Cough and cold medicines should not be recommended for children

Abstract

Cough belongs to the most common symptoms of respiratory tract infections, and irritating cough is often the reason why the parents decide to come with their children to an emergency room or department. The majority of respiratory infections in children are mild viral infections treated at home without any medicines. Most symptomatic and supportive medicines belong to the overthecounter medicines. The available evidencebased guidelines recommend relieving of fever and pain if needed, with appropriate overthecounter drugs, but they do not recommend the use of cough and cold medicines. There is no researchbased evidence for the effectiveness of cough medicines, and they may have side effects, especially in under schoolaged children.1 The Finnish Current Care Guidelines on lower respiratory tract infections in children published in 2014 did not recommend use of cough or cold medicines.2 In the United States, the Food and Drug Administration recommended in 2008 that children younger than 2 years should not use cough and cold medicines because of concerns about their efficacy and safety. Thereafter, manufacturers relabelled cough and cold medicines only for children older than 4 years, and the American Academy of Pediatrics recommended avoiding cough and cold medicines in children younger than 6 years.3 Subsequent national USA utilisation studies showed decreased use of paediatric cough and cold medicines.4,5 This decreasing trend has continued through the 2010s and the overall doctoral recommendations have declined more strongly for children younger than 2 years, and the recommendations of opioidcontaining medicines for children younger than 6 years.3 However, the trend in prescriptions for antihistamines increased at the same time.3 The Finnish Statistics of Medicines contains, since 2007, annual national data on the sales of medicines in the pharmacies with comparable groupings and drug consumption indicators (available at www.kela.fi). In these reports, cough and cold medicines have been divided into four groups, which are mucolytics, cough depressants, expectorants and combinations. The separation of mucolytics and expectorants is artificial, and in addition, the effects of the drugs of both groups have been questioned in respiratory infections in children. The most useful indicators reflecting the consumption and costs of medicines are the defined daily doses (DDD)/1000 inhabitants/year and the total sales/year. In the national data, the figures contain both medicines prescribed by a doctor and overthecounter medicines bought without prescriptions. The register does not contain information, whether the overthecounter medicine was bought for children and whether for adults. In the case of cough medicines, the use by age cannot be judged even indirectly, since cough medicines are administered as mixtures or soluble tablets to allage consumers. In Finland, the overall use of cough and cold medicines decreased by 46.4% from 2007 to 2019 when estimated with the DDD/1000/ year figures and by 22.3% when estimated with figures of the total sales. The DDD/1000/year was 8.82 in 2007 and 4.73 in 2019. In 2007, the total sales of cough and cold medicines were € 13.7 million, and in 2019, they still were € 10.7 million. When the years 2007 and 2019 are compared, the consumption of mycolytics estimated with DDD/1000/year figures increased marginally, but the total sales increased by 38.5%. Two new medicines dornasealpha for pulmonary complications of cystic fibrosis and ambroxol for adults and over 12yearold children were licenced between 2007 and 2019. Instead, the consumption of cough suppressants, expectorants and combinations decreased by 64.8%, 82.0% and 63.6%, respectively. The DDD/1000/year figures were 3.07 versus 1.08 for cough suppressants, 0.5 versus 0.09 for expectorants and 2.8 versus 1.0 for combinations. In the cough suppressant group, the consumption of dextrometorphan decreased by 31.6% and that of other opium alkaloids by 69.1%. The total sales decreased accordingly, being in 2019 € 2.3 million for cough suppressant, € 0.2 million for expectorants and € 3.5 million for the combinations of cough suppressant and expectorants. The Finnish authors publish in this issue of Acta Paediatrica their results on the prescriptions of cough suppressants to children at five outpatient clinics.6 In all, 1661 paediatric outpatient records for lower respiratory tract infections were reviewed in two public health emergency rooms, in two private outpatient clinics and in the emergency department of a teaching hospital. The authors compared two eras, consisting of two infection seasons before and two after the publication of the Finnish Current Care Guidelines for children s lower respiratory infections in 2014. The guidelines advised not to prescribe or recommend cough or cold medicines for children.2 Cough suppressants were prescribed, on average, to 8.5% of children before the guidelines and to 9.7% after the guidelines.6 The figures varied between 5.6% and 13.1% in the public health emergency rooms, and between 11.6% and 24.0% in the private outpatient clinics. None of the children discharged from the emergency