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FDA inoyeuka metformin yakawedzerwa-kuburitsa mapiritsi

Nhau

Metformin mushonga unonyorwa unowanzo shandiswa kurapa shuga yakakwira muropa inokonzerwa ne prediabetes kana Type 2 diabetes. Pamusoro pekuve chirwere cheshuga, dzimwe nguva chinoshandiswa se off-label kurapwa nzira ye polycystic ovary chirwere (PCOS). NeChina, Chivabvu 28, 2020, iyo United States Kudya neDrug Administration (FDA) yakaburitsa ziviso yekuzvidira yekuyeuchidza yekuwedzera-kuburitsa kugadzirwa kwemetformin 500 mg mapiritsi, akagadzirwa naApotex nemamwe makambani mana emishonga.

Musi waNdira 4, 2021, iyo FDA yakazivisa kuti kuyeuka kunosvika kune vamwe vagadziri, mafomu, uye madheji. Makambani gumi nerimwe ikozvino vazvipira kubvisa 500 mg, 750 mg, uye 1000 mg yakawedzerwa-kuburitsa metformin mapiritsi uye yakawedzera-kusunungura metformin yekumiswa pamuromo:

Amneal Mishonga
Apotex Corp.
AVKARE Inc. (Amneal)
Bayshore Pharmaceuticals, LLC
Zvikamu Denton Pharma, Inc.
Nongedzera Rx (Marksans)
Granules Mishonga
Lupine Mishonga
Mari yezvikamu Marksans Pharma Limited
Yedu Laboratories, Inc.
PD-Rx Mishonga (Amneal)
PD-Rx Mishonga (Marksans)
Kunakirwa Pharmaceuticals, Inc. (Marksans)
RemedyRepack Inc. (Marksans)
Zuva reMishonga Mishonga, Inc.
Teva Mishonga

Nei metformin ER ichirangarirwa?

Metformin ER iri kurangarirwa nekuti kuyedzwa kwakawanikwa mazinga eitrosamine kusachena, kunodaidzwa kuti N-Nitrosodimethylamine (NDMA), ayo ari pamusoro pemuganho wekutora wakasarudzwa wakachengeteka neFDA. Sangano iri rave richiziva nezve zvisaririra kubva mukunopera kwe2019, asi kumwezve kuongororwa chete kuchangobva kuburitsa huwandu hwakakosha.

NDMA ndiyo imwe carcinogen iyo yakatungamira kune rangarira ye ranitidine (inowanzozivikanwa nezita rayo rezita: Zantac) kutanga kwegore rino. Iyo yakasvibisa yakajairika mumvura uye nyama yakakangwa kana yakaporeswa. Mune mamwe mazwi, vanhu vazhinji vanooneswa kune yakaderera nhanho dzeNNMA. NDMA inogona kupinda mishonga panguva yekugadzira, kurongedza, kana kuita kwekuchengetedza. Zvinofungidzirwa kuti kuratidzwa kwenguva yakareba kune zvimwe zvakakosha kunogona kuva nenjodzi- zvichizounza zviratidzo zvakaita sejaundice, kuda kurutsa, kupisa muviri, uye pakupedzisira kukuvara kwechiropa kana kenza yemapapu .

Takayeuka imwe yakawanda yemetformin hydrochloride yakawedzerwa-kuburitsa mapiritsi, mushure mekunge US FDA yaiyedza uye ikaratidza mhedzisiro yeN-Nitrosodimethylamine (NDMA) mazinga akawandisa Anogamuchirwa Mazuva ese Ekutora Limit (ADI), Jordan Berman, Apotex Mutevedzeri weMutungamiri, Global Corporate Nyaya, Shanduko & Isu, akaudza SingleCare. Kunze kwekuwanda kwekuchenjerera, takawedzera chiyeuchidzo kune ese mazhinji metformin hydrochloride akawedzera-mahwendefa ekuburitsa muUS. Apotex yakamira kutengesa ichi chigadzirwa muU.S. muna Kukadzi 2019, uye kuchingori nechakaganhurirwa chigadzirwa pamusika. Parizvino, hatisati tagamuchira chero mishumo yezviitiko zvakashata zvine chekuita nekushandisa kwechigadzirwa.

Zvaunofanira kuita kana iwe ukatora metformin ER

Iwe unofanirwa kuramba uchitora metformin ER kusvikira iwe wataura kune wako mupi wezvehutano nezve mumwe mushonga wekutsiva. Zvinogona kuva nenjodzi kurega kushandisa mushonga uyu nekukasira-kunyanya kana njodzi inosangana neyekuyeuchidza metformin iri pasi zvishoma.

Zvino zvataona zvimwe zvigadzirwa zve metformin zvisingaenderane nematanho edu, tiri kutora matanho, akadaro Patrizia Cavazzoni, MD, director director weFDA's Center for Drug Evaluation and Research mu chirevo . Sezvatagara tichiita kubva pakusachena uku kwakatanga kuzivikanwa, tichazotaurirana sezvo ruzivo rutsva rwesainzi rwuchizowanikwa uye tichizotora mamwe matanho, kana zvakakodzera

Ndedzipi dzimwe nzira?

Iyo yekuyeuchidza metformin haishande kune ekukurumidza-kuburitsa (IR) mafomati, irwo rwunonyanya kudomwa rudzi rwemetformin, sekureva kweDFA. Mishonga iyi miviri inoshanda zvakaenzana, uye metformin IR inogona kutodhura.Musiyano mukuru ndewekuti iwe ungangoda kutora metformin IR kazhinji pazuva.

RELATED: Metformin Vs. Metformin ER

Ingo rangarira kubvunza chiremba wako kana wemishonga usati waita shanduko. Pane sarudzo dziripo, asi zvakachengeteka chete kushandura mishonga pasi pekutarisirwa kweanopa rubatsiro rwehutano.