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I-FDA idonsa zonke izinhlobo ze-ranitidine emakethe yase-U.S

I-FDA idonsa zonke izinhlobo ze-ranitidine emakethe yase-U.SIzindaba

I-Ranitidine, eyaziwa kakhulu ngegama layo lomkhiqizoZantac, ngumuthi owehlisa ukukhiqizwa kwe-asidi esiswini. Kuvame ukuthathwa ukwelapha isilungulela ne-GERD. NgoSepthemba 13, 2019 i-U.S. Food and Drug Administration (FDA) yakhipha a isitatimende imemezela ukutholakala okwaziwayo kokungcola kwe-nitrosamine okubizwa nge-N-nitrosodimethylamine (NDMA) kweminye imithi ye-ranitidine, kufaka ne-Zantac — okwenza ezinye izitolo zezidakamizwa ziyeke ukuthengisa yonke imikhiqizo ye-ranitidine. Ngo-Ephreli 1, 2020, i-FDA yacela abenzi bezidakamizwa ukuthi badonse zonke izinhlobo ze-ranitidine emakethe yase-U.S.





Kungani kukhunjulwa i-ranitidine?

I-FDA ibiphenya i-NDMA kanye nokunye ukungcola kwe-nitrosamine kumfutho wegazi kanye nemithi yokwehluleka kwenhliziyo ebizwa nge-Angiotensin II Receptor Blockers (ARBs) kusukela ngonyaka odlule, kufundeka isitatimende sokuqala. Endabeni yama-ARBs, i-FDA income ukukhunjulwa okuningi njengoba ithola amazinga angamukeleki ama-nitrosamines.



TIsitatimende sokuqala siphethe ngokuthi izivivinyo zokuqala ziqinisekisile ukuthi i-ranitidine iqukethe amazinga aphansi e-NDMA. Lokhu kudale ukuthi izinkampani zemithi i-Novartis (ezenza zombili izinhlobo ze-Zantac kanye nemithi ejwayelekile yemithi ye-ranitidine) ne-Apotex (eyenza iWal-Zan) ikhumbule yonke imikhiqizo yazo ejwayelekile ye-ranitidine edayiswa e-US.

Amaketanga amakhulu ekhemisi akhipha iZantac emashalofini abo. Phakathi ku isitatimende , I-CVS ikubeke kwacaca ukuthi lesi senzo sithathwa ngokuqapha okuningi, futhi isinqumo sokudonsa imikhiqizo ye-ranitidine emashalofini senziwe ngqo ngokuphendula isexwayiso somkhiqizo esivela e-US Food and Drug Administration (FDA) esisho ukuthi i-ranitidine imikhiqizo ingaqukatha i-NDMA esezingeni eliphansi.

NgoSepthemba, uRamzi Yacoub, oyiChief Pharmacy Officer yakwaSingleCare, wachaza, I-FDA isanda kuthola ukungcola kweminye imikhiqizo ye-ranitidine futhi ikhiphe inkumbulo yokuzithandela okwamanje. Lokhu akuthinti yonke imikhiqizo ye-ranitidine okwamanje. I-FDA iyaqhubeka nokuhlola imikhiqizo ye-ranitidine evela ezikhiqizweni ezahlukahlukene ukuze iqhubeke nokuhlola imiphumela emibi engaba khona.



Ngo-Ephreli walo nyaka, i-FDA yamemezela ukuthi ngemuva kophenyo oluqhubekayo, inhlangano yathola amazinga e-NDMA enyuka ngokuhamba kwesikhathi ezimweni ezijwayelekile zokugcina. Amazinga e-NMDA nawo atholakele enyuka kakhulu lapho i-ranitidine igcinwa emazingeni okushisa aphezulu. Okusho ukuthi, abathengi bangavezwa kumanani amakhulu kakhulu we-NDMA. Lokhu okutholakele kwenze i-FDA ukuthi ikhiphe okuqinile khumbula isicelo .

Okufanele ukwenze uma uthatha i-ranitidine

Izigidi zabantu baseMelika zisebenzisa i-ranitidine — amandla kadokotela kanye ne-counter-the-counter - ukudambisa izinkinga ezahlukahlukene zokugaya ukudla. Kungumuthi we-H2 blocker osetshenziswa kakhulu ovimba isenzo se-histamine futhi unciphise ukukhiqizwa kwe-asidi esiswini. Eqinisweni, kuvamile ukuthi abantu bayithathe kabili ngosuku, noma ngaphezulu. Labo okutholakala ukuthi bane-Zollinger-Ellison syndrome bavame ukuthatha i-ranitidine kathathu ngosuku.

I-FDA incoma ukuthi ukhulume nodokotela wakho uma usebenzisa i-ranitidine kadokotela-wamandla ngaphambi kokumisa umuthi. Noma ngubani othatha amandla okuthenga kumele ayeke ukuwathatha, aphenye ezinye izindlela ngosizo lukasokhemisi, bese ebuyisa umuthi ukuze abuyiselwe. Futhi ungabika noma ikuphi ukusabela okuphikisayo noma izingqinamba zekhwalithi kuma-FDA's IMedWatch Uhlelo Olubi Lokubika Imicimbi.



Yiziphi ezinye izindlela?

Yize i-ranitidine ikhunjulwa, noma ngubani odinga i- imithi yokwehlisa i-asidi ngisengathola ukukhululeka. Abanye abavimba i-H2, njenge I-Pepcid futhi I-Tagamet , zisatholakala ngaphezulu kwekhawunta ukuhlinzeka ngesilungulela nokugaya ukudla, futhi akukaze kukhunjulwe.

Ama-antiacid anjenge Ama-Rolaids , Izinsimbi , futhi Mylanta kungaba yizinketho ezinhle zesilungulela nokukhululeka kokugaya ukudla. Ngokwengeziwe, ama-proton pump inhibitors (ama-PPIs) afana ne- I-Nexium , Prilosec , Futhi i-Prevacid nayo inganikeza ukukhululeka ngaphandle kokukhathazeka nge-NDMA. Kodwa-ke, ama-PPIs anamandla kakhulu futhi anemihume ethile okufanele ixoxwe nodokotela wakho.

Khuluma nodokotela wakho kuqala

Lapho ushintsha imithi, khuluma nochwepheshe futhi ufunde amaqiniso mayelana nokuthi yini etholakalayo futhi ethathwa njengenketho ephephile yezidingo zakho ezithile. I-FDA iphakamisa ukucubungula eminye imikhiqizo ye-OTC yesimo sakho, uma kufanele. Ngenxa yokuthi imishanguzo eminingi yokunciphisa i-asidi isetshenziselwa ukwelashwa kwesikhashana, udokotela wakho anganquma futhi ukuyeka umuthi.



Iziguli ezifisa ukuyeka i-ranitidine bese zishintshela kwenye indlela yokwelashwa kufanele zikhulume ngalokhu nodokotela, uDkt Yacoub weluleka. Kuneminye imishanguzo etholakala kulesisigaba esifanayo noma amanye amakilasi ukwelapha isimo sakho — kepha iziguli kufanele zibonane nosokhemisi noma udokotela wazo ngaphambi kokwenza ushintsho.