Ntau cov tshuaj siv los kho hypothyroidism tau rov qab los, raws li kev tshaj tawm ua ntej lub hlis no los ntawm Food and Drug Administration (FDA).
Westminster Pharmaceuticals LLC, lub tuam txhab uas tsim cov levothyroxine (LT4) thiab liothyronine (LT3) yeem rov qab cov tshuaj no.
Cov txheej txheem
hypothyroidism yog dab tsi?
Hypothyroidism, lossis cov thyroid tsis ua haujlwm, tshwm sim thaum cov thyroid caj pas tsis ua cov thyroid hormones txaus kom tau raws li koj lub cev xav tau. Cov thyroid caj pas nyob hauv koj lub caj dab. Cov tshuaj hormones uas nws tsim yog siv los tswj lub cev siv zog li cas.
Feem ntau yog mob me. Raws li National Institutes of Health, 4,6% ntawm cov neeg Asmeskas cov neeg muaj hnub nyoog 12 xyoos muaj hypothyroidism.
Qhov kev rov qab los tom qab Florida-based Westminster Pharmaceuticals siv cov khoom xyaw nrog qhov tsis zoo cuam tshuam nrog FDA Zoo Kev Ua Haujlwm Zoo.
Westminster Pharmaceuticals tau txais nws cov khoom xyaw nquag rau kev kho cov thyroid los ntawm Tuam Tshoj-based Sichuan Friendly Pharmaceutical Co. Limited - lub tuam txhab hais txog Ntshuam Ceeb Toom rau kev tsim khoom tsis zoo thaum lub sijhawm tshuaj xyuas FDA.
Thaum mus xyuas Sichuan Friendly cov chaw hauv xyoo 2017, cov neeg soj ntsuam tau tshawb pom cov mis tsis raug siv los suav cov potency ntawm cov khoom siv tshuaj.
Tsis tas li ntawd, ntau pawg ntawm cov tshuaj thyroid muaj cov ntawv pov thawj ntawm kev tshuaj xyuas uas muaj cov ntaub ntawv tsis raug thiab cov ntaub ntawv ruaj khov.
FDA ntseeg tias cov kev coj ua tsis zoo tuaj yeem ua rau muaj kev pheej hmoo vim muaj cov khoom xyaw tsis zoo. Cov tshuaj tsis sib haum tuaj yeem ua rau muaj kev pheej hmoo cuam tshuam nrog ntau dhau lossis tsis txaus hypothyroidism, FDA sau tseg tias "qhov no tuaj yeem ua rau muaj kev phom sij rau kev noj qab haus huv tas mus li."
Westminster Pharmaceuticals ntseeg tau tias tau yuav cov khoom xyaw ua ntej Sichuan tus phooj ywg ntshuam ceeb toom tau ua haujlwm zoo.
Cov neeg mob yuav ua li cas yog tias lawv siv cov tshuaj no?
Dr. Minisha Sood, kws kho mob endocrinologist ntawm Lenox Hill Tsev Kho Mob hauv New York tau hais tias "Kev rov qab tshuaj tuaj yeem ua rau muaj kev ntxhov siab, uas tuaj yeem nkag siab tau,"
Hauv tsab ntawv tshaj tawm los ntawm FDA, Westminster Pharmaceuticals pom zoo tias vim tias cov khoom no yuav raug siv los kho cov mob hnyav, "cov neeg mob noj cov tshuaj rov qab yuav tsum tau noj ntxiv mus txog thaum lawv muaj cov khoom hloov pauv".
Levothyroxine thiab liothyronine yog cov tshuaj tau muab los ntawm porcine (pig) cov thyroid caj pas. Lawv tsis cuam tshuam nrog kev phiv loj heev.
Westminster Pharmaceuticals tau rov qab los ntawm 15, 30, 60, 90 thiab 120 milligram versions ntawm levothyroxine thiab liothyronine hauv ntau. Lub Tuam Txhab ceeb toom nws cov nyiaj ncaj qha hauv xov tooj thiab email ncaj qha kom tsis txhob faib khoom.
Tsis tas li ntawd, lawv txhawb cov tuam txhab no kom nug lawv cov neeg muag khoom muag ua ib yam.
"Thaum peb sawv ntawm qhov zoo ntawm peb cov khoom, peb tab tom ua qhov kev ceev faj nruj tshaj plaws los ntawm kev rov qab los ntawm USP cov thyroid ntsiav tshuaj ntawm qib lag luam nkaus xwb, vim muaj kev tshuaj xyuas FDA tsis ntev los no ntawm ib qho ntawm peb cov tuam txhab ntawm cov khoom xyaw nquag," said tus tswv ntawm Westminster. Pharmaceuticals. thiab CEO Gajan Mahendiran txog lub tuam txhab lub vev xaib.
Txawm hais tias Westminster Pharmaceuticals tau rov qab cov tshuaj hauv ntau, cov kws kho mob thiab cov neeg mob raug txhawb kom tshaj tawm cov xwm txheej tsis zoo rau FDA's MedWatch Adverse Event Reporting Program.
Txog tam sim no, lub tuam txhab "tsis tau txais cov ntawv ceeb toom ntawm cov xwm txheej tsis zoo cuam tshuam txog cov khoom no," raws li lub tuam txhab FDA tshaj tawm.
Sood tau hais tias "Cov neeg mob yuav tsum tau lees paub tias tsis muaj qhov xwm txheej tsis zoo tau tshaj tawm txog tam sim no thiab qhov no yog kev yeem rov qab los," Sood hais. “Lawv yuav tsum tau noj lawv cov tshuaj ntxiv mus kom txog thaum lawv tuaj yeem tau txais cov tshuaj hloov tsim nyog los ntawm lawv tus kws kho mob lossis tus kws kho mob. »
Rajiv Bahl, MD, MBA, MS, yog tus kws kho mob xwm txheej ceev thiab kws sau ntawv kho mob. Koj tuaj yeem nrhiav tau ntawm www.RajivBahlMD.com.
