Torrent Pharmaceuticals Limited'in \u00fclke \u00e7ap\u0131ndaki geri \u00e7a\u011f\u0131rmas\u0131n\u0131 eser miktarda kansere neden olabilecek potansiyel kanserojen i\u00e7erdi\u011fi tespit edilen iki tansiyon ilac\u0131n\u0131 da i\u00e7erecek \u015fekilde geni\u015fletti\u011fini duyurmas\u0131yla ABD G\u0131da ve \u0130la\u00e7 \u0130daresi'nin g\u00f6n\u00fcll\u00fc tansiyon ila\u00e7lar\u0131n\u0131 geri \u00e7a\u011f\u0131rmas\u0131 devam ediyor.<\/p>\n
\u0130ki ila\u00e7, Hetero Labs Limited taraf\u0131ndan \u00fcretilen 3 lot Losartan Potasyum Tablet USP ve 2 lot Losartan Potasyum\/hidroklorotiyazid tablet, USP'dir. Test s\u0131ras\u0131nda FDA taraf\u0131ndan kabul edilebilir al\u0131m seviyesinin \u00fczerinde N-metilnitrosobutirik asit (NMBA) miktarlar\u0131 tespit edildi.<\/p>\n
Tansiyon ila\u00e7lar\u0131n\u0131n geri \u00e7a\u011fr\u0131lmas\u0131 Temmuz 2018'de FDA'n\u0131n hipertansiyon ve kalp yetmezli\u011fini tedavi etmek i\u00e7in kullan\u0131lan Valsartan, Losartan ve Irbesartan ila\u00e7lar\u0131 da dahil olmak \u00fczere Anjiyotensin II Resept\u00f6r Blokerlerini (ARB'ler) geri \u00e7ekmesiyle ba\u015flad\u0131.<\/p>\n
Bu ila\u00e7lar N-Nitrosodimetilamin (NDMA) veya N-Nitrosodietilamin (NDEA) i\u00e7erebilir ve maruziyet karaci\u011fer kanseri, mide kanseri, ba\u011f\u0131rsak kanseri, kolorektal kanser, b\u00f6brek kanseri veya kan kanserine neden olabilir.<\/p>\n
Bir eczane, baz\u0131 Valsartan \u00fcr\u00fcnlerinde de olas\u0131 kanserojen dimetilformamid (DMF) buldu\u011funu iddia ediyor. Mide ek\u015fimesi, \u00fclser ve gastro\u00f6zofageal refl\u00fc hastal\u0131\u011f\u0131n\u0131 tedavi etmek i\u00e7in Zantac markal\u0131 ranitidin ilac\u0131 da NDMA safs\u0131zl\u0131klar\u0131 nedeniyle geri \u00e7a\u011fr\u0131ld\u0131.<\/p>\n
Bu kirlenme, \u00fcretim s\u00fcrecinde meydana gelir; ila\u00e7lara \u00f6zg\u00fc safs\u0131zl\u0131klar de\u011fildirler.<\/p>\n
Bu ila\u00e7lar\u0131n kullan\u0131c\u0131larda kansere neden olma riskinin ciddiyeti bilinmemektedir, ancak FDA daha \u00f6nce Valsartan kullananlar i\u00e7in bunun olduk\u00e7a d\u00fc\u015f\u00fck oldu\u011funa inand\u0131klar\u0131n\u0131 belirtmi\u015fti.<\/p>\n
\u201cBilim adamlar\u0131m\u0131z, 8.000 ki\u015finin d\u00f6rt y\u0131l boyunca (etkilenen \u00fcr\u00fcnlerin ABD pazar\u0131nda oldu\u011funa inand\u0131\u011f\u0131m\u0131z s\u00fcre) NDMA i\u00e7eren en y\u00fcksek g\u00fcnl\u00fck valsartan dozunu (320 mg) almas\u0131 halinde, bunun \u00f6tesinde bir kanser vakas\u0131 daha olabilece\u011fini tahmin ediyor. Amerikal\u0131lar aras\u0131ndaki ortalama kanser oran\u0131. Etkilenen valsartan\u0131n kullan\u0131m\u0131 yoluyla safs\u0131zl\u0131\u011fa maruz kalan \u00e7o\u011fu hasta, yukar\u0131da a\u00e7\u0131klanan senaryodan daha az maruz kalm\u0131\u015ft\u0131r.<\/em>\u201d FDA belirtilmi\u015f<\/a>.<\/p>\n Uyu\u015fturucu geri \u00e7a\u011f\u0131rmalar\u0131 s\u0131k g\u00f6r\u00fclen olaylard\u0131r ve her zaman bir ilac\u0131n sa\u011fl\u0131k riskleri olu\u015fturdu\u011fu anlam\u0131na gelmez. Bazen bir ila\u00e7, FDA y\u00f6nergelerine uymayan \u00fcretim veya etiketleme nedenlerinden dolay\u0131 kusurlu kabul edilir.<\/p>\n \u0130la\u00e7 geri \u00e7a\u011f\u0131rmalar\u0131, bir ilac\u0131n g\u00fcvenli olmad\u0131\u011f\u0131 veya uygun olmad\u0131\u011f\u0131 d\u00fc\u015f\u00fcn\u00fcld\u00fc\u011f\u00fcnde, ila\u00e7 \u015firketleri taraf\u0131ndan bir ilac\u0131 piyasadan kald\u0131rmak i\u00e7in yap\u0131lan g\u00f6n\u00fcll\u00fc eylemlerdir.<\/p>\n Hat\u0131rlar<\/a> FDA talebiyle veya talebi olmadan ger\u00e7ekle\u015febilir, ancak \u015firketlerin ilac\u0131 geri \u00e7a\u011f\u0131rmas\u0131 gerekir, FDA'n\u0131n b\u00f6yle bir yetkisi yoktur.<\/p>\n \u00dc\u00e7 t\u00fcr geri \u00e7a\u011f\u0131rma s\u0131n\u0131fland\u0131rmas\u0131 vard\u0131r: s\u0131n\u0131f I, ciddi sa\u011fl\u0131k sorunlar\u0131na yol a\u00e7mas\u0131 muhtemel t\u00fcm \u00fcr\u00fcnleri i\u00e7erir; s\u0131n\u0131f II, ge\u00e7ici olarak bir sa\u011fl\u0131k sorununa neden olabilecek herhangi bir \u00fcr\u00fcn\u00fc i\u00e7erir; S\u0131n\u0131f III, bir sa\u011fl\u0131k sorununa yol a\u00e7mas\u0131 muhtemel olmayan ancak ba\u015fka bir \u015fekilde FDA yasalar\u0131n\u0131 ihlal eden herhangi bir \u00fcr\u00fcn\u00fc i\u00e7erir.<\/p>\n FDA t\u00fcm geri \u00e7a\u011f\u0131rmalar\u0131 yay\u0131nlar haftal\u0131k<\/a> Y\u00fcr\u00fctme Raporunda. \u015eu anda safs\u0131zl\u0131klar i\u00e7in ARB'leri test etmeye devam ediyorlar. \u015eirketler genellikle kamuya bir ila\u00e7 geri \u00e7a\u011f\u0131rma duyurusu yapar ve eczac\u0131lar ve sa\u011fl\u0131k uzmanlar\u0131 hastalar\u0131 do\u011frudan bilgilendirir.<\/p>\n Hastalara daha sonra, geri \u00e7a\u011fr\u0131lan ila\u00e7lar\u0131 eczanelerine nas\u0131l iade edecekleri de dahil olmak \u00fczere sonraki ad\u0131mlar konusunda talimat verilir. Torrent Pharmaceuticals Limited \u015fu anda m\u00fc\u015fterilerini ve distrib\u00fct\u00f6rlerini geri \u00e7a\u011f\u0131rma hakk\u0131nda telefon g\u00f6r\u00fc\u015fmeleri, mektuplar ve e-postalar yoluyla bilgilendirmektedir.<\/p>\n ARB geri \u00e7a\u011f\u0131rma i\u015flemine kat\u0131lan \u015firketler \u015funlar\u0131 i\u00e7erir: AS Medication Solutions LLC; Acetris Sa\u011fl\u0131k, LLC; Actavis \u0130la\u00e7 A.\u015e.; Amerikan Sa\u011fl\u0131k Paketleme; Aurobindo Pharma USA, Inc.; AvKare, Inc.; Bryant Ranch Prepack Inc.; Camber \u0130la\u00e7 A.\u015e.; Golden State T\u0131bbi Tedarik; GSMS Anonim \u015eirketi; HJ Harkins Company Inc. \/ Pharma Pac; Miras \u0130la\u00e7 A.\u015e.; Eski \u0130la\u00e7 Ambalaj\u0131, LLC; Macleods \u0130la\u00e7 Ltd.; Ba\u015fl\u0131ca \u0130la\u00e7lar; Mylan \u0130la\u00e7 A.\u015e.; Northwind \u0130la\u00e7; NuCare \u0130la\u00e7 A.\u015e.; Tercih Edilen \u0130la\u00e7lar, Inc.; Prinston Pharmaceutical Inc., dba Solco Healthcare LLC; RemedyRepack Inc.; Sandoz A.\u015e.; Solco Sa\u011fl\u0131k LLC; Teva \u0130la\u00e7 ABD A.\u015e.; Torrent \u0130la\u00e7 Limited \u015eirketi; ve Westminster \u0130la\u00e7lar\u0131.<\/p>\n FDA, geri \u00e7a\u011fr\u0131lan tansiyon ila\u00e7lar\u0131ndan herhangi birini alan hastalara, eczac\u0131lar\u0131 veya doktorlar\u0131 onlara farkl\u0131 bir se\u00e7enek sunana kadar re\u00e7ete edildi\u011fi \u015fekilde almaya devam etmeleri talimat\u0131n\u0131 verdi.<\/p>\n Aniden ila\u00e7 almay\u0131 b\u0131rakmak tehlikelidir.<\/p>\n \u0130la\u00e7lar\u0131n\u0131z\u0131n geri \u00e7a\u011fr\u0131ld\u0131\u011f\u0131ndan emin de\u011filseniz, FDA'y\u0131 kontrol edin. liste<\/a> geri \u00e7a\u011fr\u0131lan ARB'lerin say\u0131s\u0131. \u0130la\u00e7lar\u0131n\u0131z\u0131 ada, \u00fcreticiye, son kullanma tarihine ve parti veya parti numaras\u0131na g\u00f6re aray\u0131n. Geri \u00e7a\u011f\u0131rma, \u00f6zellikle haplar\u0131n\u0131z\u0131n kontamine oldu\u011fu anlam\u0131na gelmeyebilece\u011finden, farkl\u0131 bir markadan veya farkl\u0131 bir partiden olabilir, bunu yapmak \u00f6nemlidir.<\/p>\n ARB re\u00e7ete edilen herhangi bir hasta, g\u00fcncellemeler i\u00e7in d\u00fczenli olarak FDA web sitesini kontrol etmelidir.<\/p>\n \u0130la\u00e7lar\u0131n\u0131zla ilgili sorular\u0131n\u0131z ve endi\u015feleriniz i\u00e7in doktorunuza veya sa\u011fl\u0131k uzman\u0131n\u0131za ba\u015fvurun. Bu geri \u00e7a\u011f\u0131rmayla ilgili t\u0131bbi bir sorunu bildirmeniz gerekirse 1-800-912-9561 numaral\u0131 telefondan Torrent Pharmaceuticals Limited ile ileti\u015fime ge\u00e7in veya Medinfo.Torrent@apcerls.com<\/a>.<\/p>","protected":false},"excerpt":{"rendered":" Torrent Pharmaceuticals Limited'in \u00fclke \u00e7ap\u0131ndaki geri \u00e7a\u011f\u0131rmas\u0131n\u0131 iki tansiyon ilac\u0131n\u0131 i\u00e7erecek \u015fekilde geni\u015fletti\u011fini duyurmas\u0131yla ABD G\u0131da ve \u0130la\u00e7 \u0130daresi'nin g\u00f6n\u00fcll\u00fc tansiyon ila\u00e7lar\u0131n\u0131 geri \u00e7a\u011f\u0131rmas\u0131 devam ediyor...<\/p>","protected":false},"author":3,"featured_media":7974,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[919,926,928,972,973,914,917,918],"class_list":["post-7973","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation","tag-pharmaceutical-injuries-lawyer-new-york","tag-pharmaceutical-law","tag-pharmaceutical-lawsuit-attorney","tag-fda-recall","tag-recall","tag-pharmaceutical-litigation-attorney","tag-pharmaceutical-lawsuit","tag-pharmaceutical-lawyers"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/7973","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/comments?post=7973"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/7973\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media\/7974"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media?parent=7973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/categories?post=7973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/tags?post=7973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}