Come ogni anno ecco i dati sulle segnalazioni dell’anno precedente che mostrano un ulteriore passo avanti nel momento in cui esce finalmente il nuovo decreto sulla farmacovigilanza
Quando, lo scorso ottobre, avevo scritto un editoriale per Focus Farmacovigilanza (Focus nov-dic 2014, pagina 1) sulla “eccezione Ebola” riguardo alle regole per la valutazione sulla sicurezza ed efficacia dei farmaci, non avrei mai immaginato che di lì a pochi giorni mi sarei trovato coinvolto personalmente nella questione, e così a fondo da esserne quasi completamente assorbito negli ultimi sei mesi.
New warning added to drug label to describe risk of chemical leukoderma.
chemical leukoderma, have been associated with the use of the Daytrana patch.
Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
FDA will update recall with new information as it becomes available.
Can cause serious adverse health issues including allergic reactions, pain, infections, or death.
The bulletin “Focus Farmacovigilanza” has always been particularly sensitive to the conflict of interest issue, to the point of reporting to the reader even the possible conflicts concerning the sources used in the various articles. It’s worth reminding that “Focus Farmacovigilanza” is not a journal that publishes original research articles or reviews, but a bulletin that disseminates news and comments in the field of pharmacovigilance. It is therefore a tertiary literature journal aiming to disseminate medical-scientific information.
An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.
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