Published: 1 September 2016

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MARC's Remarks: June 2016 Meeting

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Prescriber Update 37(3): 46
September 2016

The Medicines Adverse Reactions Committee (MARC) met on 29 June 2016 to discuss a number of medicine-related safety issues.

The MARC discussed the use of dexchlorpheniramine and other sedating antihistamines in children. The MARC recommended that the use of sedating antihistamines should be restricted according to age and indication as follows.

• Contraindicated in children under two years of age for all indications.
• Remain contraindicated in children under six years of age for the treatment of cough and colds.
• Contraindicated in children under 12 years of age for the treatment of insomnia.
• Available as prescription medicines when used in children under six years of age for nausea and vomiting and for travel sickness.

The MARC reviewed the current sedation warning and available evidence on the sedating effects of loratadine- and desloratadine-containing products. The MARC considered that a warning should remain for these non-sedating antihistamines but be amended to reflect the low risk of sedation.

The MARC reviewed the available evidence around the use of tramadol in children. The MARC recommended that Medsafe request the sponsors of tramadol-containing products to add a contraindication in children under two years of age and update the warnings and precautions section of the medicine data sheets.

The MARC reviewed the available information on the risks of chronic kidney disease and dementia with proton pump inhibitors. The MARC concluded that the evidence was insufficient to support an association for either of these risks.

Read further information on the 166th meeting held on 29 June 2016 at www.medsafe.govt.nz/profs/adverse/Minutes166.htm