 117 patients aged 5-45 who died of asthma between August, 1981, and July, 1983. For each case, 4 controls, matched for age and ethnic group, were selected from asthma admissions to hospitals to which the cases themselves would have been admitted, had they survived. The relative risk of asthma death in patients prescribed fenoterol by MDI was 1.55 (95% CI 1.04-2.33, p = 0.03). The possibility of confounding or effect modification by severity was assessed by consideration of subgroups defined by markers of asthma severity. The fenoterol MDI relative risk was 2.21 (95% CI 1.26-3.88, p = 0.01) in patients prescribed three or more categories of asthma drugs, 2.16 (95% CI 1.14-4.11, p = 0.02) in patients with a hospital admission for asthma during the previous 12 months, and 6.45 (95% CI 2.72-15.3, p less than 0.01) in patients prescribed oral corticosteroids at time of death or admission. In the group of patients with the most severe asthma (defined by a hospital admission during the previous year and prescription of oral corticosteroids) the fenoterol MDI relative risk was 13.29 (95% CI 3.45-51.2, p less than 0.01). After adjustment for severity, no other asthma treatment commonly used in New Zealand seemed to be associated with an increased risk of asthma death. Not all sources of bias can be definitely excluded; however, when considered together with other epidemiological and experimental evidence, these findings are consistent with the hypothesis that use of fenoterol by MDI increases the risk of death in severe asthma.