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FDA ta tuno da metformin wanda aka sake shi

Labarai

Metformin magani ne da aka saba amfani dashi don magance cutar hawan jini wanda cutar prediabetes ko Type 2 ke fama dashi. Baya ga kasancewa maganin ciwon sikari, wani lokacin ana amfani dashi azaman kashe-lakabin zabin magani don polycystic ovary ciwo (PCOS). A ranar Alhamis, 28 ga Mayu, 2020, da Foodasar Abinci da Magunguna ta Amurka (FDA) ta ba da sanarwar tunatarwa na son rai game da shimfida-sako da aka yi na kwayar metformin 500 mg, wanda Apotex da wasu kamfanonin harhada magunguna guda hudu suka samar.

A ranar Janairu 4, 2021, FDA ta sanar cewa tunatarwar ta faɗaɗa zuwa ƙarin masana'antun, siffofi, da kuma abubuwan sarrafawa. Kamfanoni goma sha ɗaya yanzu sun cire 500 MG, 750 MG, da 1000 MG da aka ƙaddamar da sakin kwayar metformin da kuma ƙaddamar da sakin metformin na baka:

Magungunan Amneal
Kamfanin Apotex
AVKARE Inc. (Amneal)
Bayshore Pharmaceuticals, LLC
Denton Pharma, Inc. (Marksans)
Kai tsaye Rx (Marksans)
Magungunan Granules
Magungunan Lupine
Marksans Pharma Limited
Laburarenmu, Inc.
PD-Rx Magunguna (Amneal)
Magungunan PD-Rx (Marksans)
Masana magunguna, Inc. (Marksans)
Kamfanin RemedyRepack Inc. (Marksans)
Sun Pharmaceuticals Industries, Inc.
Magungunan Teva

Me yasa ake tuna metformin ER?

Metformin ER ana tuna shi saboda gwajin da aka samu ya nuna matakan rashin tsarkin nitrosamine, wanda ake kira N-Nitrosodimethylamine (NDMA), waɗanda suke sama da iyakar cin abincin da FDA ta ayyana. Tun daga ƙarshen shekarar 2019 hukumar ke sane da ƙazantar ƙazanta, amma ƙarin binciken da aka yi kwanan nan ya nuna ƙarin mahimman bayanai.

NDMA shine nau'in kwayar cutar wacce ta haifar da tuna ranitidine (wanda galibi aka san shi da sunan sa: Zantac) a farkon wannan shekarar. Yana da gurɓataccen gurɓatacce a cikin ruwa da gasasshen nama ko warke shi. A takaice dai, yawancin mutane suna fuskantar ƙananan matakan NDMA. NDMA na iya shigar da ƙwayoyi yayin masana'antu, marufi, ko aiwatar da ajiya. Ana tsammanin cewa ɗaukar lokaci mai tsawo zuwa ƙarin mahimmin abu na iya zama haɗari-haifar da bayyanar cututtuka kamar jaundice, tashin zuciya, zazzaɓi, da ƙarshe lalacewar hanta ko cutar huhu .

Mun tuna daya da yawa na metformin hydrochloride da aka fadada-fitarwa, bayan da FDA ta Amurka ta gwada shi kuma ta nuna sakamako ga matakan N-Nitrosodimethylamine (NDMA) sama da Acarin Amincewar Daily Intake Limit (ADI), Jordan Berman, Mataimakin Shugaban Apotex, Global Corporate Harkokin, Canji & Dabara, ya fadawa SingleCare. Saboda yawaitar taka tsantsan, mun fadada tunowa ga dukkanin allunan metformin hydrochloride da aka ƙaddamar da saki a cikin Amurka. Apotex ya dakatar da sayar da wannan samfurin a cikin Amurka a cikin watan Fabrairun 2019, kuma ya rage ne kawai a cikin kasuwa. Zuwa yau, ba mu karɓi wani rahoto na munanan abubuwan da suka shafi amfani da samfurin ba.

Dangantaka: Hanyoyin sakamako na Metformin da yadda za'a guje su

Abin da za a yi idan ka ɗauki metformin ER

Ya kamata ku ci gaba da shan metformin ER har sai kun yi magana da likitan ku game da maye gurbin magani. Zai iya zama haɗari a daina amfani da wannan magani kwatsam-musamman lokacin da haɗarin da ke tattare da tuna metformin ya yi ƙasa sosai.

Yanzu da muka gano wasu kayayyakin metformin wadanda basu cika ka'idojinmu ba, muna daukar mataki, in ji Patrizia Cavazzoni, MD, mai rikon mukamin darakta na Cibiyar Bincike da Magunguna ta FDA a cikin sanarwa . Kamar yadda muke yi tun lokacin da aka fara gano wannan ƙazantar, za mu yi magana yayin da sabon bayanin kimiyya ya samu kuma za mu ɗauki ƙarin mataki, idan ya dace.

Dangantaka: Abin da za a yi idan an tuna da maganin ku

Menene madadin?

Tunawa da metformin baya amfani da tsari na-fito da kai tsaye (IR), mafi yawan nau'in da aka tsara na metformin, a cewar FDA. Dukkanin magungunan guda biyu suna da tasiri daidai, kuma metformin IR na iya ma zama mara tsada.Babban bambanci shine cewa kuna iya buƙatar ɗaukar metformin IR sau da yawa kowace rana.

Dangantaka: Metformin vs. Metformin ER

Kawai tuna cewa tuntuɓi likitanka ko likitan magunguna kafin yin canji. Akwai zaɓuɓɓuka da ake da su, amma yana da lafiya kawai don sauya magunguna a ƙarƙashin kulawar mai ba da lafiya.