{"id":8185,"date":"2020-06-04T13:29:26","date_gmt":"2020-06-04T17:29:26","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/headaches-ahead-for-zantac-labs\/"},"modified":"2020-06-04T13:29:26","modified_gmt":"2020-06-04T17:29:26","slug":"zantac-laboratuvarlarinda-ileride-bas-agrisi","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/tr\/article\/zantac-laboratuvarlarinda-ileride-bas-agrisi\/","title":{"rendered":"Zantac Labs \u0130\u00e7in \u00d6n\u00fcm\u00fczdeki Ba\u015f A\u011fr\u0131lar\u0131"},"content":{"rendered":"

mide ek\u015fimesi cennet<\/strong><\/h2>\n

A\u011fustos 2019 gibi yak\u0131n bir tarihte, ranitidin piyasas\u0131n\u0131n 2026 y\u0131l\u0131na kadar mide buland\u0131r\u0131c\u0131 US$ 485,4 milyonu a\u015faca\u011f\u0131 tahmin ediliyordu.<\/p>\n

1981'de piyasaya s\u00fcr\u00fclen bu pop\u00fcler antasit - daha \u00e7ok Zantac olarak bilinir - sadece alt\u0131 y\u0131l sonra d\u00fcnyan\u0131n en \u00e7ok satan re\u00e7eteli ilac\u0131 oldu.<\/p>\n

Asl\u0131nda, d\u00fcnyan\u0131n ek\u015fi midelerini tatland\u0131rmak, e\u015fi benzeri g\u00f6r\u00fclmemi\u015f k\u00e2rlar\u0131n dipsiz bir kuyusunu kan\u0131tlad\u0131 ve Zantac, $ 1 milyar dolar\u0131 a\u015fan sat\u0131\u015flar sa\u011flayan ilk ila\u00e7 oldu.<\/p>\n

1980'lerden itibaren istikrarl\u0131 bir \u015fekilde y\u00fckselen sat\u0131\u015f rakamlar\u0131yla, sindirim bozukluklar\u0131, s\u00fcregelen k\u00fcresel ba\u015far\u0131ya giden kesin bir yol gibi g\u00f6r\u00fcn\u00fcyordu.<\/p>\n

A\u011fustos 2018'de, bu k\u00f6p\u00fcren pazara en son giri\u015f, Granules India Ltd taraf\u0131ndan yap\u0131lan ve A\u011fustos 2018'de FDA taraf\u0131ndan Sanofi-Aventis taraf\u0131ndan \u00fcretilen 150 mg Zantac tabletlere biyoe\u015fde\u011fer oldu\u011fu onaylanan bir OTC ranitidin jeneri\u011fi olan jenerik 150 mg Cool Mint idi.<\/p>\n

Ek\u015fi gidiyor<\/strong><\/h2>\n

Ancak bu kabarc\u0131kl\u0131 \u015fato, ertesi y\u0131l, FDA'n\u0131n Eyl\u00fcl ay\u0131nda yapt\u0131\u011f\u0131 bir duyurunun aralar\u0131ndaki ba\u011flant\u0131y\u0131 vurgulamas\u0131 \u00fczerine par\u00e7alanmaya ba\u015flad\u0131. kanser<\/a> ve bir Zantac bile\u015feni (NDMA).<\/p>\n

Yaln\u0131zca bir \u00fcretici taraf\u0131ndan \u00fcretilen belirli partileri kapsamas\u0131na ra\u011fmen, bu k\u0131rm\u0131z\u0131 \u0131\u015f\u0131k bir\u00e7ok Main Street perakendecisini (CVS ve Walgreens gibi) Zantac'\u0131 ve onun OTC jenerik \u00fcr\u00fcnlerini raflar\u0131ndan \u00e7ekmeye sevk etti.<\/p>\n

G\u00fcvenli\u011fine ili\u015fkin \u015f\u00fcpheler daha da b\u00fcy\u00fcd\u00fc\u011f\u00fcnden, Sandoz (Novartis), GlaxoSmithKlein (GSK) ve Apotex gibi jenerik ila\u00e7 \u00fcreticileri de ranitidin hidroklor\u00fcr \u00fcr\u00fcnlerini geri \u00e7a\u011f\u0131rd\u0131.<\/p>\n

Ertesi ay, d\u00fcnyan\u0131n en b\u00fcy\u00fck jenerik ila\u00e7 \u00fcreticisi Teva Pharmaceuticals Birle\u015fik Krall\u0131k'taki ranitidin partilerini geri \u00e7a\u011f\u0131r\u0131rken, Sanofi Kanada ve ABD'deki \u00fcr\u00fcnleri geri \u00e7a\u011f\u0131rd\u0131.<\/p>\n

O zamandan beri, en az 22 \u00fclke ranitidin hidroklor\u00fcr\u00fc yasaklayarak, bloke ederek veya geri \u00e7a\u011f\u0131rarak davay\u0131 takip ederken, di\u011fer d\u00f6rd\u00fc uyar\u0131larda bulundu ve kendi soru\u015fturmalar\u0131n\u0131 ba\u015flatt\u0131.<\/p>\n

Ocak 2020'de FDA, iki re\u00e7eteli ranitidin t\u00fcr\u00fcn\u00fc daha geri \u00e7a\u011f\u0131rd\u0131 ve Nisan 2020'de Zantac dahil bu ilac\u0131n t\u00fcm re\u00e7eteli ve OTC formlar\u0131n\u0131 yasaklad\u0131.<\/p>\n

Uzun zamand\u0131r favori<\/strong><\/h2>\n

Zantac, k\u0131rk y\u0131ld\u0131r safral\u0131 mideleri asit \u00fcretim sinyallerinden koruyor.<\/p>\n

Daha yayg\u0131n ranitidin markalar\u0131ndan baz\u0131lar\u0131 aras\u0131nda Zantac (\u00e7e\u015fitli g\u00fc\u00e7lerde ve tatlarda); Wal-Zan, Mide Ek\u015fimesini Giderici, Asit D\u00fc\u015f\u00fcr\u00fcc\u00fc ve Asit Kontrol\u00fc.<\/p>\n

Mide asidini kontrol alt\u0131na alan ila\u00e7lar\u0131n histamin H2-resept\u00f6r antagonisti s\u0131n\u0131f\u0131na ait olan Zantac, mideye asit \u00fcretmesini s\u00f6yleyen sinyali bloke eden bir H2 blokerdir.<\/p>\n

Re\u00e7eteli ve re\u00e7etesiz sat\u0131lan ve genellikle mide ek\u015fimesi, asit refl\u00fc, \u00fclser ve di\u011fer sindirim sorunlar\u0131 i\u00e7in al\u0131nan Zantac, alerji tedavilerini de destekleyebilir.<\/p>\n

karanl\u0131k tarih<\/strong><\/h2>\n

1980'li y\u0131llara dayanan bir\u00e7ok \u00e7al\u0131\u015fmalar<\/a> ranitidin'de kanser ve NDMA aras\u0131ndaki ba\u011flant\u0131lar\u0131 g\u00f6sterdi.<\/p>\n

Ayr\u0131ca, Zantac'\u0131 \u00fcreten iki B\u00fcy\u00fck \u0130la\u00e7 firmas\u0131n\u0131n (Sanofi ve Boehringer Ingelheim) bu ba\u011flant\u0131lar\u0131 basit mide yanmas\u0131ndan gastro\u00f6zofageal refl\u00fc hastal\u0131\u011f\u0131na (G\u00d6RH) kadar de\u011fi\u015fen rahats\u0131zl\u0131klar i\u00e7in bu ilac\u0131 alan milyonlarca hastadan gizledi\u011fine dair artan kan\u0131tlar var.<\/p>\n

Ranitidin'de kabul edilemeyecek kadar y\u00fcksek NMDA seviyeleri bulan iki laboratuvar - Emory Pharma ve Valisure (satt\u0131\u011f\u0131 ila\u00e7lar\u0131 toplu olarak test eden \u00e7evrimi\u00e7i bir eczane) - FDA'y\u0131 sat\u0131\u015flar\u0131 ask\u0131ya almaya \u00e7a\u011f\u0131ran vatanda\u015f dilek\u00e7eleri verdi.<\/p>\n

FDA, yayg\u0131n olarak kullan\u0131lan Zantac 150 tabletlerini test ederken, NMDA'n\u0131n g\u00fcnl\u00fck al\u0131m tavan\u0131ndan 3.000 kat daha y\u00fcksek seviyelerde oldu\u011funu buldu.<\/p>\n

G\u00fcn\u00fcm\u00fczde insan t\u00fcketimi i\u00e7in g\u00fcvenli bir NDMA seviyesinin olmad\u0131\u011f\u0131na inan\u0131lmaktad\u0131r.<\/p>\n

Bu if\u015faat\u0131n ard\u0131ndan binlerce kanser hastas\u0131, insan hayat\u0131n\u0131 pervas\u0131zca hi\u00e7e sayarak k\u00e2rlar\u0131n\u0131 insanlar\u0131n \u00f6n\u00fcne koymaya istekli olduklar\u0131 i\u00e7in Sanofi ve Boehringer Ingelheim'a dava a\u00e7arak tazminat talep ediyor.<\/p>\n

Buna kar\u015f\u0131l\u0131k, her iki laboratuvar da Zantac'\u0131 sat\u0131n alan t\u00fcketicilere para iadesi teklif etti.<\/p>\n

NMDA nedir?<\/strong><\/h2>\n

\u00dc\u00e7\u00fcnc\u00fc taraf laboratuvarlardan al\u0131nan bilgilerle y\u00f6nlendirilen ilave FDA testleri ve de\u011ferlendirmeleri, N-Nitrosodimetilamin (NDMA) d\u00fczeylerinin normal saklama ko\u015fullar\u0131nda bile ranitidin i\u00e7inde artabilece\u011fini do\u011frulad\u0131.<\/p>\n

Da\u011f\u0131t\u0131m ve t\u00fcketicilere te\u015fhir s\u0131ras\u0131nda kontrol edilmesi daha zor olan daha y\u00fcksek s\u0131cakl\u0131klarda NDMA \u00f6nemli \u00f6l\u00e7\u00fcde artabilir.<\/p>\n

Bu safs\u0131zl\u0131klar ya\u015fla birlikte artt\u0131\u011f\u0131ndan, eski ranitidin ila\u00e7lar\u0131, \u00f6zellikle oda s\u0131cakl\u0131\u011f\u0131ndan daha y\u00fcksek bir s\u0131cakl\u0131kta sakland\u0131\u011f\u0131nda, g\u00fcnl\u00fck al\u0131m tavan\u0131ndan daha fazla NDMA i\u00e7erebilir.<\/p>\n

Bu, t\u00fcketicinin bu insan kanserojeninin kabul edilemez seviyelerine maruz kalmas\u0131na yol a\u00e7abilir.<\/p>\n

COVID-19 k\u0131s\u0131tlamas\u0131 hen\u00fcz tam olarak kald\u0131r\u0131lmad\u0131\u011f\u0131ndan, t\u00fcketicilerden kullan\u0131lmam\u0131\u015f tabletleri prospekt\u00fcste \u00f6nerildi\u011fi \u015fekilde g\u00fcvenli bir \u015fekilde atmalar\u0131 veya FDA tavsiyelerine uymalar\u0131 isteniyor.<\/p>\n

\u00c7e\u015fitli yan etkiler<\/strong><\/h2>\n

Genellikle hafif olmas\u0131na ra\u011fmen, ranitidinin baz\u0131 yan etkileri ba\u015f a\u011fr\u0131s\u0131, mide bulant\u0131s\u0131 ve kusma gibi \u00f6nemli s\u0131k\u0131nt\u0131ya neden olabilir.<\/p>\n

Bilinen bir kanserojen olan \u00e7ok daha ciddi, y\u00fcksek NDMA seviyeleri prostat, testis ve mesane kanserleri dahil olmak \u00fczere neredeyse t\u00fcm v\u00fccutta kansere neden olabilir; meme, rahim a\u011fz\u0131 ve yumurtal\u0131k kanserleri; b\u00f6brek, karaci\u011fer, mide ve ba\u011f\u0131rsak kanserleri; ve g\u0131rtlak, yemek borusu ve akci\u011fer kanserleri - sigara i\u00e7meyenler aras\u0131nda bile!<\/p>\n

Alternatif ila\u00e7lar<\/strong><\/h2>\n

Ranitidin alan ki\u015filere, sa\u011fl\u0131k uzmanlar\u0131yla birlikte di\u011fer tedavi se\u00e7eneklerini ke\u015ffetmeleri tavsiye edilir, \u00e7\u00fcnk\u00fc di\u011fer bir\u00e7ok ila\u00e7 benzer ama\u00e7lar i\u00e7in onaylanm\u0131\u015ft\u0131r, ancak kanser riski yoktur.<\/p>\n

\u015eimdiye kadar FDA testleri, Pepcid (famotidin) ve Tagamet (simetidin) gibi di\u011fer H2 blokerlerinde NDMA bulmad\u0131.<\/p>\n

Di\u011fer se\u00e7enekler aras\u0131nda Nexium (esomeprazol), Prevacid (lansoprazol) ve Prilosec (omeprazol) gibi proton pompas\u0131 inhibit\u00f6rleri (PPI'ler) bulunur.<\/p>\n

Uyanma \u00e7a\u011fr\u0131s\u0131?<\/strong><\/h2>\n

Baz\u0131 hastalar bu ila\u00e7lar\u0131 almaya ba\u015flad\u0131\u011f\u0131nda ve birka\u00e7 yan etki fark etti\u011finde, asla durmayabilirler.<\/p>\n

Genellikle iyi tolere edilmelerine ra\u011fmen, uzun vadede mide ek\u015fimesi ile ba\u015fa \u00e7\u0131kmak i\u00e7in gerekli olmayabilirler.<\/p>\n

S\u00fcrd\u00fcrmenin zor olmas\u0131na ra\u011fmen, ya\u015fam tarz\u0131 de\u011fi\u015fiklikleri H2 blokerleri ve \u00dcFE'lere olan ihtiyac\u0131 azaltmaya yard\u0131mc\u0131 olabilir.<\/p>\n

Ya\u011fl\u0131 ve baharatl\u0131 yiyeceklerden, alkolden, kafeinden, \u00e7ikolatadan ve gazl\u0131 i\u00e7eceklerden ka\u00e7\u0131nmak, daha k\u00fc\u00e7\u00fck \u00f6\u011f\u00fcnler yemek ve kilo vermekle birlikte bariz bir karard\u0131r.<\/p>\n

Belki uygulamas\u0131 daha kolay, bol giysiler giymek, yemek yedikten sonra birka\u00e7 saat uzanmamak ve hafif e\u011fimli bir yatakta uyumak asit geri ak\u0131\u015f\u0131n\u0131 \u00f6nlemeye yard\u0131mc\u0131 olan basit ad\u0131mlard\u0131r.<\/p>\n

Zantac davalar\u0131<\/strong><\/h2>\n

Onlarca y\u0131ld\u0131r hem re\u00e7eteli hem de re\u00e7etesiz sat\u0131lan bir ila\u00e7 olarak sat\u0131lan herhangi bir Zantac davas\u0131nda, her biri ayr\u0131 bir dava a\u00e7an y\u00fczbinlerce potansiyel davac\u0131 vard\u0131r.<\/p>\n

Ancak bu yarg\u0131lamalar, yarg\u0131lama \u00f6ncesi a\u015famada her davaya bakan tek bir yarg\u0131\u00e7 alt\u0131nda \u00e7ok b\u00f6lgeli davada (MDL) birle\u015ftirilerek kolayla\u015ft\u0131r\u0131ld\u0131.<\/p>\n

\u00d6nc\u00fc denemeler olarak bilinen, anla\u015fmalar\u0131n yap\u0131l\u0131p yap\u0131lmayaca\u011f\u0131n\u0131 ve ne kadara verilece\u011fini belirlemek i\u00e7in birka\u00e7 ilk dava duyulur.<\/p>\n

Bu kararlar, bireysel fakt\u00f6rlere ba\u011fl\u0131 olarak her bir davac\u0131n\u0131n ne kadar alaca\u011f\u0131na rehberlik eder.<\/p>\n

\u015eu anda West Palm Beach'te dosyalanan yaln\u0131zca bir Zantac MBL (N\u00ba 2924) var, Yarg\u0131\u00e7 Robin L Rosenberg taraf\u0131ndan dinleniyor.<\/p>\n

\u015eimdiye kadar san\u0131klar aras\u0131nda GlaxoSmithKline, Sanofi-Aventis, Pfizer Boehringer Ingelheim ve Chattern yer al\u0131yor.<\/p>\n

Sadece birka\u00e7 haftad\u0131r devam etmesine ra\u011fmen, iddialar art\u0131yor.<\/p>\n

Bir uygulama ve prosed\u00fcrler ekibi, \u00f6n\u00fcm\u00fczdeki y\u0131llarda beklenen on binlerce davay\u0131 ele almak i\u00e7in halihaz\u0131rda dava protokolleri ve metodolojisi olu\u015fturuyor.<\/p>\n

Ayr\u0131ca, baz\u0131 kan bas\u0131nc\u0131 ila\u00e7lar\u0131nda da NMDA tespit edilmi\u015ftir ve bu da - bazen yolun a\u015fa\u011f\u0131s\u0131nda - FDA yasa\u011f\u0131n\u0131n daha pahal\u0131 sonu\u00e7lar\u0131ndan birini kan\u0131tlayabilir.<\/p>\n

Belki de 1998'deki t\u00fct\u00fcn ana uzla\u015fma anla\u015fmas\u0131 \u00f6d\u00fcl\u00fc olan 206 milyar ABD Dolar\u0131n\u0131 ge\u00e7ememekle birlikte, Zantac \u00f6demesinin ila\u00e7 sekt\u00f6r\u00fcnde yeni bir rekor k\u0131rmas\u0131 ve Glaxo'nun antidepresanlar\u0131n\u0131 yanl\u0131\u015f tan\u0131tt\u0131\u011f\u0131 i\u00e7in 2012'de \u00f6dedi\u011fi $ 3 milyar ABD Dolar\u0131n\u0131 geride b\u0131rakmas\u0131 i\u00e7in adil bir \u015fans var.<\/p>\n

Bu a\u015famada Zantac yasa\u011f\u0131n\u0131n t\u0131bbi, hukuki ve mali sonu\u00e7lar\u0131 tahmin edilemeyecek kadar geni\u015f.<\/p>\n

Bununla birlikte, bu pop\u00fcler antasitleri yapan laboratuvarlar\u0131n y\u00f6netiminin, ABD Mahkemelerini kas\u0131p kavurmak \u00fczere olan sa\u011flam temellere dayanan iddialar\u0131n ate\u015f f\u0131rt\u0131nas\u0131n\u0131n neden oldu\u011fu dispeptik rahats\u0131zl\u0131\u011f\u0131 yat\u0131\u015ft\u0131rmak i\u00e7in \u00e7ok daha g\u00fc\u00e7l\u00fc \u00e7arelere ihtiyac\u0131 olacak gibi g\u00f6r\u00fcn\u00fcyor.<\/p>","protected":false},"excerpt":{"rendered":"

Mide Ek\u015fimesi Cenneti A\u011fustos 2019 gibi yak\u0131n bir tarihte, ranitidin piyasas\u0131n\u0131n 2026 y\u0131l\u0131na kadar mide buland\u0131r\u0131c\u0131 US$ 485,4 milyonu a\u015fmas\u0131 bekleniyordu.<\/p>","protected":false},"author":3,"featured_media":8186,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[875,877,914,917,918,919,926,928,978,1012],"class_list":["post-8185","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation","tag-bad-drugs","tag-drug-side-effects","tag-pharmaceutical-litigation-attorney","tag-pharmaceutical-lawsuit","tag-pharmaceutical-lawyers","tag-pharmaceutical-injuries-lawyer-new-york","tag-pharmaceutical-law","tag-pharmaceutical-lawsuit-attorney","tag-fda-warning","tag-zantac-injury-attorneys"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8185","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=8185"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8185\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media\/8186"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media?parent=8185"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/categories?post=8185"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/tags?post=8185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}