Risk of first-generation H(1)-antihistamines: a GA(2)LEN position paper.
BACKGROUND
First-generation H(1)-antihistamines obtained without prescription are the most frequent form of self-medication for allergic diseases, coughs and colds and insomnia even though they have potentially dangerous unwanted effects which are not recognized by the general public.


OBJECTIVE
To increase consumer protection by bringing to the attention of regulatory authorities, physicians and the general public the potential dangers of the indiscriminate use first-generation H(1)-antihistamines purchased over-the counter in the absence of appropriate medical supervision.


METHODS
A GA(2)LEN (Global Allergy and Asthma European Network) task force assessed the unwanted side-effects and potential dangers of first-generation H1-antihistamines by reviewing the literature (Medline and Embase) and performing a media audit of US coverage from 1996 to 2008 of accidents and fatal adverse events in which these drugs were implicated.


RESULTS
First-generation H(1)-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 are implicated in civil aviation, motor vehicle and boating accidents, deaths as a result of accidental or intentional overdosing in infants and young children and suicide in teenagers and adults. Some exhibit cardiotoxicity in overdose.


CONCLUSIONS
This review raises the issue of better consumer protection by recommending that older first-generation H(1)-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 nonsedating H(1)-antihistamines with superior risk/benefit ratios are widely available at competitive prices.
Department of Dermatology and Allergy, Charité- Universitätsmedizin Berlin, Germany.
M K
MK
Church
M
M
Maurer
F E R
FE
Simons
C
C
Bindslev-Jensen
P
P
van Cauwenberge
J
J
Bousquet
S T
ST
Holgate
T
T
Zuberbier
D001921:Brain / Q000187:drug effects; D003071:Cognition / Q000187:drug effects; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy; D004366:Nonprescription Drugs / Q000009:adverse effects*; D014481:United States
D006634:Histamine H1 Antagonists; D004366:Nonprescription Drugs