I-FDA itsala zonke iintlobo ze-ranitidine kwintengiso yase-US

Iindaba

Iranididine, eyaziwa njengegama layoZantac, liyeza elinciphisa ukuveliswa kwesisu esiswini. Kuqhelekileyo kuthathwa ukunyanga isitshisa kunye ne-GERD. NgoSeptemba 13, 2019 iU.S.Ukutya noLawulo lweziyobisi (i-FDA) yakhupha i-a ingxelo ukubhengeza ubukho bokungcola kwe-nitrosamine ekuthiwa yi-N-nitrosodimethylamine (NDMA) kumayeza athile e-ranitidine, kubandakanya i-Zantac-ibangela ukuba ezinye iivenkile zamachiza ziyeke ukuthengisa zonke iimveliso ze-ranitidine. Ngo-Epreli 1, 2020, i-FDA yacela abenzi beziyobisi ukuba batshale zonke iintlobo ze-ranitidine kwintengiso yase-US.

Kutheni le nto i-ranitidine ikhunjulwa?

I-FDA ibiphanda i-NDMA kunye nokunye ukungcola kwe-nitrosamine kuxinzelelo lwegazi kunye namayeza okusilela kwentliziyo abizwa ngokuba yi-Angiotensin II Receptor Blockers (ARBs) ukusukela kunyaka ophelileyo, ifundwe ingxelo yoqobo. Kwimeko yee-ARBs, i-FDA icebise ukukhumbula okuninzi njengoko ifumene amanqanaba angamkelekanga e-nitrosamines.

TIsiteyitimenti sokuqala saqukumbela ukuba iimvavanyo zokuqala ziqinisekisile ukuba i-ranitidine iqulethe amanqanaba asezantsi e-NDMA. Oku kubangele iinkampani zamachiza i-Novartis (ezenza zombini i-Zantac kunye nohlobo lwe-ranitidine amayeza) kunye ne-Apotex (eyenza iWal-Zan) ukuba ikhumbule zonke iimveliso zazo ze-generic ranitidine ezithengiswa e-US.

Amaketanga amakhulu ekhemesti akhupha iZantac ezishelfini zabo. Kwi ingxelo I-CVS yenze kwacaca ukuba eli nyathelo lithathwa ngaphandle kwesilumkiso, kwaye isigqibo sokutsala iimveliso ze-ranitidine ezishelfini senziwe ngokuthe ngqo ekuphenduleni isilumkiso semveliso evela e-US Food and Drug Administration (FDA) echaza ukuba i-ranitidine iimveliso zinokuba nenqanaba eliphantsi le-NDMA.

Ngo-Septemba, u-Ramzi Yacoub, iGosa eliyiNtloko le-Pharmacy le-SingleCare, ucacisile, I-FDA isandula ukufumanisa ukungcola kwezinye iimveliso ze-ranitidine kwaye ikhuphe ukuzikhethela ngokuzithandela okwangoku. Oku akuchaphazeli zonke iimveliso ze-ranitidine okwangoku. I-FDA iyaqhubeka nokuvavanya iimveliso ze-ranitidine ezivela kwimveliso eyahlukeneyo ukuvavanya ngakumbi iziphumo ezinokubakho.

Ngo-Epreli walo nyaka, i-FDA ibhengeze ukuba emva kophando oluthe kratya, umbutho ufumanise amanqanaba e-NDMA enyuka ngokuhamba kwexesha kwiimeko eziqhelekileyo zokugcina. Amanqanaba e-NMDA afunyanwa ukuba anyuke nangakumbi xa i-ranitidine igcinwe kumaqondo aphezulu obushushu. Intsingiselo, abathengi banokuvezwa nakwizixa ezikhulu ze-NDMA. Ezi zinto zifunyanisiweyo zenze ukuba i-FDA ikhuphe umtsalane ngakumbi khumbula isicelo .

Kufuneka wenze ntoni xa uthatha i-ranitidine

Izigidi zabantu baseMelika zisebenzisa i-ranitidine-amandla amiselweyo kunye ne-counter-counter-ukunciphisa iingxaki ezahlukeneyo zokugaya. Yindlela esetyenziswa ngokubanzi ye-H2 blocker yeebhloko ethintela isenzo se-histamine kunye nokunciphisa ukuveliswa kwe-asidi esiswini. Ngapha koko, kuyinto eqhelekileyo ukuba abantu bayithathe kabini ngemini, okanye nangaphezulu. Abo bafunyaniswe benesifo seZollinger-Ellison badla ngokuthatha i-ranitidine kathathu ngemini.

I-FDA icebisa ukuba uthethe nogqirha wakho ukuba uthatha amayeza-amandla e-ranitidine ngaphambi kokumisa amayeza. Nabani na othatha amandla angaphezulu kwekhawuntari makayeke ukuwuthatha, aphande ezinye iindlela ngoncedo losokhemesti, kwaye abuyisele amayeza ukubuyiselwa imali. Unokuxela naziphi na iimpendulo ezingalunganga okanye imiba esemgangathweni kwi-FDA's IMedWatch Inkqubo yokuXelwa kwezeMeko eziGwenxa.

Zeziphi ezinye iindlela?

Nangona i-ranitidine ikhunjulwa, nabani na ofuna i iyeza lokunciphisa i-asidi usenokufumana isiqabu. Ezinye iibhlokhi zeH2, ezinje nge Ipepcid kwaye I-Tagamet , zisafumaneka ngaphezulu kwekhawuntari ukubonelela ngokuqaqanjelwa yintlungu kunye nokunciphisa isisu, kwaye khange zikhunjulwe.

Iiantacids ezinje nge IiRolaids , Tums , kunye Mylanta Unokuba lukhetho olufanelekileyo lokuqaqamba kwentliziyo kunye nokukhululeka kokuchama. Ukongeza, iiproton pump inhibitors (ii-PPIs) ezinje nge Nexium , Iprilosec , kunye ne-Prevacid inokubonelela ngoncedo ngaphandle kokukhathazeka nge-NDMA. Nangona kunjalo, ii-PPIs zinamandla kwaye zinemiqolomba ekufuneka ixoxwe nogqirha wakho.

Thetha nogqirha wakho kuqala

Xa utshintsha amayeza, thetha nengcali kwaye ufunde iinyani malunga noko kufumanekayo kwaye kuthathelwe ingqalelo ukhetho olukhuselekileyo kwiimfuno zakho ezithile. I-FDA icebisa ukuthathela ingqalelo ezinye iimveliso ze-OTC kwimeko yakho, ukuba kufanelekile. Ngenxa yokuba amayeza amaninzi anciphisa i-asidi asetyenziselwa unyango lwexesha elifutshane, ugqirha wakho unokuthatha isigqibo sokuyeka iyeza.

Izigulana ezinqwenela ukuyeka i-ranitidine kwaye zitshintshele kolunye unyango kufuneka zixoxe ngale ngcali yezonyango, uGqirha Yacoub ucebisa. Kukho amanye amayeza akhoyo kule klasi inye okanye ezinye iiklasi ukunyanga imeko yakho-kodwa abaguli kufuneka babonane nosokhemesti okanye ugqirha ngaphambi kokwenza utshintsho.