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

ABSTRACT

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Cough and cold medicines are frequently used in children to treat upper respiratory tract infections without solid proof of benefits. • Safety issues have been raised about the use of these drugs in young children. • In 2007 international warnings were issued advising against use of these drugs in young children. WHAT THIS STUDY ADDS • Cough and cold medicines prescribing by primary care physicians has not really been influenced by international warnings in the Netherlands, where no additional national warnings were made and only partially in Italy. • A concerted action should be taken in Europe to advise strongly against the OTC use and prescription of cough and cold medicines in young children. 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.