Data on the safety of antihistaminics obtained from published clinical trials
Rodríguez Paredes, A.; González, J.L.
Allergologia et Immunopathologia 28(5): 272-277
2000
ISSN/ISBN: 0301-0546 PMID: 11270088 Document Number: 512844
We studied H1 antihistaminic safety, with respect to CNS, and clinical trial validity to determine its adverse effects and generalize the 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. 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.