I-FDA yayisixwayisa ukuba iyakwazi, emva koko ibuyele emuva
I-US Food Administration and Drug Administration yanikezela isilumkiso ngo-2008 echaza ukuba kukho ubungqina bokuqala u-Spiriva inokuphakamisa umngcipheko we- stroke , kwaye mhlawumbi nayo ingozi yakho yokuhlaselwa intliziyo okanye ukufa. Nangona kunjalo, i-arhente yabuya isilumkiso ngo-2010, besithi ubungqina ngoku bubonise ukuba uSpiriva akazange akhulise loo mngcipheko.
Liliphi ibali apha?
Ubungqina obukhoyo obuvela kwiimvavanyo zonyango zakutshanje lubonisa ukuba i-Spiriva ayinyuli umngcipheko we-stroke, ukuhlaselwa yintliziyo okanye ukufa.
I-Spiriva isetyenziswe kwi- COPD ukunyanga i- bronchospasms - izithintelo ezizenzekelayo kwi-airways yakho eyenza kunzima ukuba uphefumle. Amachiza athatyathwa kanye ngosuku nge-inhaler. Akuhlosiwe ukuyeka iimpawu ezinokuzenzekelayo njengamayeza "okuhlangula" - endaweni yoko, kufuneka uthabathe rhoqo ukuze uncede.
Isilumkiso se-FDA sokuqala kwi-Spiriva, esikhutshwe ngoMatshi 18, 2008, saphakamisa imibuzo malunga neziyobisi kuba ukuhlalutya kwedatha yokukhusela kwangaphambili ukusuka kwiilingo ezingama-29 ezibandakanya i-Spiriva kuboniswe ukuba abantu abaninzi abaneCOPD bathatha i-Spiriva babenemivimbo kunokuba abantu bathathe indawo ye-placebo engasebenzi.
Ngokukodwa, loo datha yokuqala yabonisa ukuba abantu abasibhozo baphuma kwi-1,000 bethatha i-Spiriva babenemivimbo, xa kuthelekiswa nabantu abayisithandathu kuzo zonke i-1,000 ezithatha indawo ye-placebo. I-FDA yavuma ukuba ulwazi lwaluqala, kodwa luthi lufuna ukuphawula oogqirha kunye nezigulane malunga nalo. Kwixesha elidlulileyo, i-arhente isityholwa ukuba iphuphe kakhulu ukukhupha izilumkiso malunga neziyobisi.
Ngelo xesha, i-FDA yacela umenzi we-Spiriva, inkampani yezobisi i-Boehringer Ingelheim Pharmaceuticals, Inc., ukubuyela kwakhona iphinde iphinde ifunde kwakhona umba. Igosa lombuso lixelele nabantu abaneCOPD abaye bamiselwe uSpiriva ukuba bangayeki ukuthatha izidakamizwa, baze baxoxisane naluphi na ukukhathazeka ababenabo noogqirha babo.
Uhlaziyo oluthe ngqo olunzulu lweSpiriva aluzange lubonise inkinga
Emva kokuba ama-FDA namagosa aseBoehringer Ingelheim bahlalutye yonke idatha eqokelelwe kwi-Spiriva, i-FDA ngomhla kaJan. 14, 2010 wabuyela isilumkiso sokukhusela ngo-2008 kwiyeza:
"I-FDA sele iqedile ukuhlaziywa kwayo kwaye ikholelwa ukuba idatha ekhoyo ayixhaseli umbutho phakathi kokusetyenziswa kwe-Spiriva HandiHaler kunye nomngcipheko ophezulu walezi ziganeko ezibi kakhulu. I-FDA icebisa abaqeqeshi bezempilo ukuba baqhubeke becela uSpiriva HandiHaler njengoko kunconywe kwileyibhile yeziyobisi . "
Ngoko iingcali zonyango ziye zagqiba ukuba i-FDA isilumkiso sokuqala kwi-Spiriva kunye nokushaywa yintlungu yayingaphambi kwexesha, kwaye ukuhlaziywa ngokubanzi kwengqina kubonisa ukuba iyeza lingaziphakamisi umngcipheko, ukuhlaselwa yintliziyo okanye ukufa.
Iimpembelelo eziPhezulu zeSpiriva
I-Spiriva, ngoku ithengiswa ngeenguqulelo ezimbini-i-Spiriva HandiHaler kunye ne-Spiriva Respimat-inokubangela iziphumo ezibi, ezinye zazo ezinokuthi zibe zibi.
Iziphumo eziqhelekileyo ezichaphazelekayo kunye ne-Spiriva ziquka izifo eziphezulu zokuphefumula , umlomo owomileyo, kunye nomqala omzimba. Utywala okanye umbono obonakalayo ungenzeka kwakhona nge-Spiriva, oku kuthetha ukuba kufuneka usebenzise ukuqhubela umlenze okanye umatshini osebenzayo.
Ukongezelela, i-Spiriva inokunyusa uxinzelelo emehlweni akho, ekhokelela kwi- glaucoma esicacile- esecaleni , imeko engasongela umbono wakho.
Ukuba usebenzisa i-Spiriva kwaye ube neentlungu zamehlo, umbono ophazamisekileyo okanye amehlo avulekileyo, kwaye xa uqala ukubona iifayili ezijikelezayo, khaza ugqirha ugqirha.
Ekugqibeleni, i-Spiriva inokubangela ukuba ube nobunzima bokudlula umchamo kunye nokucima ubuhlungu. Ukuba oku kwenzeka kuwe, yeka ukuthabatha amayeza uze ubize ugqirha wakho.
Imithombo:
Isicwangciso seSigqeba soHlabathi, ukuLawula kunye nokuPhephelwa kweCOPD, i-Global Initiative ye-Lung Disease (GOLD).
ISaziso soKhuseleko lwezoKutya nokuLawulwa kweMilo. Tiotropium (kuthengiswa njengoSpiriva HandiHaler). Kukhishwe uJan 14, 2010.