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Adverse drug reactions to second-generation antihistamines in children

Whilst it is known first-generation antihistamines can cause somnolescence in a large proportion of patients, it was generally thought that second-generation antihistamines had fewer side effects. 1

Many children are prescribed systemic antihistamines, which are used for the treatment of allergic rhinitis, chronic spontaneous urticaria, atopic eczema, and allergic conjunctivitis. 1

Authors De Vries and van Hunsel studied the safety profile of second-generation anti histamines in order to inform prescribing physicians of relevant adverse drug reactions (ADRs). 1

The authors retrospectively studied reports of ADRs in children (0–18 years) taking systemic antihistamines made to the Netherlands Pharmacovigilance Centre Lareb between 1991 and 2014. 1

Over the 24-year study period, there were 228 relevant reports of ADRs to the Netherlands Pharmacovigilance Centre Lareb, of which five were considered serious. 1

The serious ADRs were three cases of convulsions, one of cardiac arrhythmia and one case of malignant neuroleptic syndrome, which resulted in death. 1The other ADRs were classified as non-serious. 1

Skin eruptions and headaches were the most frequently reported ADRs to antihistamines. 1

In addition, problems associated with the central nervous system were also reported, including: 1

  • Aggression
  • Hyperactivity
  • Agitation
  • Somnolescence
  • Seizures.

A strength of this study is that all paediatric ADR reports on systemic antihistamines in the Netherlands Pharmacovigilance Centre Lareb Database were included. 1Using a voluntary spontaneous reporting database means that reporting will occur only when correlation of a drug to the reported ADR is suspected. 1However, the causality is not always certain. 1

The authors concluded that physicians should be aware of these possible ADRs when prescribing second-generation antihistamines. 1

Reference list

  1. de Vries TW, van Hunsel F. Adverse drug reactions of systemic antihistamines in children in the Netherlands. To be published in J Arch Dis Child. [Preprint] 2016.