Published: 6 September 2018

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Changes Regarding the Use of Sedating Antihistamines

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Prescriber Update 39(3): 42–43
September 2018

 

Medsafe sought expert committee advice on sedating antihistamines, resulting in regulatory changes regarding their use.

Medicines Adverse Reactions Committee (MARC)

In June 2016, the MARC reviewed the available information on the indications, contraindications and classifications of sedating antihistamines¹.

The main concerns with using sedating antihistamines in children are the risk of sedation and respiratory depression². The MARC recommended that sedating antihistamines should be contraindicated in children aged under two years³.

The MARC noted that ‘for the treatment of anxiety’ is not an approved indication for use¹ and is therefore not necessary in either the Label Statement Database (LSD) or the Classification Database (the LSD is available at www.medsafe.govt.nz/regulatory/labelling.asp and the Classification Database at www.medsafe.govt.nz/profs/class/classintro.asp).

Medicines Classification Committee (MCC)

In April 2018, the MCC recommended that the statement ‘for the treatment of anxiety’ should be removed from the pharmacist-only (restricted) medicine classification statements for sedating antihistamines⁴.

Label Statements Database (LSD)

The LSD lists the warning and advisory statements that are required on medicine labels under the Medicines Regulations 1984.

The LSD has been updated to include the MARC and MCC recommendations concerning the use of non-sedating antihistamines (Table 1).

Table 1: Label Statements Database entry for sedating antihistamines

Medicine/Group/Class	Conditions	Statements or requirements
Antihistamines, sedating Includes: Alimemazine Brompheniramine Chlorphenamine Cyclizine Dexchlorpheniramine Diphenhydramine Doxylamine Ketotifen Meclozine Mepyramine Pheniramine Promethazine	For oral use	Do not use in children under 2 years old. This medicine may cause drowsiness. Be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine.
	In cough and cold medicines	Do not use in children under 6 years old. Consult a healthcare professional before using in children aged 6 years and over. Do not use with other antihistamines. Do not use with other medicines intended to treat the symptoms of the common cold except on the advice of a healthcare professional.
	For the treatment of insomnia	Do not use in children under 12 years old. Do not exceed the maximum stated dose. This product is for temporary use only. [or] For short term use only. Consult a doctor if sleeplessness persists.

Source: Medsafe. 2018. Label Statements Database Edition 1.22 (August 2018). URL: www.medsafe.govt.nz/regulatory/labelling.asp (accessed 22 August 2018).

References

1. Medsafe. 2016. Medicines Adverse Reactions Committee: Use of oral sedating antihistamines in children. Wellington: Medsafe.
2. Medsafe. 2013. Children and sedating antihistamines. Prescriber Update 34(1): 11–12. URL: www.medsafe.govt.nz/profs/PUArticles/PDF/PrescriberUpdate_March2013.pdf (accessed 25 June 2018).
3. Medsafe. 2016. Minutes of the 166th Medicines Adverse Reactions Committee Meeting 29 June 2016. URL: www.medsafe.govt.nz/profs/adverse/Minutes166.htm (accessed 25 June 2018).
4. Medsafe. 2018. Minutes of the 60th meeting of the Medicines Classification Committee held in Wellington on 26 April 2018 at 9:30am. URL: www.medsafe.govt.nz/profs/class/Minutes/2016-2020/mccMin26April2018.htm (accessed 25 June 2018).