Levothyroxine Zvinodhaka SeSythroid Zvakafanirwa Kuratidza Kudzoka, Kubatana
MunaSeptember muna 1997, chiziviso chakazunungusa chikwata chevarwere chetachiona. Kunyanya, yakabata varwere avo vakanga vari kutora imwe yehutori inoshandiswa zvinodhaka zvinoshandiswa-seSyroid, Levoxyl, nevamwe-zvichibva muLevothyroxine sodium.
Maererano neDare reGwaro Rekuzivisa panguva iyoyo,
... kwete ikozvino inotengeswa nemuromo inonzi levothyroxine sodium yakagadzirwa kuratidzira kuratidzira kuratidzira nekugadzikana uye, nekudaro, hapana ikozvino inotengeswa nemuromo inogadziriswa levothyroxine sodium chinhu inowanzoonekwa seine ngozi uye inoshanda.
Panguva iyoyo, hurumende yakanga yawana kuti levothyroxine sodium madawa kakawanda haina kuramba yakasimba kuburikidza nekupera kwemazuva ayo, uye mahwendefa emasimba akaenzana emurairo kubva kumugadziri mumwechete akawanikwa akasiyana mukuita kubva mujenya kusvika mujenya maererano nehuwandu hwekushanda zvigadzirwa zviripo. Kushayikwa kwekudzikama uye kusagadzikana kwemaitiro kwakakwanisa kukonzera migumisiro yakakomba yeutano kune avo vanotora mishonga iyi.
Levothyroxine sodium yakatanga kuiswa mumusika isati yasvika muna 1962, isina kubvumidzwa "New Drug Application" (NDA), zvichida mukutenda kuti yakanga isiri mushonga mutsva.
Kubvira panguva iyo, inenge imwe neimwe yakagadzirwa nemagetsi eivhiyovineroxine sodium products, kusanganisira Synthroid, yakanga yagara ichitaura kuyeuka iyo yaiva yakaguma nematambudziko kana kuti kugadzikana.
Mune zvimwe zviitiko, zvinetso zvinokonzerwa nekuti levothyroxine sodium haina kugadzikana pamberi pechiedza, kutonhorera, mhepo, uye humhutu.
Pakave pakati pe1991 na1997, pakanga pasina zvinyorwa zvisingasviki gumi zvepavothyroxine mahwendefa e-sodium anosanganisira 150 majenya nemapiritsi ane mamiriyoni zana. Muzvikamu zvose kunze kwechimwe chete, zviyeuchidzo zvakatangwa nokuti mahwendefa akawanika kunge asina kunyanya kukosha kana kuti mapiritsi awo e levothyroxine akarasikirwa nehupenyu vasati vapera mazuva.
Zviyeuchidzo zvakasara zvakatangwa nokuda kwechigadzirwa chakanga chikaonekwa kuti chakanyanyisa. Munguva iyi, FDA yakapawo nyevero kumudziri wekodzero yeevidroroxine sodium yakarasikirwa ne potency iyo yakachengetedzwa pamucheto wakakwirira wehutano hwakarongedzwa, uye uyo ane simba kubva 74.7 muzana kusvika 90.4, panzvimbo ye 90 kusvika ku10 peresenti inoda panguva iyoyo.
Zvinetso zvakare zvakakonzerwa nekugadzirisa kushanduka. Nemhaka yokuti zvigadzirwa izvi zvakanga zviri kutengeswa pasina NDA, vakugadziri vanga vasina kutora kuti FDA igamuchirwe nguva imwe neimwe pavakachinja maitiro avo e levothyroxine sodium. Vagadziri vakanga vashandura zvisingashandisi zvishandiso, maitiro evanhu vemavarai uye mamwe maitiro emuchina, zvichiita kuti kuve nekushandurwa kwakakura mumhepo, pane dzimwe nguva kuwedzera kana kuderera kwemaitiro zvinodarika 30 muzana. Somugumisiro, pane dzimwe nguva, vanhu vaiva nemutengo wakafanana wemakore vakava nehutu uye vakafukidzwa-kana kuti vakaiswa pasi-pamutengo mumwe chete. Ikoko kwakanga kune uchapupu hwekuti vaiti vekugadzira vakaramba vachiita zvinhu izvi zvekushandura kwakagadzirisa zvinoshandisa simba.
Zvadaro, makore makumi matatu mushure mekutsvaga kwavo, US Food and Drug Administration (FDA) yakabudisa chiziviso ( Federal Register , Gumiguru 14, 1997) iyo miviri yakashandiswa pamigumisira ine levothyroxine sodium yakarongedzwa se "mishonga mitsva" uye yaifanira kupfuura chirongwa cheNADA nekuda kwekudzikama uye zvinetso zvehutu zvakanga zvava pachena.
Kuti varambe vachitsvaga madhiragi aya, vashandi vanodikanwa kutumira NDA nehumwe uchapupu hwakanyorwa kuti mushandi wekambani imwe neimwe yakachengeteka, inobudirira, uye inogadzirwa nenzira inoita kuti hurumende ishande. Nemhaka yokuti mishonga inodiwa kune mamiriyoni eAmerica, FDA yakabvumira vashandi kuti varambe vachida kutengesa mishonga iyi kunze kweAIDS yakagamuchirwa kusvikira August 14, 2000, kuitira kupa makambani nguva yakakwana yekuitisa zvidzidzo zvakasiyana-siyana zvekutsvaga uye kuendesa maNAA avo.
Migumisiro yevarwere
Ndezvipi zvinogadziriswa izvi izvi kune varwere vachitora levothyroxine thyroid hormone replacement products?
- Kunyangwe apo chiremba aigara achitsanangura mararamiro mamwechete emiromo inogadziriswa levothyroxine sodium, uye chirevo chega chega chekugadzirisa, varwere vakashanda RISK yekugamuchira chigadzirwa chinowanika mukugadzirisa kubva pamuti wakapa.
- Kana mushonga wacho wakagamuchira waiva muduku kudarika, varwere vakava HYPOTHYROID uye vakatambura zviratidzo zvakadai sokuora mwoyo zvakanyanya, kuneta, kuwedzera kuwanda, kuvhiringidzika, kusagadzikana kwechando, kuzvimba, uye kuoma kuisa pfungwa.
- Kana mushonga wacho wakagamuchirwa waiva wakanyanya, varwere vanogona kuona zviratidzo zvakakomba zveHYPERTHYROIDISM zvakadai sekurwadziwa kwepfungwa, kutapudza mwoyo, kana chironga chemwoyo. Kune vanorwara vane chirwere chemwoyo, kunyange kuwedzera kuduku mumuviri we levothyroxine sodium kunogona kuva nengozi. Uye zvidzidzo zvinoratidza kuti kunyanya kudarika kweevothyroxine sodium yakadai iyo iyo inogona kuitika kubva pakuwedzera simba kunogona kuwedzera ngozi yeosteoporosis nekukonzera subclinical hyperthyroidism.
- Kusiyana kwehutano kunogona kuita kuti kuwedzerwa kuyerwa kwakakwana kunenge kusingaiti. Levothyroxine sodium mapiritsi anouya mumasikirwo emasikirwo ane simba zvakasiyana nemari shoma, iyo inobvumira chiremba wako kuti anonyatsokuwana mukana wakakodzera iwe. Asi kana uwandu hwehutachiona hunoshandiswa mune imwe nhengo yakasiyana, izvo zvinoita kuti uwane nekuchengetedza mukana wakakodzera iwe kunyange zvimwe zvakaoma.
Cherechedzai: Vashandi vezvinodhaka vakapedzisira vaisa iyo NDAs ye levothyroxine, uye levothyroxine, yegore ra2017, iro reDAA rakagamuchirwa.