Chenjezo latsopano la FDA pa Viekira Pak ndi Technivie

Chitetezo cha HCV mankhwala

A FDA atangomaliza kupereka chidziwitso cha chitetezo pogwiritsa ntchito mankhwala atsopano a chiwindi a hepatitis C kwa odwala omwe ali ndi matenda aakulu a chiwindi ( FDA link ). Omwe amavomerezedwa ndi Viekira Pak (https://www.viekira.com/about-viekira) ndi Technivie (https://www.technivie.com) ndi Abbvie. Zonsezi ndizo mankhwala ophatikizana ndipo onsewa ali ndi: paritaprevir, ombitasvir ndi ritonavir (Technivie); pamene Viekira Pak imakhala ndi dasabuvir.

Zonsezi zimagwiritsidwanso ntchito pamodzi ndi ribavirin. Mankhwalawa akhala mankhwala othandiza kwambiri pa matenda a hepatitis C omwe amakhalapo 1 ndi 4 ndi mankhwala opatsirana ambiri kuposa 95%.

Komabe, kuyambira nthawi ya FDA yovomerezeka, pakhala pali chiwerengero cha chiwerengero cha chiwindi cha chiwindi pamagwiritsa ntchito mankhwalawa. Malinga ndi FDA ( FDA link ), "popeza kuvomereza Viekira Pak mu December 2014 ndi Technivie mu Julayi 2015, milandu 26 padziko lonse yaperekedwa ku FDA Adverse Event Reporting System (FAERS) inkaganiziridwa kukhala mwina kapena yogwirizana ndi Viekira Pak kapena Technivie. Pazochitika zambiri, kuvulala kwa chiwindi kunachitika pakadutsa masabata 1 mpaka 4 akuyamba mankhwala. Ena mwa milanduyi anachitika kwa odwala omwe mankhwalawa anali otsutsana kapena osavomerezedwa. "Kuonjezera apo," AbbVie, anapeza milandu yowonongeka ndi chiwindi ndi chiwindi mwa odwala okhala ndi chiwindi cha chiwindi chomwe anali kutenga mankhwalawa.

Zina mwa zochitikazi zinapangitsa kuikidwa kwa chiwindi kapena kufa. Zotsatira zazikuluzi zidawoneka makamaka mwa odwala omwe amatenga Viekira Pak omwe anali ndi umboni wa chiwopsezo chachikulu ngakhale asanayambe kumwa mankhwala. "

A FDA awonetsa kuti zidziwitso zina zowonjezera ziyenera kuperekedwa kwa odwala komanso odwala payekha la mankhwala:

o Kutopa

o Kufooka

o Kutaya njala

o Kusuta ndi kusanza

o Maso kapena khungu loyera

o Zojambula zowala

Ndikofunika kuzindikira kuti milanduyi inkachitika makamaka mwa odwala omwe ali ndi matenda akuluakulu a chiwindi. Pakadali pano palibe umboni wosonyeza ngozi kwa odwala ambiri omwe ali ndi chiwindi cha C omwe ali ndi matenda a chiwindi ochepa mpaka ochepa. Potsirizira pake, chifukwa chenichenicho ndi njira ya chovulalacho zikupitirira kufufuza.

Ngati mutenga Viekira Pak kapena Technivie, kapena mukukonzekera kuyamba mankhwala, muyenera kukambirana nkhaniyi ndi wothandizira zaumoyo wanu.