Nthawi yomweyo FDA inachenjeza kuti ikhoza kubwereranso
Bungwe la United States la Food and Drug Administration linapereka chenjezo kumbuyo kwa 2008 kunena kuti panali umboni wina woyambirira Spiriva ukhoza kuwukitsa ngozi, komanso mwinamwake komanso chiopsezo cha matenda a mtima kapena imfa. Komabe, bungweli linayambiranso chenjezo mu 2010, kunena kuti umboniwu tsopano wasonyeza kuti Spiriva sanawonjezere ngozi.
Kodi nkhaniyi ndi iyi?
Umboni umene ulipo kuchokera kumayesero atsopano a zachipatala umasonyeza kuti Spiriva sawonjezera chiopsezo cha matenda, matenda a mtima, kapena imfa.
Spiriva imagwiritsidwa ntchito ku COPD kuti iwononge matenda a bronchospasms - njira zosayembekezereka m'mphepete mwa airways zomwe zimakupangitsa kuti zikhale zovuta kuti mupume. Mankhwalawa amatengedwa kamodzi tsiku ndi tsiku kudzera mu inhaler. Sichikufuna kuimitsa zizindikiro zadzidzidzi ngati "mankhwala opulumutsa" - mmalo mwake, muyenera kuchitenga nthawi zonse kuti akuthandizeni.
Chiyambi cha FDA chenjezo pa Spiriva, chomwe chinaperekedwa pa March 18, 2008, chinafunsa mafunso okhudza mankhwalawa chifukwa kufufuza kwa chiwerengero cha chitetezo choyambirira kuchokera ku mayesero 29 a Spiriva kunasonyeza kuti anthu ambiri omwe ali ndi COPD kutenga Spiriva anali ndi zikwapu kuposa anthu omwe amakhala ndi placebo osagwira ntchito.
Mwapadera, deta yoyamba ija inasonyeza kuti anthu asanu ndi atatu mwa anthu 1,000 aliwonse omwe amachititsa Spiriva anali ndi zilonda, poyerekeza ndi anthu asanu ndi mmodzi pa 1,000 omwe amatenga placebo. A FDA adanena kuti chidziwitsocho chinali choyambirira, koma adati akufuna kuchenjeza madokotala ndi odwala za izo. M'mbuyomu, bungweli likunenedwa kuti ndi lochedwa kwambiri kutulutsa machenjezo okhudza mankhwala osokoneza bongo.
Panthawi imodzimodziyo, a FDA adafunsa opanga Spiriva, kampani ya mankhwala Boehringer Ingelheim Pharmaceuticals, Inc., kuti abwererenso kukawerenganso nkhaniyi. Bungwe la federal linauzanso anthu omwe ali ndi COPD omwe adalamulidwa Spiriva kuti asaleke kumwa mankhwalawa, ndikukambirana za mavuto omwe ali nawo ndi madokotala awo.
Kuwonanso Kwambiri Kwambiri kwa Spiriva Sinawonetsere Vuto
Apolisi a FDA ndi anzawo ku Boehringer Ingelheim adasanthula zonse zomwe anasonkhanitsa ku Spiriva, a FDA pa Jan. 14, 2010 anachotsa chenjezo la chitetezo cha 2008 pa mankhwalawa:
"FDA yatsiriza kukambirana kwake ndikukhulupirira kuti deta yomwe ikupezeka sichigwirizana ndi mgwirizano pakati pa ntchito ya Spiriva HandiHaler komanso chiopsezo chowonjezereka cha zochitika zazikuluzikuluzi. FDA ikulangiza akatswiri azaumoyo kuti apitirize kupereka Spiriva HandiHaler monga momwe akulimbikitsira . "
Ndiye akatswiri azachipatala aganiza kuti chenjezo loyambirira la FDA pa Spiriva ndi kupweteka kwa msanga kunali msangamsanga, ndipo kufufuza mwatsatanetsatane kwa umboniwo kumasonyeza kuti mankhwala samapangitsa chiopsezo, matenda a mtima kapena imfa.
Zotsatira Zochepa za Spiriva
Spiriva, yomwe tsopano ikugulitsidwa m'zinenero ziwiri - Spiriva HandiHaler ndi Spiriva Respimat - ili ndi zotsatira zoyipa, zina zomwe zingakhale zovuta.
Zotsatira zofala kwambiri ndi Spiriva zimaphatikizapo matenda opuma opuma, wodwala pakamwa, ndi pakhosi. Chizunguliro kapena masomphenya olakwika akhoza kuchitika ndi Spiriva, zomwe zikutanthauza kuti muyenera kugwiritsa ntchito galimoto mosamala kapena ntchito.
Kuphatikizanso apo, Spiriva akhoza kuwonjezera kupsinjika m'maso mwanu, zomwe zimapangitsa kuti mukhale ovuta kwambiri a glaucoma , zomwe zingawononge masomphenya anu.
Ngati mumagwiritsa ntchito Spiriva ndikumva kupweteka kwa maso, maso osawona bwino kapena maso opukutira, ndipo ngati mutayang'ana ma halos pafupi ndi nyali, pitani kuchipatala mwamsanga.
Potsirizira pake, Spiriva angakuchititseni kuti mukhale ndi vuto loyambitsa mkodzo komanso kupweteka kwabwino. Ngati izi zikukuchitikirani, lekani kumwa mankhwala ndikuitana dokotala wanu.
Zotsatira:
Mchitidwe Wadziko Lonse Wofufuza, Kuteteza, ndi Kuteteza COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016.
US Food and Drug Administration Safety Alert. Tiotropium (wogulitsidwa monga Spiriva HandiHaler). Inatulutsidwa Jan. 14, 2010.