The consumer association FACUA has announced today that it has contacted the Spanish Agency for Medicines and Health Products (AEMPS) in order to notify that Ibuprofen syrup 'Dalsy' 20 mg / ml, which is given to babies since they are three months old, could be omitting in its leaflet side effects related to psychomotor capacity.
As we read on the FACUA page, the medicine contains a dye, the E-110, which gives the particular orange appearance to the preparation, which according to Regulation (EC) 1333/2008 of the European Parliament on food additives can cause in some cases "negative effects on the activity and attention of children".
In the leaflet they only comment in case there is an allergy
In the Dalsy leaflet it is stated that said dye could cause allergic reactions and asthma:
Dalsy contains orange yellow dye S (E-110). May produce allergic reactions. It can cause asthma, especially in patients allergic to acetylsalicylic acid.
This explanation omits what the Regulation of the European Parliament refers to with respect to the coloring, and therefore FACUA considers that every person who can administer the syrup to a child you should be aware that it could affect you in that regard.
The dose may be insufficient to cause side effects.
The statement makes it clear that although the manufacturer (Abbott) does not specify that side effect, it is assumed that the amount of E-110 dye is within the allowed parameters. However, despite this, FACUA believes that this data on the effect that such dye can have should be specified within the leaflet.
Dye E-110 "Twilight Yellow"
He E-110 It is a food coloring that is present in jams such as apricot, cookies, pastries, soups, chocolate milkshakes, margarines, bag fries, etc. Its basic function is the to give orange color to food.
Some studies (The Lancet he talked about it in 2007) they relate it to hyperactivity, so that the maximum daily amount that is recommended to consume was established in 2009, changing downwards, in 2.5 mg / kg at 1.0 kmg / kg. In Norway its use was banned years ago.
The big question is why a syrup takes it in its composition, if it has possible side effects (nor is it the risk of allergy, it is enough to consider it). To contrast we have looked for the dye in other ibuprofen syrups for children such as Junifen and the generic Ibuprofen Cinfa and they do not contain it in their composition.
