Terfenadine is widely regarded as a non sedative antihistamine. In The Netherlands, it was the first antihistamine to obtain a waiver of package labelling warning of possible adverse effects on driving behaviour. The subjects were 8 male and 2 female patients whose adverse reactions to terfenadine had been previously documented by their physicians. The driving test comprised a 24 km within city test and a 100 km open highway test. Data collected in both tests were analysed using repeated applications of students t-test. The subjects' self reported alertness, sleep quality effort and driving quality were also recorded, analysed and compared between conditions. Finally, serum samples were obtained after each test sequence and assayed to confirm the presence of the drug when expected. The results of the study show no significant differences between driving performance or subjective measurement in placebo and terfenadine conditions. These results offer no reason for the dutch drug registration authorities to revise waiver of the package label warning for terfenadine.
Abstract