Levothyroxine izidakamizwa ezifana Synthroid Kwadingeka Ukubonisa Ukuzinza, Ukuvumelana
Ngo-September ka-1997, isimemezelo sagudluza umphakathi wesiguli wegciwane. Ngokuyinhloko, kuthintela lezo ziguli ezithatha esinye sezidakamizwa ezithathelisayo ze- hormone ezifana ne-Synthroid, Levoxyl, nezinye-ngokusekelwe kwe-levothyroxine sodium.
Ngokwesimemezelo se-Federal Register ngaleso sikhathi,
... akukho okhiqizwa ngomkhiqizo we-levothyroxine sodium okwamanje okhiqiwe ngomlomo okwenziwe ngomlomo ukuthi ubonise ukuqina okunamandla nokuzinza futhi, ngakho-ke, akukho mkhiqizo we-levothyroxine sodium okwamanje odayiswa ngomlomo ngokuvamile kubonakala sengathi uphephile futhi usebenza kahle.
Ngaleso sikhathi, uhulumeni wayethole ukuthi izidakamizwa ze-levothyroxine ngokuvamile azizange zihlale zikhona ngezikhathi zabo zokuphelelwa yisikhathi, futhi amaphilisi amandla afanayo okulinganisa avela kumkhiqizi ofanayo atholakale ehluke ekusebenziseni i- lot to lot, ngokwemali yokusebenza isithako samanje. Lokhu ukungabi nokuzinza nokuqina okunamandla kwakungabangela imiphumela engathà sina yempilo kulabo abathatha le mithi.
I-Levothyroxine sodium yaqala ukungena emakethe ngaphambi kuka-1962, ngaphandle kwe-"Isicelo Esisha Sokudakwa Kwezidakamizwa" (i-NDA) esamukelekile, ngokusobala ekukholweni ukuthi akusiyo isidakamizwa esisha.
Kusukela ngaleso sikhathi, cishe wonke umkhiqizi wemikhiqizo ye-levothyroxine ye-sodium, ehlanganisa i-Synthroid, wayebike njalo ukuthi kwakuyiziphumo zezinkinga ze-potency noma zokuzinza.
Kwezinye izimo, izinkinga zibangelwa ukuthi i- levothyroxine sodium ayizinzile lapho kukhona ukukhanya, izinga lokushisa, umoya nomswakama.
Esikhathini esiphakathi kuka-1991 no-1997, kwakungenakukhumbula okungaphansi kwezingu-10 zeethevothyroxine amaphilisi e-sodium afaka amaphesenti angu-150 namaphilisi angaphezu kwezigidi ezingu-100. Kuzo zonke izimo, kodwa okukhunjulwayo kuqaliswe ngoba amaphilisi atholakale engekho noma ngenxa yokuthi amaphilisi awo e-levothyroxine alahlekelwa isikhathi ngaphambi kokuphela kwesikhathi.
Okukhunjulwa okusele kwaqaliswa umkhiqizo owatholakala ukuthi unamandla kakhulu. Phakathi nalesi sikhathi, i-FDA iphinde ikhishwe izixwayiso kumkhiqizi mayelana nomkhiqizo we- levothyroxine sodium owalahlekelwa amandla lapho ugcinwa ekugcineni okuphezulu kwezinga lokushisa elinconywayo, kanti lowo obani obunamaphesenti angu-74.7 kuya ku-90.4, esikhundleni samaphesenti angu-90 kuya ku-110 amaphesenti adingeka ngaleso sikhathi.
Izinkinga nazo zibangelwa izinguquko zokwakha. Ngenxa yokuthi le mikhiqizo yayithengiswa ngaphandle kwama-NDA, abakhiqizi bekungadingeki bafake isicelo sokugunyazwa kwe-FDA njalo lapho beguqulela imikhiqizo yabo ye-levothyroxine. Abakhiqizi base beguqule izithako ezingasebenzi, uhlobo lomzimba lwamabalabala kanye nezinye izici zomkhiqizo, okwenza izinguquko eziphawulekayo ku-potency, kwezinye izimo zanda noma zinciphisa amandla ngamaphesenti angama-30. Ngenxa yalokho, kwezinye izimo, abantu abanesilinganiso esifanayo seminyaka baba yingozi futhi bagxila ngokweqile - noma bangaphansi - ngesilinganiso esifanayo. Kwakukhona ubufakazi bokuthi abakhiqizi baqhubeka nokwenza lezi zinguquko zokuguqula ezithinta amandla.
Ngemva kwalokho, eminyakeni engama-35 emva kokusungulwa kwawo, i-US Food and Drug Administration (FDA) yase-United States yakhipha isaziso (i- Federal Register , ngo-Agasti 14, 1997) ukuthi imikhiqizo yezidakamizwa ezilawulwa ngomlomo equkethe i-levothyroxine sodium yabizwa ngokusemthethweni ngokuthi "imithi emisha" futhi idinga ukuhamba inqubo ye-NDA ngenxa yenkinga yokuzinza nokuqina okwakubonakala.
Ukuze uqhubeke nokukhangisa lezi zidakamizwa, abakhiqizi badinga ukuhambisa i-NDA ngobufakazi obubhalwe phansi bokuthi umkhiqizo wenkampani ngayinye uphephile, usebenza kahle futhi wenziwe ngendlela yokuqinisekisa ubungako obuqinile. Ngenxa yokuthi izidakamizwa ziyadingeka ezigidini zaseMelika, i-FDA ivumele abakhiqizi ukuba baqhubeke bethengisa le mikhiqizo ngaphandle kwe-NDA evunyiwe kuze ku-Agasti 14, 2000, ukuze banikeze izinkampani isikhathi esanele sokuqhuba izifundo ezihlukahlukene zocwaningo nokuhambisa ama-NDA abo.
Imiphumela yeziguli
Ngabe lezi zintuthuko zenzani iziguli ezithatha imikhiqizo ye-levothyroxine ye-hormone esikhundleni sakho?
- Ngisho nalapho udokotela ebeka njalo uhlobo olufanayo lwe-levothyroxine sodium olulawulwa ngomlomo, ngokugcwaliswa kwemithi ngayinye, iziguli zagijima i-RISK yokuthola umkhiqizo ohlukile ekutheni umthamo onikeziwe.
- Uma ngabe izidakamizwa zitholakale zingenamandla kakhulu, iziguli zaba yi-HYPOTHYROID nezimpawu ezinzima ezifana nokucindezeleka okukhulu, ukukhathala, ukutholakala kwesisindo, ukuqothulwa, ukubekezeleleka okubandayo, ukuvuvukala, nobunzima ukugxila.
- Uma ngabe izidakamizwa zitholakele kakhulu, iziguli zingathola izimpawu ezinzima ze-HYPERTHYROIDISM njengezinhlungu zenhliziyo, izinhliziyo zenhliziyo, noma ama-arrhythmias enhliziyo. Kulezi ziguli ezinesifo senhliziyo, ngisho nokwanda okuncane emthamo we-levothyroxine sodium kungaba yingozi. Futhi ucwaningo lubonisa ukuthi ukweqisa kancane kwe-levothyroxine sodium njengalokho okungase kubangelwe ukwanda kwe-potency kungakhuphula ingozi ye-osteoporosis ngokubangela i-hyperthyroidism engaphansi kwe-subclinical.
- Ukuhlukahluka kwe-potency kungenza ukulingana okungenakwenzeka kungenakwenzeka. I-Levothyroxine amaphilisi e-sodium afika emandleni amancane afana nemali encane kakhulu, evumela udokotela wakho ukuba athole kahle imithi efanele. Kodwa uma inani lemithi esebenzayo elitholakalayo elinganisweni ethile lihluka, lokhu kwenza ukuthola nokulondoloza umthamo ofanele wena ngisho nobunzima obuningi.
QAPHELA: Abakhiqizi bezidakamizwa bagcina befake i-NDAs ye-levothyroxine, futhi i-levothyroxine, ngo-2017, isidakamizwa esivunyelwe yi-FDA.