Home Covid Idrossiclorochina effetti collaterali, l’EMA: “Aggiornare informazioni”

Idrossiclorochina effetti collaterali, l’EMA: “Aggiornare informazioni”


Idrossiclorochina effetti collaterali – Le dichiarazioni dell’EMA sugli effetti collaterali di idrossiclorochina e clorochina. Le ultime notizie sul Covid aggiornate in tempo reale.

In seguito all’ultima riunione del Comitato di valutazione dei rischi per la farmacovigilanza (PRAC) dell’Ema, l’European Medicines Agency, gli esperti hanno raccomandato di aggiornare le informazioni sul prodotto per tutti i medicinali contenenti clorochina o idrossiclorochina.

L’indicazione è arrivata a seguito di una revisione di tutti i dati disponibili che hanno confermato un collegamento tra l’uso di questi medicinali e il rischio di disturbi psichiatrici e di comportamento suicidario. “La revisione è stata avviata nel maggio 2020 dopo che l’Ema era stata informata dall’agenzia spagnola dei medicinali (Aemps) di sei casi di disturbi psichiatrici in pazienti con Covid-19 a cui erano state somministrate dosi di idrossiclorochina superiori a quelle autorizzate, si legge in una nota diffusa propria dall’Ema.

Idrossiclorochina effetti collaterali, la spiegazione

In particolare, spiegano gli esperti, la clorochina e l’idrossiclorochina sono autorizzate nell’Unione Europea per il trattamento di alcune malattie autoimmuni. Tra cui l’artrite reumatoide e il lupus, oltre che per la profilassi e il trattamento della malaria.

Non sono autorizzati per il trattamento di Covid-19, ma entrambi i medicinali sono stati utilizzati come trattamento off-label in pazienti con la malattia. Tuttavia, la clorochina e l’idrossiclorochina non hanno mostrato alcun effetto benefico nel trattamento di Covid-19 in ampi studi clinici randomizzati”, ribadisce ancora l’Ema nella nota. Proprio in virtù del loro utilizzo durante la pandemia di coronavirus, ad aprile e maggio scorsi l’Ema aveva ricordato agli operatori sanitari i rischi legati a questi medicinali. “E’ noto che la clorochina e l’idrossiclorochina, anche utilizzate a dosi approvate per indicazioni autorizzate, possono causare un ampio spettro di disturbi psichiatrici”, spiegano dall’Ema.

I disturbi psicotici e il comportamento suicidario sono elencati nelle informazioni sul prodotto di alcuni medicinali contenenti clorochina o idrossiclorochina come effetti collaterali rari o effetti collaterali. Che si verificano con una frequenza sconosciuta”, si legge ancora. In base a ciò, la revisione “ha confermato che si sono verificati disturbi psichiatrici e possono talvolta essere gravi,. Sia in pazienti con che senza precedenti problemi di salute mentale. Sulla base dei dati disponibili, la revisione ha mostrato che, per l’idrossiclorochina, gli effetti collaterali possono verificarsi nel primo mese dopo l’inizio del trattamento. Per la clorochina, non c’erano dati sufficienti per stabilire un calendario chiaro“, hanno chiarito ancora gli esperti.

Le indicazioni per i pazienti

Nell’ottica di queste valutazioni, il PRAC ha dunque fortemente raccomandato di “aggiornare le informazioni sul prodotto per questi medicinali per fornire migliori informazioni agli operatori sanitari. Ed anche ai pazienti sul rischio di comportamento suicidario e disturbi psichiatrici”.

In particolare, secondo gli esperti dell’European Medicines Agency, tutti i pazienti che assumono medicinali a base di clorochina o idrossiclorochina e che manifestano problemi di salute mentale, tra cui “pensieri irrazionali, ansia, allucinazioni, sensazione di confusione o depressione, inclusi pensieri di autolesionismo o suicidio, o altri intorno a loro che notano questi effetti collaterali, devono contattare un medico immediatamente“.


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