Sabuwar FDA Gargadi kan Viekira Pak da Technivie

Abubuwan tsaro sun damu da kulawar HCV

FDA ta kwanan nan ya ba da gargadi game da amfani da sababbin cutar kwantar da ƙwayoyin C a cikin marasa lafiya tare da ciwon hanta mai ƙyama ( FDA link ). Wadannan jami'in sune Viekira Pak (https://www.viekira.com/about-viekira) da Technivie (https://www.technivie.com) na Abbvie. Dukansu sune hanyoyin kwantar da hankali kuma duka sun haɗa da: paritaprevir, ombitasvir da ritonavir (Technivie); yayin da Viekira Pak ya ƙunshi dasabuvir.

Dukansu suna amfani da su tare da ribavirin. Wadannan jami'o'in sun kasance hanyoyin maganin cutar da ciwon hawan C 1 da 4 tare da maganin maganin magani fiye da 95%.

Duk da haka, tun lokacin da FDA ta amince, akwai lokuta da dama na yaduwar hanta a lokacin amfani da ƙwayoyi na wadannan mahadi. A cewar FDA ( FDA link ), "tun lokacin da aka amince da Viekira Pak a watan Disamba 2014 da Technivie a watan Yuli na 2015, a kalla 26 adadin duniya da aka gabatar zuwa FDA Kasuwancin Rahotanni (FAERS) sunyi la'akari da yiwuwar yiwuwar Viekira Pak ko Technivie. A mafi yawan lokuta, ciwon hanta ya faru a cikin makonni 1 zuwa 4 na farawa magani. Wasu daga cikin lokuta sun faru a marasa lafiya waɗanda aka haramta wa annan magunguna ko ba a bada shawarar su ba. "Bugu da ƙari," AbbVie, ya gano alamun rashin karfin zuciya da ciwon hanta a cikin marasa lafiya da masu ciwo masu hanta da ke dauke da wadannan maganin.

Wasu daga cikin abubuwan da suka faru sun haifar da haɓaka hanta ko mutuwa. Wadannan sakamako mai tsanani sun ruwaito mafi yawa a marasa lafiya dauke da Viekira Pak wanda ke da shaidar ci gaban cirrhosis ko da kafin fara magani tare da shi. "

FDA ta nuna cewa an ba da ƙarin bayani ga masu lafiya da masu kiwon lafiya a cikin labaran miyagun kwayoyi:

o Rashin tsoro

o rauni

o Rashin ci

o Nausea da vomiting

o Eyeshadow ko fata

o Yanki masu launin haske

Yana da muhimmanci a lura cewa wadannan lokuta sun faru ne kawai a cikin marasa lafiya da ciwon hanta. A halin yanzu babu wata hujja da ta nuna hatsari a mafi yawan marasa lafiya da cutar ciwon hauka C wadanda ke da rashin lafiya a cikin hanta. A ƙarshe, ainihin dalili da ingancin ciwo ya ci gaba da bincike.

Idan kuna shan ko dai Viekira Pak ko Technivie, ko kuna shirin fara ko dai farfadowa, ya kamata ku tattauna wannan batu tare da mai bada sabis na kiwon lafiya.