Uma ucwaninga i-levothyroxine ne-liothyronine izidakamizwa zokwelapha i-hypothyroidism yakho, ungase uzwe mayelana nophenyo lwe-US Food and Drug Administration (FDA) ku-Mylan. U-Mylan ungumenzi wesithathu wezidakamizwa ezikhiqiza izidakamizwa, futhi umkhiqizi we-generic levothyroxine ne-liothyronine, uhlobo oluvamile lwe-Cytomel yezidakamizwa . Zombili izidakamizwa kukhona imishanguzo ye-hormone esikhundleni sokuguqula imithi esetshenziselwa ukuxazulula i-hypothyroidism.
Ehlobo lika-2009, i-FDA yavula uphenyo, kodwa kungakapheli amasonto ambalwa, uphenyo luvaliwe, futhi abukho ubufakazi bokuthi izinga lemithi eyenziwa yi-Mylan eyenziwe, kuhlanganise ne-levothyroxine, lathintekile.
Nansi ulwazi oludinga ukwazi ukwenza isinqumo esinolwazi mayelana nale mithi.
Ingemuva
Ngonyaka ka-2009, i-Mylan yaseWest Virginia eyayise-West Virginia yayihlolisisa izinkinga zokukhiqiza ezitshalweni zabo. Iphephandaba lasePittsburgh Post lihlehlise indaba yabasebenzi e-Mylan's West Virginia plant, okwakuyizincwadi zangaphakathi ezitholwe yi- Post-Gazette , "ngokuphindaphindiwe kunamaxwayiso akhiqizwa ngekhompiyutha mayelana nezinkinga ezingase zibe nemithi ababeyikhiqiza."
Ngaleso sikhathi, i-FDA ithe uMylan wayebandakanyekile ekukhohliseni ulwazi nokushintsha imikhiqizo, mhlawumbe isikhathi eside seminyaka emibili noma ngaphezulu. Ngemuva kokuthi i-FDA ivule uphenyo eMylan, inkampani yakhipha isitatimende esikisela ukuthi uphenyo lwe-FDA luyisimiso.
I-FDA, Nokho, yathatha isinyathelo esingavamile sokukhipha isitatimende ukuphikisana nokuphinda senze imizamo kaMylan yokunciphisa ubukhulu bophenyo.
Ngesikhathi uphenyo lwasungulwa, i- Pittsburgh Post-Gazette yanikezela ngokujulile isimo se-Mylan, kuhlanganise nezihloko ezilandelayo:
- Abasebenzi baseMylan banqothule ukulawulwa kwekhwalithi yezidakamizwa, umbiko wangaphakathi owenziwe ngokugcwele 'wokuphazamiseka' wokungazinaki izinqubo zokuphepha - July 26, 2009
- Umgqa wesikhathi sesikhathi sikaMylan's 'screen red' - July 26, 2009
- I-FDA ihlola izenzo zikaMylan, ukuhlukunyezwa kwekhwalithi kukhishwe umbiko wangaphakathi - uJulayi 28, 2009
- "I-FDA iphikisa isitatimende seMylan" - July 28, 2009
Ngemuva kwamasonto ambalwa lapho amanani esitokisi ka-Mylan awela khona, futhi i-Mylan ne-FDA baqhuba impi yomphakathi emaphephandabeni. U-Mylan uphinde wamangalela abezindaba bePitetburgh Post Gazette abaqedile indaba yokuhlambalaza.
I-FDA ekugcineni yahlanza i-Mylan, yenza isimemezelo ngo-Agasti 13, 2009. Ngokusho kwe-FDA, i-Mylan yayenze uphenyo olwanele, okhulumela i-agency, ne-FDA bavala uphenyo.
I-Mylan iphikisana nephephandaba ihlelwe ngo-2012, kanti i-Mylan ne- Post-Gazette bakhipha isitatimende esithi, ngokwengxenye:
Ukuthethwa kwecala kuye kwaxazululwa ukwanelisa bobabili abathintekayo. I-Post-Gazette ayitholanga futhi ayihlose ukubika ukuthi i-Mylan yayikhiqize noma yasakaza noma yiziphi izidakamizwa ezingalungile.
Izwi kusuka
Ukuphikisana kwalesi simo iziguli ze-thyroid kwakuwukuthi kwakungekho ubufakazi bokuthi izinga lemithi eyenziwa yi-Mylan, kuhlanganise ne-levothyroxine ne-liothyronine izidakamizwa ezithathwe abantu abaningi abane-hypothyroidism, zathinteka nganoma iyiphi indlela.
Ngesikhathi esifanayo, abantu abane-hypothyroidism bathatha i-hormone ye-hormone esikhundleni se-drug levothyroxine kudingeka baqaphele ukuthi odokotela abaningi AKUKHUTHI ukuthi iziguli ze -roid zithatha noma yikuphi i-levothyroxine ejwayelekile kusuka kunoma yimuphi umkhiqizi. Isizathu siwukuthi zonke izidakamizwa ze-levothyroxine, kuhlanganise nezidakamizwa zamagama ezijwayelekile kanye negama, zivunyelwe ngokomthetho ukuba ziguquke ekutheni zivela kumaphesenti angama-95 kuya ku-105 eminganisweni ebekiwe. Uma uthatha i-levothyroxine ejwayelekile, i-refill ingavela kunoma yimuphi umkhiqizi, okusho ukuthi ukugcwaliswa ngalunye komthamo owethiwe kungawela noma yikuphi ngaphakathi kwaleso sigaba se-potency.
Ngisho nokuhluka okuncane ku-potency kungaphazamisa ukusebenza kwe-thyroid hormone esikhundleni sakho.
Ukuqiniswa kwesimo se-hormone ye-thyroid futhi kubaluleke kakhulu kubasindile bomdlavuza we-thyroid, abangase badinge amazinga we-hormone (TSH) we-thyroid avuselelwe njalo njengengxenye yokwelashwa kwawo, nokuvimbela ukuphindaphinda komdlavuza we-thyroid.
Uma uthatha i-levothyroxine ejwayelekile kunoma yimuphi umkhiqizi, kuyasiza ukuxoxa ngesimo sakho esithile nomhlinzeki wakho wezempilo, ukucacisa ukuthi ngabe igama lomuthi wegama lomkhiqizo liyoba yini engcono ukwelashwa kwakho.