L'agenzia britannica per il controllo dei farmaci (Commission on Human Medicines, CHM) ha reso nota una serie di provvedimenti per aumentare la sicurezza d'uso di alcuni medicinali contro tosse e raffreddore in bambini al di sotto dei 12 anni.
La Medicines and Healthcare products Regulatory Agency (Mhra) ha pubblicato una lista di 36 farmaci, tra cui molti sciroppi e alcune capsule, che non dovrebbero essere somministrate ai bambini di età inferiore a 6 anni e ha annunciato che i dosaggi per i bambini tra i 6 ed i 12 anni verranno aggiornati alla luce del riesame. I principi attivi contenuti dalle medicine elencate dalla Mhra sono: i calmanti della tosse destrometorfano e folcodina, gli espettoranti guaifenesina e ipecacuana, i decongestionanti efedrina, pseudoefedrina, ossimetazolina, fenilefrina e xilometazolina e gli antistaminici bromfeniramina, clorfenamina, difenidramina, doxilamina, prometazina e triprolidina.
Le nuove indicazioni avvisano i medici e i genitori di non utilizzare questi OTC per tempi prolungati in bambini con meno di 6 anni: non ci sono evidenze a sostegno della loro efficacia e in alcuni casi possono provocare effetti collaterali, come reazioni allergiche, problemi al sonno o allucinazioni. Per i bambini tra i 6 ed i 12 anni questi farmaci restano a disposizione, ma saranno venduti solo nelle farmacie, con chiare avvertenze sul foglietto illustrativo e da parte del farmacista. Questo perché il rischio nei bambini più grandi è inferiore, in quanto il loro peso è maggiore, si ammalano meno facilmente e possono comunicare l'eventuale effetto benefico del medicinale.
Le aziende stanno aggiornando confezioni e foglietti illustrativi dei farmaci per tosse e raffreddore autorizzati per l'uso in bambini con meno di 6 anni, inserendo le nuove avvertenze. In ogni caso, questi prodotti dovrebbero essere somministrati con attenzione, seguendo le istruzioni di assunzione per dosaggio e posologia.

PRESS RELEASE: BETTER MEDICINES FOR CHILDREN'S COUGHS AND COLDS
28 Feb 2009
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced today a comprehensive package of measures to promote the safer use of over-the-counter (OTC) cough and cold medicines for children under 12 years old. This follows the MHRA's thorough review of the benefits and risks of these medicines.
On advice from the Commission on Human Medicines (CHM), the new package represents a proportionate move to improving the balance of risks and benefits for these medicines. People using these products for children, or have used them in the past, do not need to worry. Neither do shelves need to be cleared.
The MHRA review did not identify in this age-group the safety issues of the kind which prompted our action in under-2s in March 2008. But the review found no robust evidence that these medicines work and they can cause side effects, such as allergic reactions, effects on sleep or hallucinations.
Parents and carers should no longer use OTC cough and cold medicines containing the ingredients reviewed in children under 6. They should follow advice to relieve symptoms as outlined in the Department of Health's 2007 guidance 'Birth to Five'. For 6 to 12 year olds these medicines will continue to be available but will only be sold in pharmacies, with clearer advice on the packaging and from the pharmacist. This is because the risks of side effects is reduced in older children because they weigh more, get fewer colds and can say if the medicine is doing any good. More research is being done by industry on how well these medicines work in children aged 6-12 years.
MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said, "Coughs and colds can be distressing for both you and your child but they will get better by themselves within a few days. Using simple measures to ease symptoms is likely to be most effective.
"Over-the-counter medicines used to treat coughs and colds have been used for many years. However they came into use when clinical trials were not required to demonstrate that they worked in children. This means they were not specially designed for children.
"It is not right to assume safety and efficacy based on children being 'small adults'. Children should have access to medicines that are acceptably safe and designed for their use."
The MHRA is working with industry and healthcare professionals to encourage 'best practice' and implement these measures. Industry has agreed to implement changes over a period of time. They will make the necessary labelling changes to state that these medicines should not be used in children under 6, introduce updated labelling, and to change the legal status of medicines authorised for children aged 6 - 12 years from general sale (GSL) to pharmacy (P). Newly labelled products will start to appear for the 2009 cough and cold season. Medicines with the old labelling will not be cleared off shelves. This is because many of these products are used in adults and children, and so cannot be withdrawn, creating a shortage of these medicines. Withdrawing these medicines would not be proportionate compared to the risk of side effects. These changes should be completed by March 2010.