Isexwayiso sebhokisi elimnyama yisixwayiso esiqine kakhulu esikhishwe yi-US Food and Drug Administration (FDA) ukuthi imithi ingathatha futhi isale emakethe e-United States.
Isixwayiso sebhokisi elimnyama livela ebulaweni lwemithi kadokotela ukuze sikuxwayise nomhlinzeki wakho wezempilo mayelana nanoma yikuphi ukukhathazeka okubalulekile, njengemiphumela emibi kakhulu noma izingozi ezisongela ukuphila.
Isixwayiso sebhokisi elimnyama, eyaziwa nangokuthi "isixwayiso selebula omnyama" noma "isixwayiso esiphezulu," sabizwa ngokuthi umngcele omnyama ozungezile umbhalo wesilumiso esivela kufakwe iphakethe, ilebula, nezinye izincwadi ezichaza imithi (isibonelo , ukukhangisa umagazini).
Lapho i-FDA idinga eyodwa
I-FDA idinga isixwayiso sebhokisi elimnyama kwesinye sezimo ezilandelayo:
- Imithi ingabangela imiphumela engathandeki embi (njengokubulala, kokusongela impilo noma ukuvimbela unomphela ukusabela okubi) uma kuqhathaniswa nokuhlomula okungenzeka okuvela kulo muthi. Ngokuya ngesimo sakho sezempilo, wena nodokotela wakho kuzodingeka unqume ukuthi ingabe inzuzo engaba khona yokuthatha lesi sidakamizwa iwufanele ingozi.
- Ukusabela okungathí sina okunzima kungavinjelwa, kuncishiswe ngezikhathi ezithile, noma kuncishiswe ngobukhulu ngokusetshenziswa kahle kwezidakamizwa. Isibonelo, imithi ingase iphephile ukusebenzisa kubantu abadala, kodwa hhayi ezinganeni. Noma-ke, lesi sidakamizwa singasilondekile ukusebenzisa abesilisa abadala abakhulelwe.
Ulwazi oludingekayo
I-FDA idinga isixwayiso esikhwameni sokunikeza isishwankathelo esifushane semiphumela emibi nezingozi ezihlobene nokuthatha imithi. Wena nodokotela wakho kudingeka uqaphele lolu lwazi uma unquma ukuqala umuthi noma uma kufanele ushintshe kwenye imithi ngokuphelele.
Ukuqonda imiphumela emibi kuyokusiza ukuthi wenze isinqumo esingcono.
Izibonelo zokuxwayisa
Okulandelayo yizibonelo zexwayiso zamabhokisi amnyama ezidingekayo eminye imithi esetshenziswa kakhulu:
Ama-antibiotics e-Fluoroquinolone
Ngokusho kwe-FDA, abantu abathwala imithi ye-fluoroquinolone banomngcipheko owengeziwe we-tendinitis nokuhlukana kwetendon, ukulimala okunzima okungabangela ukukhubazeka okungapheli. Isixwayiso se-FDA sihlanganisa i-Cipro (ciprofloxacin), iLevaquin (levofloxacin), i-Avelox (moxifloxacin) neminye imithi equkethe i-fluoroquinolone. (Isixwayiso esikhishwe ngoJulayi 2008.)
Imithi yesifo sikashukela
Ngokusho kwe-FDA, abantu abanesifo sikashukela bathatha i- Avandia (rosiglitazone) banengozi eyengeziwe yokwehluleka kwenhliziyo noma ukuhlasela kwenhliziyo uma benesifo senhliziyo noma basengozini enkulu yokuhlushwa isifo senhliziyo. (Isixwayiso esikhishwe ngoNovemba 2007.)
Imithi yokucindezeleka
Ngokusho kwe-FDA, yonke imishanguzo yokucindezeleka isengozini enkulu yokuzibulala nokuziphatha okuzibulala, eyaziwa ngokuthi ukuzibulala, kubantu abadala abaseneminyaka engu-18 kuya ku-24 ngesikhathi sokwelashwa kokuqala (ngokuvamile okokuqala kuya ezinyangeni ezimbili). Isixwayiso se-FDA sihlanganisa i-Zoloft (sertraline), i-Paxil (i-paroxetine), i- Lexapro (escitalopram), nezinye izidakamizwa zokucindezeleka.
(Isixwayiso esikhishwe ngoMeyi 2007.)
Yini Obukeka Ngayo?
Ingqikithi elandelayo evela ebhalweni lokubhala le-Zoloft yisibonelo somxwayiso webhokisi elimnyama.
Ukuzibulala ku-Children and Adolescents
Ama-anti-depressants akhulisa ingozi yokuzibulala nokuzibulala (ukuzibulala) ngezifundo zesikhathi esifushane ezinganeni nasebancane abane-Major Depressive Disorder (MDD) nezinye izifo ezingokwemvelo. Noma ubani ocabangela ukusetshenziswa kukaZoloft noma yimuphi omunye odokotela ocindezelekayo emntwaneni noma osemusha kumele alinganise le ngozi ngezidingo zomtholampilo. Iziguli eziqaliswa ekwelapheni kufanele zibhekwe ngokucophelela ekukhusheni komzimba, ukuzibulala, noma izinguquko ezingavamile kokuziphatha. Imindeni kanye nabanakekeli kumele baziswe ngesidingo sokubheka okusheshayo nokuxhumana nomthetho. I-Zoloft ayivunyelwe ukusetshenziswa kweziguli zezingane ngaphandle kweziguli ezine- dispersive-compulsive disorder (OCD).
Imithi yama-opioid
Ngo-2013, i-FDA ikhiphe isitatimende esichaza ukubhekwa kokuphepha kokufunda ekilasini kuwo wonke ama-analgesics e-opioid okukhululwa okulethwa isikhathi eside (ER / LA). Ingxenye eyodwa yalezi zinguquko ihilela izixwayiso ezihlosiwe ezibonisa ubungozi bokusebenzisa kabi i-opioid, ukuhlukunyezwa, ukuthembela. ukudlula ngokweqile kanye nokufa ngisho nasezintweni eziphakanyisiwe.
Ngonyaka we-2016, i-FDA yakhipha isiqondiso esifanayo sokulayishwa kwelebula kanye nezixwayiso zemithi e-opioid yokukhululwa ngokushesha.
Kuhlangene, izinguquko zisempendulo ngokuqondile esiwumshayabhuqe we-opioid esithinta i-United States. Ngaphezu kwalokho, i-FDA ifuna ukugcizelela ukuthi imithi yama-opioid kufanele isetshenziswe kuphela ezimweni zobuhlungu obunzima obungaphathwa ngenye indlela. Ngamanye amazwi, i-opioid iyimithi eyingozi uma ingasetshenziswanga ngokuhlakanipha ngaphansi kokuqondiswa kukadokotela.
Ukuqondiswa kwemithi
Kanye nexwayiso lebhokisi elimnyama, i-FDA idinga nokuthi inkampani yezidakamizwa idale umhlahlandlela wemithi equkethe ulwazi kubathengi ngendlela yokusebenzisa imithi ethile ngokuphepha. Iziqondiso ziqukethe ulwazi oluvunyelwe yi-FDA olungakusiza ukuba ugweme isenzakalo esibi esibi.
Lezi ziqondiso zihloswe ukuba zinikezwe yikhemikhali yakho ngesikhathi usugcwalisile imithi yakho. Imikhombandlela iyatholakala kuyi-intanethi kusuka kwenkampani yezidakamizwa nakwi-FDA. Isibonelo, umhlahlandlela wezokwelapha u-Avandia (rosiglitazone) utholakala ku-GlaxoSmithKline, umkhiqizi wase-Avandia, naku-FDA Isikhungo sokuHlola nokuHlola kweDrug.
Uma ukhathazekile ukuthi imithi yakho inexwayiso ebhokisini elimnyama, cela umuthi wakho wemithi futhi uma ikhona, thola ikhophi ephrintiwe yomhlahlandlela wemithi.
Izinsiza ezengeziwe
Isikhungo Sokwaziswa Kwezidakamizwa se-Kansas University Medical Centre sigcina uhlu lwe-intanethi yazo zonke izidakamizwa ezinesixwayiso sebhokisi elimnyama. Imithi ibhalwe ngamagama ajwayelekile. Uma uthatha isidakamizwa segama lomkhiqizo , kuwukuhlakanipha ukubuka igama lesizukulwane .
> Imithombo
> I-FDA News Release. U-FDA umemezela izixwayiso ezithuthukisiwe zemithi yokuhlunguphazwa kwama-opioid ngokushesha ehlobene nezingozi zokusebenzisa kabi kabi, ukuhlukunyezwa, ukubheja ngokweqile, ukudlula ngokweqile nokufa.
> I-FDA News Release. I-FDA imemezela ukuguqulwa kokubhalisa kokuphepha kanye nezidingo zokutadisha i-postmarket zokuhlaziya okudelelwe futhi okudala isikhathi eside se-opioid analgesics.