Children's medicine prospectus does not mention colourant E-110 side-effects, warns consumer group
Children's medicine prospectus does not mention colourant E-110 side-effects, warns consumer group
CONSUMER organisation FACUA has warned that the side-effects of colourant E-110 'sunset yellow' have not been included in the prospectus of a painkiller medicine for children.
Dalsy, a mild Ibuprofen solution targeting pain and fever in children aged from three months to 12 years, contains the yellow colour E-110 but does not mention its possible adverse effects as required by European Union Regulation CE 1333/2008.
Side-effects sometimes, although rarely, seen as a result of the 'E-number' included relate to the child's 'psycho-motor capacity', says FACUA – which, roughly translated, can cause 'negative effects' on young patients' 'attention ability and activity'.
In other words, E-110 can make children excessively hyperactive, or the reverse – hypoactive.
Whilst FACUA does not warn against the use of E-110, it has warned that all additives, excipients and main ingredients in medication must be clearly labelled and possible allergic reactions, contraindications and adverse effects mentioned in the paperwork inside the packaging.
FACUA has urgently alerted the Spanish Agency for Medicine and Healthcare Products (AEMPS), which confirms it has received the report and is studying it in accordance with its standard procedures.
AEMPS wished to clarify that there is 'no cause for alarm'.
In the meantime, parents who are concerned may wish to research the side-effects E-110 very occasionally has on children from babyhood to 12 years old, especially if their child suffers from a hyperactivity disorder.
