Ukuba uphanda i-levothyroxine kunye nezidakamizwa ze-liothyronine ukunyanga i-hypothyroidism, unokuva malunga nophando lwe-US Food and Drug (FDA) ku-Mylan. U-Mylan ngumenzi wesithathu wezilwanyana ezikhulu kakhulu emhlabeni, kunye nomvelisi we-levothyroxine kunye ne-liothyronine, i- generic version yeCrotomel . Zomibini izidakamizwa i-thyroid i-hormone i-substitution medication esetyenziselwa ukuxazulula i-hypothyroidism.
Ehlotyeni ka-2009, i-FDA yavula uphando, kodwa kwiiveki ezimbalwa, uphando lwavalwa, kwaye akukho bungqina bokuba umgangatho wezilwanyana ezenziwe nge-Mylan, kuquka ne-levothyroxine, zachaphazeleka.
Nanku ulwazi olufunekayo ukuze ukwazi ukuba wenze isigqibo esinolwazi malunga nala mayeza.
Imvelaphi
Ngo-2009, i-West-based yaseVirginia eyayiseMylan yayingumxholo wophando olusemthethweni kwiingxaki zemveliso kwisityalo sabo. IGazethi yePottburgh Post yaqhekeza ibali labasebenzi kwi-plant yaseMylan yaseWest Virginia, ababekho, ngokwemiqulu yangaphakathi efunyenwe yi- Post-Gazette , "rhoqo ngokugqithiseleyo izixwayiso zekhompyutheni malunga neengxaki ezinokuthi zivelise."
Ngelo xesha, i-FDA yathi i-Mylan ibandakanyeka ekukhohliseni ulwazi kunye nokutshintshwa kwemveliso, mhlawumbi iminyaka emibini okanye ngaphezulu. Emva kokuba i-FDA ivule uphando eMylan, inkampani inikezele ingxelo ebonisa ukuba uphenyo lwe-FDA luqhelekileyo.
Kodwa-ke, i-FDA, ithathe isinyathelo esingavamile sokukhupha isitatimende ukuphikisa nokuphinda senze imizamo kaMylan yokunciphisa ubunzima bophando.
Ngethuba lophando lwasungulwa, i- Pittsburgh Post-Gazette yanikezela ngokukhawuleza kwenkcazo yemeko yaseMylan, kubandakanywa namanqaku alandelayo:
- Abasebenzi baseMylan banqabile ukulawulwa komgangatho weziyobisi, ingxelo yengxelo ephakathi 'ephazamisayo' yokungahoywa iinkqubo zokukhusela - Julayi 26, 2009
- Umhlahlandlela we-Mylan 'obomvu' - uJulayi 26, 2009
- I-FDA ihlola izenzo ze-Mylan, ukuphulwa komgangatho wokuziphatha kuthethwe kwingxelo yangaphakathi-Julayi 28, 2009
- "I-FDA igxeka ingxelo ye-Mylan" -Julayi 28, 2009
Emva kweeveki ezimbalwa apho amaxabiso e-Mylan amasheya awela, kwaye i-Mylan ne-FDA yaqhuba imfazwe yamazwi kumaphephandaba. U-Mylan uphinde waxoxela abalandeli be- Gazette Post Gazette abaphulaphula ibali ngokuchaswa.
I-FDA ekugqibeleni yahlutha i-Mylan, yenza isaziso ngomhla ka-Agasti 13, 2009. Ngokutsho kwe-FDA, i-Mylan ibenze uphando olwaneleyo, isithethi se-agency, kunye ne-FDA ivaliwe uphando.
I-Mylan ityala malunga nephephandaba lahlaliswa ngo-2012, kwaye i-Mylan kunye ne- Post-Gazette bakhulisa isitatimende esathi, ngenxalenye:
Ulwaphulo-mthetho luye lwasombululwa ukwenzela ukwaneliseka kwamaqela amabini. I-Post-Gazette ayifumananga kwaye ayizange ihlose ukubika ukuba i-Mylan yenze okanye isasaze iiphina iziyobisi.
ILizwi
Ingqwalaselo yale meko kwizigulane ze-thyroid kwakukho ubungqina bokuthi umgangatho wezilwanyana ezenziwe yi-Mylan, kubandakanya i-levothyroxine kunye neziyobisi ze-liothyronine ezithathwe ngabantu abaninzi abane-hypothyroidism, zachaphazeleka ngandlela-thile.
Ngexesha elifanayo, abantu abane-hypothyroidism bathatha i-thyroid ye-hormone esikhundleni sonyango i-levothyroxine kufuneka baqaphele ukuba oogqirha abaninzi abacebisi ukuba izigulane ze-thyroid zithathe nayiphi na i-levothyroxine ephuma kunoma yimuphi umenzi. Isizathu kukuba zonke izidakamizwa ze-levothyroxine, kubandakanywa nezidakamizwa zamagama kunye ne-brand name, zivunyelwe ngokusemthethweni ukuba zihluke kwi-potency ukusuka kuma-95 ukuya kuma-105 ekhulwini we-dosage echazwe. Xa uthatha i-levothyroxine, i-refill ivela kumntu nawuphi na umenzi, oko kuthetha ukuba ukuzaliswa nganye kweringo echaziweyo kungawela naphi na kuloo ndawo.
Nangona ukutshintshana okuncane kumbindi kungaphazamisa ukusebenza kwe-thyroid hormone esikhundleni.
Ukunyuswa kwe-hormone ye-thyroid kubaluleke kakhulu kubasindile bomdlavuza we-thyroid, abangathi bafune ukuba amazinga e-hormone (TSH) aphethwe ngokunyanisekileyo njengengxenye yonyango lwabo, kunye nokuthintela ukuphindaphinda umdlavuza we-thyroid.
Ukuba uthatha i-levothyroxine yendalo kunoma yimuphi umenzi, kuyincedo ukuxoxa ngeemeko ezithile kunye nomboneleli wakho wezempilo, ukugqiba ukuba ngaba igama lonyango lobizo luza kuba yindlela engcono kunyango lwakho.