Ukuvunywa kwamva nje kwe-FDA kubandakanya iziyobisi kwi-opioid addiction, migraines, MS

Iindaba

Ukufumana imvume yamachiza kwi-FDA kubandakanya inkqubo elawulwa kakhulu efuna ukuba iinkampani zigqibe iimvavanyo zamanqanaba ngamanqanaba, zigcwalise izicelo ezahlukeneyo, kwaye ekugqibeleni zidlale umdlalo wokulinda ukufumanisa ukuba zingaya na phambili kwintengiso. Lilonke, kuthatha iminyaka eli-10 ukuba ichiza lifumane imvume ye-FDA, kwaye kutshanje indawo yentengiso ibone ukuvunywa okutsha okunikezela ngeziphumo ezithembisayo kwizigulana ezineemeko ezithile.

I-Lucemyra yonyango lweziyobisi opioid

Iingcali zonyango kudala zixhomekeka kumayeza athile ukunceda abaguli abanamakhoboka eziyobisi; Nangona kunjalo, la mayeza ngamanye amaxesha anokuzisa iseti yawo yeziphumo ebezingalindelekanga. Kwiimeko ezininzi, iiopioids zisetyenziswa njengenxalenye ye unyango oluncediswa ngamayeza , apho ichiza lidibanisa neendlela ezahlukeneyo zonyango ukunceda abantu ukuba baphule ukuxhomekeka kwabo.

Nangona kunjalo, ukusetyenziswa gwenxa kwe-opioid kunye nokusetyenziswa gwenxa kuxhaphakile kwilizwe liphela. Ngo-2016 kuphela, Kusweleke abantu abayi-116 Yonke imihla njengesiphumo sokudlula ngaphezulu kweopioid. Kumzamo wokunceda kulo bhubhane, i I-FDA inike imvume ye-lofexidine.

Ithengisiwe njenge Lucemyra , I-lofexidine sisiyobisi esenzelwe ukubuyisela i-opioids kunye nokuxhomekeka okuza nazo njengoko abaguli behamba ngokurhoxa. Esinye sezibonelelo eziphambili zeli chiza kukuba lenziwe ngendlela yokuba abantu bangabinakho ukuba likhoboka lalo, kwaye libonakalise ithemba elikhulu kuseto lolingo lwezonyango.

I-Gilenya yonyango lwe-sclerosis

Olunye uhambelwano kwimarike yamayeza iza ne I-FDA ukwandiswa kwemvume Gilenya , iyeza elavunywa okokuqala ngo-2010 ukunyanga abantu abadala ngokubuyela kwakhona kwi-multiple sclerosis. Ulwandiso luvumela ukuba lusetyenziselwe ukunyanga abaguli abaneminyaka eli-10 nangaphezulu abanengxaki yokuphindaphindeka kwesifo sokuqina kwemithambo. Nangona uninzi lwabantu lufunyaniswa lune-MS phakathi kweminyaka engama-20 ukuya kwengama-50, abantwana abanengxaki kule meko bahlala befumana umgangatho wobomi owehle kakhulu.

I-Multiple sclerosis ibonakaliswa ziimpawu ezininzi (njengentlungu, ukungcangcazela, ukuba nesiyezi, ukuhamba nzima, phakathi kwabanye) okuphumayo nokuhamba. Njengesifo esingapheliyo sokuzimela, siphazamisa iinkqubo zonxibelelwano phakathi kwengqondo yakho nomzimba wakho.

I-Aimovig yonyango lwe-migraine

Abantu abangaphezu kwezigidi ezingama-38 bachaphazeleka yimigraines eU.S. Ukongeza kwintlungu entloko, abantu abafumana imigraines bahlala befumanisa ukuba banovakalelo olumangalisayo kwisandi kunye nokukhanya, kwaye banokude babe nesicaphucaphu, ukugabha nokungaboni kakuhle.

Izigulana ezifumana i-migraine zizama, zihlala zingaphumeleli, kunyango olwahlukeneyo, kubandakanya amayeza e-counter kunye namayeza ahlukeneyo amiselweyo othintelo okanye unyango. Phakathi ku-Meyi, I-FDA yamkelwe iyeza lonyaka elitofwayo elijolise ekuthinteleni migraines .

Iingcali zifumanisa ukuba unikezelo lonyaka lwe UAimovig iya kuxabisa i-6,900 yeedola kwaye ngelixa ithembisa abaguli ukukhululeka kwiimpawu eziphazamisa ubomi babo bemihla ngemihla, iza ngendleko ephantse ibe yi- $ 600 ngenyanga.