Ukuvunyelwa kwakamuva kwe-FDA kufaka phakathi izidakamizwa zokulutha i-opioid, migraines, MS

Izindaba

Ukuthola imvume yezidakamizwa ku-FDA kufaka inqubo elawulwa kakhulu edinga ukuthi izinkampani ziqedele izivivinyo zamazinga amaningi, zigcwalise izicelo ezahlukahlukene, futhi ekugcineni zidlale umdlalo wokulinda ukuthola ukuthi zingaqhubekela phambili yini ngokuthengisa. Sekukonke, kuthatha cishe iminyaka eyi-10 ukuthi umuthi uthole ukwamukelwa yi-FDA, futhi muva nje imakethe ibone ukuvunywa okusha okuningana okunikeza imiphumela ethembisayo yeziguli ezinezimo ezithile.

I-Lucemyra yokwelashwa kwe-opioid yokulutha

Ochwepheshe bezokwelapha kudala bathembela emithini ethile yokusiza iziguli ezinemilutha yezidakamizwa; noma kunjalo, le mithi yokwelapha ngezinye izikhathi ingaletha imiphumela yayo emibi. Ezimweni eziningi, ama-opioid asetshenziswa njengengxenye ye- ukwelashwa okusizwa yimithi , lapho umuthi uhlangana nezindlela ezahlukahlukene zokwelapha ukusiza abantu ukuthi baphule ukuncika kwabo.

Kodwa-ke, ukusetshenziswa kabi kwe-opioid nokusetshenziswa kabi kudlangile ezweni lonke. Ngo-2016 kuphela, Kushone abantu abangu-116 nsuku zonke ngenxa yokweqiwa kwama-opioid. Ngomzamo wokusiza ngalolu bhubhane, i I-FDA isanda kunikeza imvume ye-lofexidine.

Imakethwa njenge Lucemyra , i-lofexidine yisidakamizwa esenzelwe ukufaka ama-opioid kanye nokuncika okuza nazo njengoba iziguli zihamba ngokuhoxa. Enye yezinzuzo ezinkulu zalo muthi ukuthi wenziwe ngendlela yokuthi abantu bangabi umlutha wawo, futhi kukhonjiswa isithembiso esikhulu kuzilungiselelo zokuhlolwa komtholampilo.

IGilenya yokwelashwa nge-multiple sclerosis

Okunye ukuqhamuka emakethe yezemithi kuza ne I-FDA ukunwetshwa okwandisiwe kwe- Gilenya , umuthi owavunywa okokuqala ngo-2010 ukwelapha abantu abadala abane-multiple sclerosis ebuyela emuva. Ukunwetshwa kuyayivumela ukuthi isetshenziselwe ukwelapha izingane ezineminyaka eyi-10 nangaphezulu ezihlushwa ukubuyela emuva kwe-multiple sclerosis. Yize abantu abaningi betholakala ukuthi bane-MS phakathi kweminyaka engama-20 nengama-50, izingane ezihlushwa yilesi simo zivame ukuthola izinga lempilo elehle kakhulu.

I-Multiple sclerosis ibonakala ngokuqubuka kwezimpawu eziningi (ezinjengobuhlungu, ukundindizela, isiyezi, ukuhamba kanzima, phakathi kwabanye) ezinciphayo zigeleze. Njengesifo esingapheli sokuzivikela komzimba, siphazamisa izinqubo zokuxhumana phakathi kobuchopho bakho nomzimba wakho.

I-Aimovig yokwelashwa kwe-migraine

Abantu abangaphezu kwezigidi ezingama-38 bathinteka yimigraines e-U.S. Ngaphandle kokuqaqamba kwekhanda, abantu abathola imigraines bavame ukuthola ukuthi bazwela ngendlela emangalisayo umsindo nokukhanya, futhi bangaze babhekane nesicanucanu, ukuhlanza nokubona okufiphele.

Iziguli ezizwa i-migraine zizama, kaningi zingaphumeleli, izindlela ezahlukahlukene zokwelashwa, kufaka phakathi imishanguzo yokuthenga kanye nemithi ehlukahlukene kadokotela yokuvikela noma yokwelapha. Maphakathi noMeyi, i-FDA ivunyelwe umuthi wokujova wanyanga zonke ohloselwe ukuvimbela migraines .

Ochwepheshe bathola ukuthi ukunikezwa konyaka kwe Aimovig kuzobiza u- $ 6,900 kanti ngenkathi ithembisa ukukhululeka kweziguli ezimpawu eziphazamisa impilo yazo yansuku zonke, kuza ngemali ebiza cishe ama- $ 600 ngenyanga.