A FDA amakumbukira mapiritsi otulutsidwa a metformin

Nkhani

Metformin ndi mankhwala akuchipatala omwe amagwiritsidwa ntchito kwambiri pochiza shuga wambiri wamagazi omwe amabwera chifukwa cha prediabetes kapena Type 2 diabetes. Kuphatikiza pa kukhala mankhwala a shuga, nthawi zina amagwiritsidwa ntchito ngati osalemba chithandizo chothandizira matenda a polycystic ovary (PCOS). Lachinayi, Meyi 28, 2020, the United States Chakudya ndi Mankhwala Osokoneza Bongo (FDA) idapereka chidziwitso chokumbukira mwakufuna kwawo pakupanga kwa mapiritsi a metformin 500 mg, opangidwa ndi Apotex ndi makampani ena anayi azachipatala.

Pa Januware 4, 2021, a FDA adalengeza kuti kukumbukiraku kumafikira opanga ena, mafomu, ndi Mlingo. Makampani khumi ndi mmodzi mwadzidzidzi achotsa 500 mg, 750 mg, ndi 1000 mg mapiritsi otulutsa metformin ndikutulutsa kwakanthawi metformin kuyimitsidwa pakamwa:

• Amneal Mankhwala
• Mtengo wa magawo Apotex Corp.
• Opanga: AVKARE Inc. (Amneal)
• Bayshore Pharmaceuticals, LLC
• Malingaliro a kampani Denton Pharma, Inc.
• Direct Rx (Marksans)
• Granules Mankhwala
• Mankhwala a Lupine
• Malingaliro a kampani Marksans Pharma Limited
• Zagawo za Laboratories, Inc.
• PD-Rx Mankhwala (Amneal)
• Mankhwala a PD-Rx (Marksans)
• Malingaliro a kampaniyo Preferred Pharmaceuticals, Inc.
• RemedyRepack Inc. (Maliko)
• Zotsatira Sun Pharmaceuticals Industries, Inc.
• Mankhwala Anu

Chifukwa chiyani metformin ER ikukumbukiridwa?

Metformin ER ikukumbukiridwa chifukwa kuyezetsa kunapezeka kuchuluka kwa nitrosamine, yotchedwa N-Nitrosodimethylamine (NDMA), yomwe ili pamwamba pa malire omwe adalowetsedwa ndi FDA. Bungweli lakhala likudziwa za zodetsa kuyambira kumapeto kwa 2019, koma kuwunikanso kwaposachedwa kwatulutsa zochulukirapo.

NDMA ndi khansa yofananira yomwe idatsogolera ku kukumbukira kwa ranitidine (yomwe imadziwika kuti dzina lake: Zantac) koyambirira kwa chaka chino. Ndi mankhwala owopsa m'madzi ndi nyama zokazinga kapena zochiritsidwa. Mwanjira ina, anthu ambiri amakhala pansi pa NDMA. NDMA imatha kulowa mumankhwala osokoneza bongo panthawi yopanga, kulongedza, kapena kusunga. Akukhulupirira kuti kuwonongera ndalama zochulukirapo nthawi yayitali kumatha kukhala koopsa-kumabweretsa zizindikilo monga jaundice, nseru, malungo, ndipo pamapeto pake kuwonongeka kwa chiwindi kapena khansa yamapapo .

Tidakumbukira mapiritsi ambiri otulutsidwa a metformin hydrochloride, a US FDA atawayesa ndikuwonetsa zotsatira za milingo ya N-Nitrosodimethylamine (NDMA) yopitilira muyeso wa Acceptable Daily Intake Limit (ADI), Jordan Berman, Apotex Wachiwiri kwa Purezidenti, Global Corporate Nkhani, Kusintha & Njira, adauza SingleCare. Chifukwa cha kusamala kwambiri, tidakumbutsa kukumbukira kwa mapiritsi ambiri a metformin hydrochloride ku US. Apotex anasiya kugulitsa izi ku US mu February 2019, ndipo zotsalira ndizochepa pamsika. Pakadali pano, sitidalandirepo chilichonse chokhudzana ndi kugwiritsidwa ntchito kwa malonda.

ZOKHUDZA: Zotsatira za Metformin ndi momwe mungapewere

Zomwe muyenera kuchita mukatenga metformin ER

Muyenera kupitiriza kumwa metformin ER mpaka mutalankhula ndi omwe amakuthandizani pazachipatala. Kungakhale koopsa kusiya kugwiritsa ntchito mankhwalawa mwadzidzidzi-makamaka ngati chiwopsezo chokhudzana ndi kukumbukira kwa metformin sichotsika.

Tsopano popeza tazindikira mankhwala ena a metformin omwe sakukwaniritsa miyezo yathu, tikuchitapo kanthu, atero a Patrizia Cavazzoni, MD, director director of the FDA's Center for Drug Evaluation and Research in a mawu . Monga takhala tikuchita kuyambira pomwe chidetsochi chidadziwika koyamba, tidzalumikizana pomwe zambiri zasayansi zikupezeka ndipo tidzachitapo kanthu ngati kuli koyenera.

ZOKHUDZA: Zomwe muyenera kuchita ngati mankhwala anu akukumbukiridwani

Kodi njira zina ndi ziti?

Kukumbukira kwa metformin sikugwira ntchito pazomwe zimatulutsidwa posachedwa (IR), mtundu wofotokozedwa kwambiri wa metformin, malinga ndi FDA. Mankhwala onsewa ndi ofanana, ndipo metformin IR itha kukhala yotsika mtengo.Kusiyanitsa kwakukulu ndikuti mungafunike kutenga metformin IR pafupipafupi patsiku.

ZOKHUDZA: Metformin motsutsana. Metformin ER

Ingokumbukirani kuti mufunsane ndi dokotala kapena wamankhwala musanachite kusintha. Pali zosankha zomwe zilipo, koma ndibwino kuti musinthe mankhwala moyang'aniridwa ndi wothandizira zaumoyo.