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[Data on the safety of antihistaminics obtained from published clinical trials]
A Rodríguez Paredes1, J L González
1Departamento de Biología Celular y Farmacología, Facultad de Medicina de Valladolid. angelrop@hotmail.com
Background:
We studied H1 antihistaminic safety, with respect to CNS, and clinical trial validity to determine its adverse effects and generalize the results.
Methods And Results:
We employed clinical trials published between 1990-94, selecting them according to several quality criterion to obtain reliable and extrapolable conclusions. Patients that use modern antihistaminics have less adverse effects (32.5%), than those patients that use classics ones (78.6%) and similar to placebo (27.7%). Loratadine (28.4%) and noberastine (22.3%) are the antihistaminics with less adverse effects. Sedation (13.2%) and fatigue (4.9%) are the adverse effects more frequently produced by antihistaminics. Headache (6.7%) that is a frequent adverse effect, has a doubtful causality relationship with the use of antihistaminic.
Conclusions:
Second generation antihistaminics have less adverse effects and similar efficacy than classics ones. Noberastine and loratadine are the antihistaminics with less adverse effects in this study.