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Mucolytics contraindicated in children under 2 years: the note AIFA

quote in full the AIFA important note regarding the contraindication to the use of mucolytics in children under 2 years of age

Dear Doctor, Dear Doctor,

Office di Farmacovigilanza dell’ Agenzia Italiana del Farmaco (AIFA) ha condotto una revisione di sicurezza dell’intera classe dei mucolitici per uso orale e rettale.

I principi attivi coinvolti sono stati: acetilcisteina, carbocisteina, ambroxolo, bromexina, sobrerolo, neltenexina, erdosteina e telmesteina , contenuti in numerosi medicinali che sono per la maggior parte dispensabili senza obbligo di ricetta.

Questi farmaci hanno attività mucolitica e fluidificante e sono per lo più prescritti, o somministrati dal genitore, nel trattamento delle affezioni acute e croniche dell’apparato respiratorio.
Un’analisi dei dati francesi di farmacovigilanza ha messo highlighted an increase in cases of respiratory obstruction and worsening of respiratory diseases in children under 2 years and receiving mucolytics. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract.
reported adverse reactions occurred primarily affecting the respiratory system (worsening of bronchiolitis, increased cough, increased bronchial secretions, wheezing, difficulty breathing, vomiting viscous), were for the most serious and required the ' hospitalization. The risk of these adverse reactions and the absence of efficacy data for pediatric in acute bronchial diseases, has led France to contraindicate the use of mucolytics in children under 2 years of age.

The AIFA, after reviewing the safety data available mucolytics the country, there are few data to support the effectiveness of these drugs in children under 2 years and on the basis of French data, adopted a restrictive measure, currently under implementation, to prohibit the use of mucolytics, oral and rectal use in children under 2 years.
This measure involves the introduction in the Summaries of Product Characteristics and Package Leaflet of the following changes:

- controindicazione all’uso nei bambini di età inferiore ai 2 anni;

- avvertenza sul rischio di ostruzione bronchiale nei bambini di età inferiore ai 2 anni;

- inserimento del termine “ostruzione bronchiale” nel paragrafo “Effetti indesiderati”, qualora la segnalazione di tale reazione avversa sia stata riportata.

Il paragrafo “Posologia e modo di somministrazione” sarà aggiornato di conseguenza, laddove necessario.
Si precisa che la controindicazione non riguarda l’uso antidotico dei medicinali contenenti acetilcisteina.
A seguito dell’introduzione della controindicazione, le confezioni a base di sobrerolo e ambroxolo, dedicated exclusively to children younger than 2 years shall be subject to revocation.

It is therefore considered necessary to draw the attention of general practitioners, pediatricians and pharmacists telling them that:

- mucolytics are prescribed or recommended always after careful evaluation of the benefit / risk of each patient and never in children under 2 years of age;

- to inform / educate parents on the proper management of cough, appropriate use of mucolytics and the availability of alternative therapies in children;

- pharmacists to make this possible risks and contraindications below 2 years of the parent who requires a mucolytic in order to prevent improper use of children in that age group. The AIFA

take this opportunity to remind all doctors and pharmacists of the importance of reporting suspected adverse drug reactions, as an indispensable tool to confirm a favorable risk benefit ratio in the real conditions of use. The
this Information is also posted on the AIFA, which is recommended for regular consultation with the best information and professional service to the citizen.

This Information paper prepared by the AIFA, covers all medicinal products for oral and rectal containing acetylcysteine, carbocysteine, Ambroxol, bromexina, sobrerol, neltenexina, and erdosteina telmesteina, regardless of their mode of delivery and was distributed by the National Association of Pharmaceutical Industry of self-medication (Anif), and by Assogenerici Farmindustria .

The Office of the Italian Drug Pharmacovigilance

V.bernardelli , How Much

laugh and it will pass . Scientific research between smiles and tears

While in early October in Stockholm was awarded the Nobel Prize, Harvard University took place the ceremony of IgNobel , dubbed "the Nobel of the absurd." Every year - from 1991 to this part - the Improbable Research with its namesake magazine Annals of Improbable Research award recognition to those researchers who, with their publications "first make people laugh and then think" to "celebrate the unusual, honor the imaginative and stimulating people's interest in science, medicine and technology." IgNobel This year's prize for medicine went to two Dutch, Simon Rietveld and Ilja van Beest, who discovered that asthma symptoms can be treated with the mountains Russian . It would seem the joke of a joker, but it's really true. Type in PubMed believing. : Rietveld S, van Beest I. Rollercoaster asthma: when positive emotional stress interferes with dyspnea perception . Behave Res There. 2007; 45:977-87. All this seems even more absurd when you consider that this research (conducted on 25 women with severe asthma and of course a control group of 15 subjects) was financed by two agencies, the Netherlands Asthma Foundation and the Netherlands Organization for Scientific Research. Just out of curiosity, in this study the stress was induced by repeated turns on a roller coaster. The results showed that negative emotional stress and blood pressure have reached their peak just before the roller coaster ride, while positive emotional stress and heart rate immediately after. Furthermore, "dyspnea in women with asthma was higher just before the race compared to just after, even in subjects where there was a reduction in lung function induced by its own roller coaster." The authors conclude that "patients with chronic asthma if they tend to perceive stress and stimulates the association acquired in terms of dyspnea, wheezing, and families between positive or negative moods, promoting or under-perception or over-perception of dyspnea, depending on the emotional valence of a situation. " Translated in simple terms: if an asthmatic like roller coasters, you forget all her body a bit 'of his dyspnoea ...

Gianluca Tornese

Pediatrics

IRCCS "Burlo Garofolo", Trieste

Read the complete editorial published in the December issue of Medical and Child

laugh and it will pass. Scientific research between smiles and tears

Medical and Child 2010, 29:551-552

See also : Improbale research

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Physicians retire in the next 10 years

About 4 out of 10 doctors over the next dieci anni, andranno in pensione . A svestire il camice bianco saranno infatti 115 mila medici, oggi compresi nella fascia di età tra i 51 e i 59 anni, ovvero il 38% di tutta la popolazione medica attiva. Tra questi sono compresi il 48% dei medici dipendenti dei servizi sanitari regionali e Università, il 62% dei medici di famiglia, il 58% dei pediatri di libera scelta, il 55% degli specialisti convenzionati.

A scattare la fotografia è la Federazione nazionale degli Ordini dei medici (Fnomceo), nel corso della II Conferenza nazionale della professione medica, oggi a Roma.Secondo la Fnomceo, dall'analisi dei dati emerge chiaro un aspetto: "la formazione dei futuri camici bianchi è una vera emergenza, for which is an ad hoc project, effective, first requires that greater connectivity and flexibility in reports and 'rules of engagement' between the faculty of medicine and public and private accredited regional health services. "It is a project the Fnomceo is working to bring the new recruits to 'move with the times'. "The new doctor - says White - because of the extraordinary development of medical science as technological needs more tools to handle these unique resources. Which are expensive and have a number of problems, such as the appropriateness of their use. "For the president of Fnomceo, this scenario poses a series cascade other problems: the selection of access, the training content, training of specialists. That's why - he explains - we a number of proposals, which we believe redefine a training model that sees a strong integration between the traditional activity Universities and training activities of the NHS. " Universities and NHS, for White "must experience a moment of strong cooperation to overcome the emergency in quality".

Fnomceo The project is based on an integrated and continuous process that starts from access to medical studies at the end of professional activity. "It must be measured - White points out - not only with the evolution of technical and scientific knowledge, but also with the new definitions, new horizons and different cultural legitimacy and civil constantly reshape the goals of medicine and healthcare. "

not only university education, therefore, but also post-graduate training." In our system - White said - is unfortunately lagging behind a culture of promotion and evaluation of the quality of professionals and services. A critical thinking that would be wrong and counterproductive to resolve addressing them from the queue through the unique enhancement patterns of bureaucratic control and sanction inquisitors.

For Fnomceo, to train the doctors of the future, a key role to be played dalle Società medico scientifiche. "Realizzando al più presto - spiega il presidente Bianco - un modello di accreditamento istituzionale, così da garantire il loro riconoscimento in ruoli di interlocutori stabili, affidabili e autorevoli delle istituzioni sanitarie". Per Bianco, "lo stesso nuovo sistema di Educazione continua in medicina (Ecm) può, in prospettiva, offrire al bisogno di formazione continua dei medici e di tutti i professionisti sanitari non un frammentato e disorganico universo di soggetti a vocazione formativa, non sempre trasparenti, efficaci ed indipendenti, ma solo provider in grado di garantire lo sviluppo e la continuità di un sistema formativo affidabile e calibrato sulle esigenze dei singoli professionisti and organizations in which they operate. "

Source: Reuters Health

Red Tinged Cervical Mucus Before A Period

Recommendations of the Working Group on the use of Pediatric AIFA Fans

part of the monitoring of reports of suspected adverse reactions in recent years, shows a progressive increase in the number of reports of suspected adverse reactions to NSAIDs in children

The Pediatric Working Group AIFA intensified the argument and issued recommendations on.

See the article open access published in the December issue of Child and Medical

Cautions on the use of NSAIDs in children
Paediatric Working Group AIFA
Medical and Child 2010, 29, 654-6