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.
Monahan BP, Ferguson CL, Killeavy ES, et al. Torsades de pointes occurring in association with terfenadine use. J Am Med Assoc 1990; 264(21): 2788–90CrossRefGoogle Scholar
Woosley RL. Cardiac actions of antihistamines. Ann Rev Pharmacol Toxicol 1996; 36: 233–52CrossRefGoogle Scholar
Paul E, Berth-Jones J, Ortonne J-P, et al. Fexofenadine hydrochloride in the treatment of chronic idiopathic urticaria: a placebo-controlled, parallel-group, dose-ranging study. J Derm Treat 1998; 9: 143–9CrossRefGoogle Scholar
Simons FER, Simons KJ. Peripheral H1-blockade effect of fexofenadine. Ann Allergy Asthma Immunol 1997; 79: 530–2PubMedCrossRefGoogle Scholar
Bronsky EA, Falliers CJ, Kaiser HB, et al. Effectiveness and safety of fexofenadine, a new nonsedating H1-receptor antagonist, in the treatment of fall allergies. Allergy Asthma Proc 1998; 19: 135–41PubMedCrossRefGoogle Scholar
Bernstein DI, Schoenwetter WF, Nathan RA, et al. Efficacy and safety of fexofenadine hydrochloride for treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol 1997; 79: 443–8PubMedCrossRefGoogle Scholar
Day JH, Briscoe MP, Welsh A, et al. Onset of action, efficacy and safety of a single dose of fexofenadine hydrochloride for ragweed allergy using an environmental exposure unit. Ann Allergy Asthma Immunol 1997; 79: 533–40PubMedCrossRefGoogle Scholar
Russell T, Stoltz M, Weir S. Pharmacokinetics, pharmacodynamics, and tolerance of single- and multiple-dose fexofenadine hydrochloride in healthy male volunteers. Clin Pharmacol Ther 1998; 64(6): 612–21PubMedCrossRefGoogle Scholar
Vermeeren A, O’Hanlon JF. Fexofenadine’s effects, alone and with alcohol on actual driving and psychomotor performance. J Allergy Clin Immunol 1998; 101: 306–11PubMedCrossRefGoogle Scholar
Pratt C, Mason J, Russell T, et al. Effect of fexofenadine HCl on corrected QT interval (QTc). Allergy 1997; 52Suppl. 37:67Google Scholar
Woosley RL, Chen Y, Freiman JP, et al. Mechanism of the cardiotoxic actions of terfenadine. JAMA 1993; 269: 1532–6PubMedCrossRefGoogle Scholar
Lippert C, Ling J, Brown P, et al. Mass balance and pharmacokinetics of fexofenadine HCl in healthy, male volunteers [abstract S390]. Pharm Res 1995; 12 Suppl. 9Google Scholar
Robbins DK, Castles MA, Pack DJ, et al. Dose proportionality and comparison of single and multiple dose pharmacokinetics of fexofenadine (MDL 16455) and its enantiomers in healthy male volunteers. Biopharm Drug Dispos 1998; 19: 455–63PubMedCrossRefGoogle Scholar