Cough and cold medicines containing antihistamines, antitussives, decongestants and expectorants will no longer be licensed for children under the age of two years in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
The MHRA said there would also be additional warnings on packaging for such medicines aimed at children aged 2-6 years.
Most products authorised for children under six can remain on the market, pointed out the MHRA, but updated versions must be introduced as soon as possible in the next six months.
The move comes soon after the Food and Drug Administration (FDA) in the US decided that non-prescription cough and cold medicines should no longer be used for children under the age of two years.
The OTC industry in the US voluntarily withdrew oral cough and cold medicines for infants under two years of age in October of last year (OTC bulletin, 31 October 2007, page 1).
A safety review in the US revealed a number of serious reports, mainly involving children being given too much medicine because parents or caregivers had been confused about the correct dose or being given more than one product containing the same active ingredient.
No comments:
Post a Comment