EFFECT OF TERFENADINE ON DRIVING ABILITY OF SELECTED PATIENTS

HET EFFECT VN TERFENADIE OP DE RIJVAARDIGHEID VAN GESELECTEERDE PATIENTEN

Terfenadine is widely regarded as a non sedative antihistamine. In the Netherlands, it was the first antihistamine to obtain a waiver of package labeling 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 analyzed using repeated applications of students t-test. The subjects' self reported alertness, sleep quality effort and driving quality were also recorded, analyzed 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. (TRRL)

• Availability:
  • Find a library where document is available. Order URL: http://worldcat.org/isbn/9051470010
• Corporate Authors:

  Rijksuniversiteit Limburg

  Instituut voor Veiligheid en Gedrag, P.O. Box 616
  Maastricht,   Netherlands 
• Authors:
  • Schoenmakers, EAJM
  • Riedel, W J
  • Gier, J J
  • Dijke, CPH van
  • Beuman, G H
  • O'Hanlon, J F
• Publication Date: 1987-5

Language

• Dutch

Media Info

• Features: References;
• Pagination: 39 p.

Subject/Index Terms

• TRT Terms: Alertness; Antihistamines; Behavior; Diseases and medical conditions; Driver performance; Drivers; Human subject testing; Labeling; Personnel performance; Physiological fatigue; Warning systems
• Geographic Terms: Netherlands
• ITRD Terms: 9001: Behaviour; 1855: Driving (veh); 2226: Driving aptitude; 2242: Drugs; 2222: Fatigue (human); 2154: Medical aspects; 8078: Netherlands; 6288: Test method; 9113: Warning
• Subject Areas: Highways; Safety and Human Factors;

Filing Info

• Accession Number: 00475801
• Record Type: Publication
• Source Agency: Institute for Road Safety Research, SWOV
• ISBN: 90-5147-001-0
• Files: ITRD, TRIS
• Created Date: Aug 31 1988 12:00AM