Effects of safety warnings on prescription rates of cough and cold medicines in children below 2 years of age

AIM The aim of the study was to assess the influence of national and international warnings on the prescription rates of cough and cold medicines (CCMs) in the youngest children (< 2 years) in the Netherlands and Italy. METHODS Analysis of outpatient electronic medical records of children < 2 years in Italy and the Netherlands was carried out. Age and country specific prescription prevalence rates were calculated for the period 2005-08. Comparisons of prescription rates in 2005 (pre) and 2008 (post) warnings were done by means of a chi-square test. RESULTS The cohort consisted of 99 176 children < 2 years of age. After international warnings, overall prescription rates for CCMs decreased slightly from 83 to 77/1000 person years (P = 0.05) in Italy and increased in the Netherlands from 74 to 92/1000 children per year. Despite the international warnings, prescription rates for nasal sympathomimetics and opium alkaloids increased in the Netherlands (P < 0.01). In Italy a significant decrease in the prescription rates of opium alkaloids and other cough suppressants (P < 0.01) was observed, and also a significant reduction in use of combinations of nasal sympathomimetics. CONCLUSION Despite the international safety warnings and negative benefit-risk profiles, prescription rates of cough and cold medicines remain substantial and were hardly affected by the warnings, especially in the Netherlands where no warning was issued. The hazards of use of these medicines in young children should be explicitly stipulated by the European Medicines Agency and all national agencies, in order to increase awareness amongst physicians and caretakers and reduce heterogeneity across the EU.