[Data on the safety of antihistaminics obtained from published clinical trials].
BACKGROUND
We studied H1 antihistaminic safety, with respect to CNS, and clinical trial validity to determine its adverse effects and generalize the results.


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.
Departamento de Biología Celular y Farmacología, Facultad de Medicina de Valladolid. angelrop@hotmail.com
A
A
Rodríguez Paredes
J L
JL
González
D000367:Age Factors; D002986:Clinical Trials as Topic; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects; D017336:Loratadine / Q000009:adverse effects; D011725:Pyridines / Q000009:adverse effects; D018401:Sample Size; D017678:Sex Distribution
D006634:Histamine H1 Antagonists; D007093:Imidazoles; D011725:Pyridines; D017336:Loratadine; C069596:noberastine