I-FDA ikhumbula iipilisi zokukhululwa ezandisiweyo ze-metformin

Iindaba

I-Metformin liyeza likagqirha elisetyenziselwa ukunyanga iswekile ephezulu yegazi ebangelwa yi-prediabetes okanye uhlobo lwe-2 yeswekile. Ukongeza ekubeni sisiyobisi seswekile, ngamanye amaxesha sisetyenziswa njenge off-ileyibheli ukhetho lonyango lwe isifo se-ovary polycystic (PCOS). NgoLwesine, ngoMeyi 28, 2020, i United States Ulawulo lokutya kunye neziyobisi (I-FDA) ikhuphe inothisi yokukhumbula ngokuzithandela ukwenziwa kokukhutshelwa okwandisiweyo kweepilisi ze-metformin 500 mg, eziveliswe yi-Apotex kunye nezinye iinkampani zamayeza.

NgoJan. 4, 2021, i-FDA yabhengeza ukuba ukukhumbula kufikelela kubenzi abongezelelweyo, iifom, kunye needosi. Iinkampani ezilishumi elinanye ngoku urhoxe ngokuzithandela i-500 mg, i-750 mg, kunye ne-1000 mg yeepilisi ze-metformin ezandisiweyo kunye nokukhululwa okwandisiweyo kwe-metformin ngomlomo:

• Amayeza amayeza amneal
• Imbuyekezo Apotex Corp
• I-AVKARE Inc. (Amneal)
• IBayshore Pharmaceuticals, LLC
• Imbuyekezo Denton Pharma, Inc.
• I-Rx ngqo (iiMarkans)
• Iigranules zoNyango
• Amayeza oLupine
• Ungathenga okanye uthengise izabelo Marksans Pharma Limited kwintengiselwano yebhanki NYSE
• Iilabhoratri zethu, Inc.
• Amayeza ePD-Rx (Amneal)
• Amayeza ePD-Rx (eMarksans)
• Ukhetho lwaMayeza, Inc. (i-Marksans)
• Iindleko zezabelo RemedyRepack Inc.
• Imbuyekezo Sun Pharmaceuticals Industries, Inc.
• Amayeza eTeva

Kutheni le nto i-metformin ER ikhunjulwa?

IMetformin ER Iyakhunjulwa kuba uvavanyo lufumene amanqanaba e-nitrosamine ukungcola, okubizwa ngokuba yi-N-Nitrosodimethylamine (NDMA), engaphezulu komda wokutya okhethwe ngokukhuselekileyo yi-FDA. I-arhente ibisazi umkhondo wobumdaka ukusukela emva kwexesha kwe-2019, kodwa olunye uviwo kutshanje luveze amanani abalulekileyo.

I-NDMA ikwangumhlaza ofanayo okhokelele kwi ukukhumbula i-ranitidine (ihlala isaziwa ngegama layo lophawu: Zantac) ekuqaleni kwalo nyaka. Ingcoliseko oluqhelekileyo emanzini kunye nenyama eyojiweyo okanye ephilisiweyo. Ngamanye amagama, uninzi lwabantu luchanabeke kumanqanaba asezantsi e-NDMA. I-NDMA inokufaka iziyobisi ngexesha lokwenziwa, ukupakishwa, okanye inkqubo yokugcina. Kukrokrelwa ukuba ukuboniswa kwexesha elide kwixabiso elibalulekileyo kunokuba yingozi-kukhokelela kwiimpawu ezinjenge-jaundice, isicaphucaphu, umkhuhlane, kwaye ekugqibeleni ukulimala kwesibindi okanye umhlaza wemiphunga .

Sikhumbule enye yeepilisi ze-metformin hydrochloride ezandisiweyo, emva kokuba i-US FDA iyivavanyile kwaye yabonisa iziphumo zamanqanaba e-N-Nitrosodimethylamine (NDMA) ngaphezulu kweMida eyamkelekileyo yokuThabatha imihla ngemihla (i-ADI), iJordani Berman, i-Apotex Vice-President, Global Corporate Imicimbi, inguquko kunye neQhinga, uxelele i-SingleCare. Ngenxa yobuninzi bezilumkiso, sandise ukukhumbula kuzo zonke iipilisi zeemetformin hydrochloride ezandisiweyo e-US. I-Apotex iyekile ukuthengisa le mveliso eMelika ngoFebruwari 2019, kwaye kusekho kuphela imveliso encinci kwimarike. Ukuza kuthi ga ngoku, asikazifumani iingxelo zeziganeko ezimbi ezinxulumene nokusetyenziswa kwemveliso.

Ezinxulumene: Iziphumo ebezingalindelekanga zeMetformin kunye nendlela yokuzikhusela

Kufuneka wenze ntoni ukuba uthatha i-metformin ER

Kuya kufuneka uqhubeke uthatha i-metformin ER de uthethe nomboneleli wakho wezonyango malunga nelinye amayeza. Kunokuba yingozi ukuyeka ukusebenzisa la mayeza ngesiquphe-ngakumbi xa umngcipheko onxulumene nokukhumbula i-metformin usezantsi ngokufanelekileyo.

Ngoku njengoko sichonge ezinye iimveliso ze-metformin ezingafikeleliyo kwimigangatho yethu, sithatha inyathelo, utshilo uPatrizia Cavazzoni, MD, umphathi obambeleyo weZiko le-FDA loVavanyo lweeDrug noPhando ingxelo . Njengokuba besisenza oko oko kwaqala kwachongwa oku kungcola, siya kunxibelelana njengoko ulwazi lwenzululwazi lufumaneka kwaye siyakuthatha amanye amanyathelo, ukuba kufanelekile.

Ezinxulumene: Kufuneka wenze ntoni ukuba uyakhumbula amayeza akho

Zeziphi ezinye iindlela?

Ukukhumbula i-metformin akusebenzi kwimixube ekhutshwa kwangoko (i-IR), olona hlobo luqhelekileyo lwe-metformin, ngokwe-FDA. Omabini la mayeza ayasebenza ngokulinganayo, kwaye metformin IR inokuba ibize kakhulu.Umahluko ophambili kukuba ungadinga ukuthatha i-metformin IR rhoqo ngemini.

Ezinxulumene: IMetformin Vs. IMetformin ER

Khawukhumbule nje ukubonisana nogqirha wakho okanye ukhemesti ngaphambi kokwenza utshintsho. Kukho iindlela ezikhoyo, kodwa kukhuselekile kuphela ukutshintsha amayeza phantsi kweliso lomboneleli wezempilo.