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L’Agenzia Europea dei Medicinali raccomanda restrizioni d’uso per i medicinali a base di tiocolchicoside per uso orale e iniettabile.
| Posted on December 3, 2013 at 9:43 AM |
Tiocolchicoside è un rilassante muscolare autorizzato
con procedura nazionale in diversi Stati membri dell'UE(Italia,
Repubblica Ceca, Francia, Grecia, Ungheria, Malta, Portogallo e Spagna) per uso orale o intramuscolare nel trattamento di patologie
muscolari dolorose. Il Comitato per
i prodotti medicinali per uso umano (CHMP) dell'Agenzia Europea dei Medicinali
ha raccomandato restrizioni agli usi autorizzati dei medicinali a base di
tiocolchicoside per uso orale o iniettabile in tutta l'Unione europea (UE).
Questi medicinali sono oggi raccomandati solo come trattamento addizionale per
contratture muscolari dolorose (contrazione permanente del tessuto muscolare)
derivanti da condizioni patologiche della colonna vertebrale in adulti e
adolescenti di età superiore a 16 anni. Inoltre, la dose di tiocolchicoside per
bocca o per iniezione deve essere limitata. La rivalutazione dei medicinali a base di
tiocolchicoside è stata avviata su richiesta dell’Agenzia Italiana del Farmaco
(AIFA) a seguito di nuove evidenze sperimentali che suggerivano che il
metabolismo di tiocolchicoside desse origine nell’organismo ad un
metabolita, il quale può causare danni
alle cellule in divisione causando aneuploidia (cioè un numero o una
disposizione di cromosomi anormali). Di conseguenza, l’AIFA ha chiesto al CHMP di esaminare
il profilo di sicurezza del medicinale e di considerare quali azioni
regolatorie intraprendere. Il CHMP ha riesaminato le evidenze, compresi i pareri
di esperti nel campo della sicurezza dei medicinali, e ha concluso che
l’aneuploidia potrebbe verificarsi con il metabolita a livelli non molto
superiori a quelli osservati dopo somministrazione delle dosi raccomandate di
tiocolchicoside per via orale. Ricordiamo che l’aneuploidia è un fattore di rischio
per danni al feto in corso dii sviluppo, per riduzione della fertilità maschile
e, in teoria, potrebbe aumentare il rischio di sviluppare il cancro. Il CHMP ha raccomandato pertanto che siano messe in
atto misure per garantire che i medicinali a base di tiocolchicoside siano
utilizzati nel modo più sicuro possibile. Queste includono la limitazione della
dose massima e del numero di giorni di trattamento quando somministrati per via
orale o intramuscolare. L'uso è inoltre controindicato in gravidanza e
allattamento o in donne in età fertile che non utilizzano contraccettivi, così
come nei bambini o per il trattamento di malattie croniche (a lungo termine). Le formulazioni ad uso locale sulla pelle, che non
danno origine a livelli rilevanti del metabolita nell’organismo, non sono
interessate da questa rivalutazione. Informazioni per i pazienti • Tiocolchicoside è un medicinale utilizzato in alcuni
paesi dell'UE per condizioni patologiche associate a dolore muscolare. • Nuove evidenze hanno dimostrato che tiocolchicoside è
trasformato nell’organismo in una sostanza chiamata M2, che a determinate
concentrazioni può influenzare il materiale genetico delle cellule. Ciò si
traduce in un numero anomalo o in una disposizione anomala dei cromosomi, che
può ridurre la fertilità negli uomini e, se avviene durante la gravidanza, può
danneggiare lo sviluppo del bambino nel grembo materno. In teoria,
l'esposizione a lungo termine potrebbe aumentare il rischio di cancro, anche se
non esiste attualmente alcuna prova. • Per minimizzare la quantità di M2 prodotto
nell’organismo, e pertanto eventuali rischi associati, i medicinali a base di
tiocolchicoside sono ora raccomandati solo per uso a breve termine, in aggiunta
ad altri trattamenti, per il dolore dovuto alla contrazione permanente dei
muscoli, causata da problemi alla colonna vertebrale, in adulti e adolescenti a
partire dai 16 anni di età. • Il trattamento deve essere limitato a 7 giorni per
bocca o a 5 giorni per iniezione intramuscolare. Per pazienti che stanno
assumendo tiocolchicoside per una condizione patologica a lungo termine, il
medico rivaluterà il trattamento nel successivo appuntamento programmato. • I medicinali a base di tiocolchicoside non devono mai
essere assunti in caso di gravidanza o in allattamento. Le donne in età fertile
devono usare metodi contraccettivi durante l'assunzione di questi medicinali. • I medicinali a base di tiocolchicoside sono
disponibili anche per l'applicazione sulla pelle, ma questi ultimi non danno
origine agli stessi livelli di M2 nel organismo e non si ritiene che abbiano
effetto sul materiale genetico o sulle cellule. Pertanto, queste
raccomandazioni non riguardano tali medicinali. • I pazienti che hanno qualsiasi domanda possono
rivolgersi al proprio medico o al farmacista. |
Categories: MEDICINA
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