Yesterday we made the news that Dalsy 20 mg / ml ibuprofen syrup could be omitting some side effects in the package leaflet, following a complaint by Facua. Specifically, it refers to a twilight yellow food coloring called E-110, which in inappropriate doses is related to effects on the motor skills and attention of children.
As expected, and since in almost every house with young children there is a bottle of Dalsy in the medicine cabinet, it is news that worries parents a lot. That is why it is important to know the opinion of experts in this matter. Is it a danger to our children? Pediatricians consider the news to be alarmist and ensure that Dalsy does not represent any risk and remains safe for children..
We must clarify that Facua does not question the concentration of said dye in the syrup compound, but it does consider that should be noted in the leaflet of the medication on all its possible adverse effects. That is why he claims before the AEMPS (Spanish Agency for Medicines and Health Products) that the "negative effects on the activity and care of children" are expressly indicated. Currently, it only indicates that it could cause allergic reactions and asthma.
What do pediatricians say?
According to statements to Xplora Science by Juan Bravo, member of the Medicines Committee of the Spanish Association of Pediatrics, the dose of E-110 contained in the drug, “It does not represent a risk to children's health. The Spanish Association of Pediatrics continues to recommend it”.
Still, he adds: "It is well to call attention to this and that the authorities analyze not only the active substance of medicines, but also excipients and additives".
What is the safe dose of E-110 dye?
The E-110 dye contained in the Dalsy is also used to make foods such as apricot jams, cookies and pastry products, instant soups, chocolate milkshakes, flour flour and margarines. Food safety regulatory agencies have very demanding controls and constantly review consumption recommendations.
The Admissible daily intake (ADI) of the E-110 dye is 4 mg / kg / day under the directives of the European Union and FAO, as reconsidered by the EFSA (European Food Safety Authority) in June 2014. In 2009, the daily allowable intake was 2.5 mg / kg / day to 1.0 mg / kg / day, but was later raised when it was found safe.
For its part, as we see in the package leaflet, Dalsy contains 0.1 mg / ml of E-110
We give as an example a child weighing 10 kg (between one and three years, approximately). If the syrup contains 0.1 mg / ml and the child takes 5 ml 3 times a day, a total of 15 ml per day, it would be equivalent to taking 1.5 mg / day, when the maximum recommendation for that child would be 40 mg / day.
To give you an idea, as pediatricians Lucia, my pediatrician and Angel Merino say in these tweets, a 10-kilogram child should drink 400 ml of Dalsy to match the maximum intake. The equivalent of two bottles of syrup per day (the bottle contains 200 ml), a dose that would cause poisoning by ibuprofen itself.
@luciapediatra @gmcolli @jramonfernandez exactly 40 ml of the syrup of 20 mg / ml or 800 mg per kg / day to reach the daily limit of E-110
- Ángel Hernández (@angel_h_merino) September 19, 2016
In case of any doubt, Dr. Gloria Colli also clarifies it in her blog and Boticaria García, who ensures that Dalsy remains safe.
The effects of dye E-110 should be included
Even so, beyond the controversy arisen, it is true that the leaflet only warns of the risk of allergy omitting other possible health effects, when you should do so.
Regulation (EC) 1333/2008 of the European Parliament on food additives states that foods that use the E-110 dye, as well as other dyes, should include it with this additional information: "It can have negative effects on the activity and attention of children".
Although we should always take into account the recommended dose, it is important that parents be well informed by pharmacists about the medications we administer to our children, especially those given as frequently as is Dalsy ibuprofen syrup.
