Antihistamines are class of medications which are commonly used in getting relief from allergic symptoms. The most common therapeutic/adverse effect produced by antihistaminergic drugs is drowsiness (sleepiness). These sedating antihistaminic drugs are available as over the counter (OTC) medicine category and can be used for a range of conditions in both adults and children.

MedSafe, New Zealand health authority released a safety update for restricting the use of medicines belonging to the antihistaminic therapeutic class in paediatric group of population for ‘sedation’ as the therapeutic indication. This restricted use has recommended due to lack of safety data in this special group of population (age group <18 years) for this indication.

Medicines Adverse Reactions Committee (MARC) advised healthcare professionals, parents and children careproviders to be aware of this safety information before choosing the oral antihistaminic medicines from OTC outlets for sedating their children. They should be referred to medical practitioner for specific benefit risk evaluation of medicine before use with respective to individual child’s medical condition.

However, the use of oral antihistamines for all other therapeutic indications (other than sedation) remains unchanged. Oral promethazine-containing medicines are predominantly affected by this safety update.

The production information documents (data sheets and product packaging) for promethazine-containing medicines are being updated to reflect this recommendation, so that the use of this medicines for sedation is indicated for adults only.

Healthcare professionals and consumers are advised to be aware of this new safety information (recommendation for restricted use of oral antihistamines in children for sedation purpose), since it would require some time to get this information reflected/updated in the product information documents.

Voluntary ADR reporting

Every medicinal product has both benefits and risks. There is no single pharmaceutical product which is completely free from side effects/adverse reactions. All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority. This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety.

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