FDA ta 1997 Kira don maganin maganin karoid don tafiyar da hanyar amincewa

Lemothyroxine Drugs Like Synthroid Dole ne Ya nuna Stability, Daidaita

A watan Satumba na shekarar 1997, sanarwa ya girgiza magungunan thyroid patient. Musamman ma, ya shafi marasa lafiya wadanda ke shan daya daga cikin maganin maye gurbin maganin hormone wanda ke kama da Synthroid, Levoxyl, da sauransu - bisa levothyroxine sodium.

A cewar wata sanarwar Tarayya a lokacin,

... ba a halin yanzu ana sayar da samfurin levothyroxine ba, don nuna rashin daidaito da kwanciyar hankali, kuma, a halin yanzu, ba a sayar da samfurin levothyroxine samfur ba a matsayin mai lafiya da tasiri.

A wannan lokacin, gwamnati ta gano cewa magungunan sodium levothyroxine ba su kasance masu karfi ba a lokacin kwanakin kare su, kuma an gano dukkanin nau'ikan irin wannan samfurin daga wannan kamfani don su bambanta a cikin aiki daga kuri'a zuwa yawa a cikin yawan aiki sashi mai samuwa. Wannan rashin kwanciyar hankali da karfin hali na iya haifar da mummunan sakamako ga wadanda ke shan kwayoyi.

An fara gabatar da sodium Levothyroxine a kasuwar kafin 1962, ba tare da an amince da shi "New Drug Application" (NDA) ba, a fili yana ganin cewa ba sabuwar magani bane.

Tun daga wannan lokacin, kusan dukkanin masana'antun da aka yi amfani da su na levothyroxine, irin su Synthroid, sun ruwaito akai-akai cewa sune sakamakon matsala ko matsaloli na zaman lafiya.

A wasu lokuta, matsaloli suna haifar da gaskiyar cewa levothyroxine sodium ba shi da ƙarfi a gaban haske, zazzabi, iska, da kuma zafi.

A lokacin tsakanin 1991 zuwa 1997, ba a yi la'akari da su 10 da ake kira levothyroxine sodium Allunan dauke da lambobin 150 da fiye da miliyan 100. A cikin dukkanin batutuwan da aka fara, an fara tunawa da shi saboda an gano alamun su zama ƙaddamarwa ko saboda ƙananan levothyroxine sunyi hasara kafin kwanakin kwaninsu.

Sauran ragowar aka fara don samfurin da aka samo ya zama mawuyacin hali. A wannan lokacin, FDA ta ba da gargadi ga mai sayar da kayan levothyroxine wanda ya rasa damar aiki yayin da aka adana shi a matsayi mafi girma na tashar zazzabi da aka ba da shawarar, kuma wanda ƙarfinsa ya fito daga 74.7 bisa dari zuwa 90.4, maimakon 90 zuwa 110 kashi da ake bukata a wannan lokacin.

Matsalolin da suka shafi asali suna canzawa. Saboda ana sayar da waɗannan kayayyakin ba tare da NDA ba, masana'antun ba su da izinin amincewar FDA a duk lokacin da suka sake fasalin kayan levothyroxine sodium. Masu sarrafawa sun canza nauyin sinadarai, nau'i na masu launi da wasu nau'ikan samfurori, wanda ya haifar da canje-canje mai mahimmanci a cikin aiki, a wasu lokuta karuwa ko rage yawan aiki ta hanyar kashi 30 cikin 100. A sakamakon haka, a wasu lokuta, mutane a kan wannan samfuri na shekaru sun zama masu guba kuma sun shafe su - ko kuma basu da kariya - a kan wannan kashi. Akwai tabbacin cewa masana'antun sun ci gaba da yin irin waɗannan nau'o'in da suka shafi tasirin.

Bayan haka, shekaru 35 bayan gabatarwar su, Gwamnatin Amurka ta ba da sanarwar ( Federal Register , Agusta 14, 1997) cewa an yi amfani da maganin miyagun ƙwayoyi masu rai da ke dauke da levothyroxine sodium a matsayin "sababbin kwayoyi" kuma ana buƙata su shiga tsari na NDA saboda matsalar zaman lafiya da rashin aiki wanda ya zo da haske.



Don ci gaba da sayar da wadannan kwayoyi, masu sana'a sun buƙaci gabatar da NDA tare da bayanan da aka rubuta cewa duk wani samfurin kamfanin yana da lafiya, inganci, kuma aka yi ta hanyar tabbatar da daidaito. Saboda miyagun ƙwayoyi ya zama wajibi ga miliyoyin Amirkawa, FDA ta yarda wa masana'antun su ci gaba da sayar da wadannan samfurori ba tare da amincewa da NDA ba har zuwa ranar 14 ga watan Agusta, 2000, don bawa kamfanonin damar isa su gudanar da bincike-bincike daban-daban da kuma mika su ga NDA.

Abubuwan da ke faruwa ga marasa lafiya

Menene abubuwan da wadannan abubuwan suka faru na ga marasa lafiya ɗauke da levothyroxine Thyroid hormone substituting products?

NOTE: Ma'aikatan miyagun ƙwayoyi sun ƙaddamar da NDAs don levothyroxine, kuma levothyroxine shine, tun daga shekara ta 2017, wata likita ta FDA.