HeDalsyIt is not the first children’s pharmaceutical to be targeted by consumers, parents and doctors. Several medications have had to be recently removed or restricted after having reached the medicine cabinets of Spanish homes.
We reviewed some medicines for children that were not neither so effective nor so innocuous as their prospectuses said.
ibuprofen
Last year the Spanish Agency for Medicines and Health Products (AEMPS) withdrew a batch from the ibuprofen Kern Pharma, of Farmasierra Manufacturing. He took the measure for an “out of specification result” detected in routine checks. In these studies, the syrup presented a number of yeasts above the limitalthough the company assured that “they are yeasts that are not pathogenic or harmful for human consumption.”
In January 2013, the Ministry of Health also halted the sale of a lot of the Junifen syrup (whose active ingredient is also ibuprofen), specifically G07. It was only justified as a “precautionary measure”.
Codeine
Also in 2015, the use of codeine-containing medicines to relieve mild or moderate coughs in catarrhal processes was limited. Health prohibited its intake to children under 12 years of age and lactating women, since the side effects can be very serious in children who metabolize this pain reliever in large amounts or quickly. Several serious cases had previously been detected, some fatal, of minors who had suffered morphine poisoning after taking codeine.
suppositories with terpenes
Its efficacy against coughs and bronchial conditions has not been fully demonstrated, and yet the risk that it may induce seizures and epilepsy it is elevated. These plant derivatives are marketed as suppositories through brand names such as Pilka and Sproutcontraindicated in children under 30 months.
metoclopramide
Contained in the known primperan against vomiting, this compound was discouraged three years ago in children and adolescents, while it was contraindicated in children under one year of age both by the Spanish Agency and by its European counterpart due to its high risk of causing adverse cardiovascular reactions.
Domperidone
For six years, several studies have linked domperidone with the appearance of severe ventricular arrhythmias or sudden cardiac death. It has been marketed in our country under the brands Motilium, Domperidone Gamir and Domperidone Pensa. Since then, the Agency recommends its consumption in children and adults in the lowest possible effective dose. According to some pediatricians, its low impact on the relief of vomiting and its reactions make it a medicine to avoid. The Agency considers, however, that its benefit-risk ratio is favourable.