According to a Dallas Morning News investigation in 2015, a dental patient dies nearly every other day in the United States.
This reminder follows a report received by the Centre for Adverse Reactions Monitoring (CARM) concerning a three-year-old child who was given chlorphenamine for a lower respiratory tract infection and experienced a serious neurological disorder.
The most common adverse effects with sedating antihistamines are sedation, dizziness and incoordination.
However, paradoxical stimulation ranging from excitation through to tremors, hallucinations and convulsions may occur.
Table 1 summarises the proposed warning statement changes regarding use of sedating antihistamines that are available without prescription.
The additions are in red and the deletions are with strikethrough.
This was considered at the 58th MCC meeting on , but was not implemented.Minutes of the 58th MCC meeting Document released for consultation on 2 August 2017.Interested parties should respond by close of business 29 September 2017.Medsafe is seeking comments and input from interested parties on the proposed changes to the labelling requirements for sedating antihistamines that are available without a prescription and a suitable target date for implementation.At the 166th Medicines Adverse Reactions Committee (MARC) meeting on 29 June 2016, the MARC recommended that Medsafe updates the Label Statements Database to contraindicate the use of sedating antihistamines in children under 2 years of age for all indications and remove ‘anxiety’ as a condition for labelling requirements.