There is no rationale for sedating antihistamines as prescription-free drugs for self-medication

Potential dangers of the indiscriminate use of first-generation H1-antihistamines.

A GA²LEN (Global Allergy and Asthma European Network) task force reviewed the literature (via Medline and Embase) and performed a media audit of coverage in the United States from 1996 to 2008 of accidents and fatal adverse events in which H1-antihistamines were implicated. The goal of the effort was to enhance consumer protection by bringing to the attention of regulatory authorities, physicians and the general public the potential dangers of the indiscriminate use of first-generation H1-antihistamines purchased over-the counter in the absence of appropriate medical supervision. They found that first-generation H1-antihistamines, all of which are sedating, are generally regarded as safe by laypersons and healthcare professionals because of their long-standing use. However, they reduce rapid eye movement (REM)-sleep, impair learning and reduce work efficiency. They have been implicated in civil aviation, motor vehicle and boating accidents. They have also been responsible for deaths as a result of accidental or intentional overdosing. In conclusion this review raises the issue of better consumer protection by recommending that older first-generation H1-antihistamines should no longer be available over-the-counter as prescription- free drugs for self-medication of allergic and other diseases now that newer second-generation non-sedating H1-antihistamines with superior risk/benefit ratios are widely available at competitive prices.

Church MK, Maurer M, Simons FER et al. Risk of first-generation H1-antihistamines: a GA²LEN position paper. Allergy 2010; 65(4):459-466.