Objective: To evaluate the long-term safety of fexofenadine compared with placebo.
Design: Two placebo-controlled, double-blind, randomised, parallel-group studies.
Setting: Twenty-nine investigational centres in the USA.
Patients: Healthy volunteers aged 12 to 65 years.
Interventions: In a 6-month study, 436 volunteers received either fexofenadine 60mg twice daily or placebo; in a 12-month study, 477 volunteers received fexofenadine 240mg once daily or placebo.
Main Outcome Measures and Results: In both studies, adverse events, 12-lead ECGs, laboratory evaluations and vital signs were recorded. There was no statistically significant difference in the incidence of adverse events when fexofenadine was compared with placebo. The most frequently reported treatment-related adverse event was headache, which occurred with a similar incidence for fexofenadine compared with placebo in both studies. Fexofenadine was not associated with statistically significant changes in 12-lead ECGs or clinically relevant changes in laboratory evaluations or vital signs when compared with placebo.
Conclusions: These two long-term studies demonstrate that fexofenadine, at doses up to 240mg once daily for up to 12 months in healthy volunteers, is safe and well tolerated.
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Nathan, R.A., Mason, J., Bernstein, D.I. et al. Long-Term Tolerability of Fexofenadine in Healthy Volunteers. Clin. Drug Investig. 18, 317–328 (1999). https://doi.org/10.2165/00044011-199918040-00008
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