FACUA-Consumidores en Acción , a non-profit association created to defend consumer rights, and a reference in Spain, has made a request to the AEMPS (Spanish Agency for Medicines and Health Products) indicating that the medicine for children Dalsy omits in its leaflet the possible side effects of one of the substances that it contains, specifically, the colorant E-110 . This news has raised some alarm about the possible side effects of Dalsy, but the same association reassures parents that the amount used does not pose a danger, but that it is necessary to fully warn and report any effect that it could cause.
WHAT IS THE DALSY
The drug Dalsy 20 mg / ml oral suspension is a syrup whose active ingredient is ibuprofen, which belongs to the group of NSAIDs , or Non-Steroidal Anti-inflammatory drugs. It is used in children between 3 and 12 years old when they have mild or moderate pain or if they have a fever , just like adults we take ibuprofen for the same type of ailments.
WHAT IS E-110 DYE AND WHAT EFFECTS CAN IT HAVE?
E-110 is a yellow-orange food coloring that gives Dalsy its appearance and helps children want to drink it when they are sick. As indicated by FACUA, collected from Regulation (EC) 1333/2008 of the European Parliament on food additives, high amounts of this product can have negative effects on the activity and attention of children . The Dalsy package insert warns that E-110 can cause allergic reactions or asthma , especially in people allergic to acetylsalicylic acid , but not that it can affect children in any other way.
However, this does not mean that Dalsy is dangerous or affects children because it contains this dye. FACUA does not consider its use harmful , since it complies with the permitted amounts, however, as it is a possible risk, it must be mandatory that it appear on the prospectus.
ARE THERE REASONS TO WORRY?
Thus, FACUA’s request is that this information be included in the prospectus, and the Ministry of Health is studying the case, as is done in all similar cases, to carry out all the necessary actions so that finally, the side effects in the drug leaflet . However, they emphasize that it is not an alarming issue.
As parents, we have no reason to worry and we can continue to give this medicine to our children if our pediatrician has prescribed it, or if it has not caused any side effects in the past.