Levothyroxine Mankhwala Osokoneza Bongo Monga Synthroid Anayenera Kuwonetsa Kukhazikika, Kugwirizana
Mu September 1997, chilengezocho chinagwedeza anthu odwala chithokomiro. Makamaka, izi zakhudza odwala omwe adatenga mankhwala ena omwe amachititsa mankhwalawa monga Synthroid, Levoxyl, ndi ena - pogwiritsa ntchito levothyroxine sodium.
Malingana ndi chilengezo cha Federal Register pa nthawi imeneyo,
... osagulitsidwa pakamwa pamalopo levothyroxine sodium mankhwala wasonyezedwa kuti asonyeze mphamvu yowonjezereka ndi kukhazikika, motero, pakali pano sagulitsidwa mankhwala ovomerezeka ndi levothyroxine sodium yomwe amadziwika kuti ndi yotetezeka komanso yothandiza.
Panthawi imeneyo, boma linapeza kuti mankhwala a levothyroxine sodium nthawi zambiri sanagwiritse ntchito mphamvu zawo patsiku lawo lomaliza, ndipo mapiritsi ofanana mphamvu ya mlingo kuchokera kwa wopanga yemweyo anapezeka kuti amasiyana mosiyanasiyana kuchokera ku maere mpaka kuchuluka chophatikizapo. Kulephera kwa kukhazikika ndi kusasinthasintha koyenera kunayambitsa mavuto aakulu kwa thanzi kwa omwe akumwa mankhwalawa.
Levothyroxine sodium inalowetsedwa msika woyamba mchaka cha 1962, popanda chivomerezo cha "New Drug Application" (NDA), mwachionekere pokhulupirira kuti si mankhwala atsopano.
Kuyambira nthawi imeneyo, pafupifupi aliyense wopanga mankhwala a levothyroxine sodium, omwe akuphatikizidwa ndi Synthroid, ankakonda kukumbukira nthawi zonse zomwe zinali chifukwa cha mavuto kapena mphamvu.
Nthaŵi zina, vuto limakhalapo chifukwa chakuti levothyroxine sodium imakhala yosakhazikika pamaso pa kuwala, kutentha, mpweya, ndi chinyezi.
Pakati pa 1991 ndi 1997, panali mapiritsi osachepera 10 a levothyroxine sodium omwe amakhala ndi mapiritsi 150 komanso oposa 100 miliyoni. Zonsezi koma zochitika chimodzi, zikumbukirozo zinayambika chifukwa mapiritsi adapezeka kuti ndi osavuta kapena chifukwa mapiritsi awo a levothyroxine anataya nthawi yawo isanakwane.
Zotsalira zomwe zidakalipo zinayambika kuti zikhale zopangidwa kwambiri. Panthawi imeneyi, a FDA adaperekanso machenjezo kwa wopanga malonda a mankhwala a sovothyroxine omwe anataya potency pamene amasungidwa pamtunda wapamwamba wa kutenthedwa kwa kutentha, ndipo omwe anali ndi mphamvu 74.7 peresenti mpaka 90.4, m'malo mwa 90% mpaka 110 peresenti yofunika panthawiyo.
Mavuto amakhalanso ndi kusintha kwa kusintha. Chifukwa mankhwalawa anali kugulitsidwa popanda NDA, opanga sankayenera kuitanitsa FDA kuvomereza nthawi iliyonse pamene anasintha mankhwala awo a levothyroxine. Okonzanso anasintha zowonjezera zosakaniza, mawonekedwe a mawonekedwe a mitundu ndi zinthu zina zamagulu, zomwe zimachititsa kusintha kwakukulu, nthawi zina kuwonjezeka kapena kuchepa kwa mphamvu ya 30 peresenti. Zotsatira zake, nthawi zina, anthu omwe ali ndi mlingo womwewo wa zaka anakhala oopsa ndi oledzera - kapena osamalidwa - pamlingo womwewo. Panali umboni wosonyeza kuti opanga opanga apanga kupanga kusintha kwa mitunduyi komwe kumakhudza mphamvu.
Kenaka, patatha zaka 35 atangoyamba kumene, bungwe la US Food and Drug Administration (FDA) la United States linapereka chidziwitso ( Federal Register , pa 14th, 1997) kuti mankhwala opanga mankhwala omwe ali ndi levothyroxine sodium ankawamasulira kuti "mankhwala atsopano" ndipo ankafunika kudutsa Ndondomeko ya NDA chifukwa cha mavuto omwe anawoneka bwino.
Kuti apitirize kulonda mankhwalawa, opanga mankhwalawa amafunika kulemba NDA ndi umboni wotsimikizirika kuti chinthu chilichonse cha kampaniyo ndi chotetezeka, chogwira ntchito, ndipo chimapangidwa m'njira yowonetsetsa kuti zonsezi zikuchitika. Chifukwa mankhwalawa ndi ofunika kwa mamiliyoni ambiri a ku America, a FDA amalola opanga kupitiriza kugulitsa katundu popanda NDA ovomerezeka mpaka pa August 14, 2000, kuti apereke makampani okwanira kuti azichita maphunziro osiyanasiyana a kafukufuku ndikupereka NDAs zawo.
Zotsatira kwa Odwala
Kodi zotsatirazi zakhala zotani kwa odwala kutenga levothyroxine hormone yowonjezeredwa mankhwala?
- Ngakhale pamene dokotala nthawi zonse ankalongosola mankhwala ofanana ndi levothyroxine sodium, amatsitsa mankhwala onse, odwala amathamanga kukalandira mankhwala omwe amasiyana mofulumira ndi mlingo womwe wapatsidwa.
- Ngati mankhwalawa anali ochepa kwambiri, odwala anakhala HYPOTHYROID ndipo anali ndi zizindikiro monga kuvutika maganizo, kutopa, kulemera, kudzimbidwa, kusalekerera, kutupa, komanso kuvutika.
- Ngati mankhwala omwe adalandira anali amphamvu kwambiri, odwala akhoza kukhala ndi zizindikiro zazikulu za HYPERTHYROIDISM monga kupweteka kwa mtima, kupweteka kwa mtima, kapena kugunda kwa mtima. Kwa odwala ali ndi matenda a mtima, ngakhale kuwonjezeka kochepa pa mlingo wa levothyroxine sodium kungakhale koopsa. Ndipo kafukufuku amasonyeza kuti kuchepetsedwa pang'ono kwa levothyroxine sodium monga chomwe chingachitike chifukwa cha kuchuluka kwa potency kungapangitse kuopsa kwa matenda okhudza kutsegula kwa m'mimba mwa kuyambitsa hyperthyroidism.
- Kusiyanitsa kwa potency kungapangitse mlingo woyenera kukhala wosavuta. Levothyroxine mapiritsi a sodium amabwera mu mphamvu za mphamvu zomwe zimasiyana mochepa, zomwe zimalola dokotala wanu kupeza bwinobwino mlingo woyenera kwa inu. Koma pamene kuchuluka kwa mankhwala ogwiritsidwa ntchito komwe kulipo kumakhala kosiyana, kumapangitsa kupeza ndi kusunga mlingo woyenera kwa inu ngakhale zovuta zambiri.
ZOYENERA: Ogulitsa mankhwalawa potsiriza adayika NDAs kwa levothyroxine, ndipo levothyroxine, monga 2017, mankhwala ovomerezeka a FDA.