I-FDA yaxwayisa ukuthi kungenzeka, bese ibuya emuva
I-US Food Administration and Drug Administration yanikeza isixwayiso emuva ngo-2008 esho ukuthi kwakukhona ubufakazi bokuqala uSpiriva engayenza ingozi yokushaya isifo , futhi mhlawumbe nayo ingozi yokuhlaselwa yinhliziyo noma ukufa. Kodwa-ke, i-ejensi yabuya isixwayiso ngo-2010, ethi ubufakazi manje bakhombise ukuthi uSpiriva akazange akhulise lezo zingozi.
Iyini indaba lapha?
Ubufakazi obukhona obuvela ezivivinyweni zakamuva ezitholakala emtholampilo kubonisa ukuthi uSpiriva akwandise ingozi yokushaya isifo, ukushaya inhliziyo, noma ukufa.
I-Spiriva isetshenziselwa i- COPD ukuphatha ama- bronchospasms - ukuphazamiseka okungazelelwe ku-airways okwenza kube nzima kuwe ukuphefumula. Umuthi uthathwa kanye nsuku zonke ngokusebenzisa i-inhaler. Akuhlosiwe ukuyeka izimpawu ezizenzekelayo njengokuthi "imithi yokuhlenga" - esikhundleni salokho, kufanele uyithathe njalo ukuze ikusize.
Isixwayiso sokuqala se-FDA ku-Spiriva, esikhishwe ngoMashi 18, 2008, sakhuphula imibuzo mayelana nalesi sidakamizwa ngoba ukuhlaziywa kwedatha yokuphepha kwangaphambili kusukela ekuhlolweni kwemitholampilo engu-29 okubandakanya uSpiriva kuboniswe ukuthi abantu abaningi abaneCOPD bathatha uSpiriva babenemivimbo kunabantu abahlala endaweni engasebenzi.
Ngokuqondile, lolo datha lokuqala lubonise ukuthi abantu abayisishiyagalombili kwabayishumi ku-1,000 abaphatha i-Spiriva babenemivimbo, uma kuqhathaniswa nabantu abayisithupha kuzo zonke izinkulungwane eziba ngu-placebo. I-FDA yavuma ukuthi lolu lwazi lwaluyisandulela, kodwa luthi lufuna ukuxwayisa odokotela neziguli ngakho. Esikhathini esedlule, i-ejensi ibikwa ukuthi iyashesha kakhulu ukukhipha izixwayiso zokuphepha mayelana nezidakamizwa.
Ngesikhathi esifanayo, i-FDA yabuza umkhiqizi we-Spiriva, inkampani yezokwelapha uBoehringer Ingelheim Pharmaceuticals, Inc., ukubuyela emuva futhi afunde futhi. I-federal agency nayo yatshela abantu abaneCOPD ababemiswe uSpiriva ukuthi bangayishiyi ukuthatha izidakamizwa, futhi baxoxisane nokukhathazeka ababenakho nodokotela babo.
Ukubuyekeza Okuningiliziwe Okuningiliziwe kwe-Spiriva Akuzange Kubonise Inkinga
Lapho izikhulu ze-FDA kanye nabalingani babo eBoehringer Ingelheim bebukeze yonke idatha eqoqwe ku-Spiriva, i-FDA ngoJan 14, 2010 yaphinda ixwayise ngokuphepha ngo-2008 ngemithi:
"I-FDA isiqedile ukubuyekezwa kwayo futhi ikholelwa ukuthi idatha ekhona ayisekeli ubudlelwane phakathi kokusetshenziswa kukaSpiriva HandiHaler nenengozi eyengeziwe yalezi zenzakalo ezimbi kakhulu. I-FDA iyala abaqeqeshiwe bezempilo ukuthi baqhubeke nokumisela uSpiriva HandiHaler njengoba kunconywa kule ilebula lezidakamizwa . "
Ngakho-ke ochwepheshe bezokwelapha baye baphetha ngokuthi isixwayiso sokuqala se-FDA ku-Spiriva nesifo sokushaya isisu sasingakapheli, futhi ukubuyekezwa okuningiliziwe kobufakazi kubonisa ukuthi imithi ayiphakamise ingozi yokushaya isifo, isifo senhliziyo noma ukufa.
Imiphumela emibi ye-Spiriva
I-Spiriva, manje edayiswa ngezihumusho ezimbili - i-Spiriva HandiHaler ne-Spiriva Respimat-inayo amandla okuba nemiphumela emibi, okunye okungase ibe yingozi.
Imiphumela emibi kakhulu ehambisana ne-Spiriva ihlanganisa ukutheleleka okuphezulu kokuphefumula , umlomo omile, nomsindo. Ukuzivocavoca noma umbono obonakele kungase kwenzeke no-Spiriva, okusho ukuthi udinga ukusebenzisa ukushayela okuqapha noma imishini yokusebenza.
Ngaphezu kwalokho, i-Spiriva ingakhuphula ingcindezi emehlweni akho, eholela ku- glaucoma elincane elincane, isimo esingasongela umbono wakho.
Uma usebenzisa i-Spiriva futhi unayo ubuhlungu beso, umbono obonakalayo noma amehlo abomvu, futhi uma uqala ukubona ama-halos azungeze izibani, shayela udokotela wakho ngokushesha.
Okokugcina, i-Spiriva ingabangela ukuba ube nobunzima bokudlula umchamo nokuvuthwa okubuhlungu. Uma lokhu kwenzeka kuwe, yeka ukuthatha imithi bese ubiza udokotela wakho.
Imithombo:
Isu Lomhlaba Wonke Lokuthola Ukuxilongwa, Ukuphathwa Nokuvimbela I-COPD, Global Initiative for Chronic Acstructive Lung Disease (GOLD) 2016.
Isixwayiso Sokuphepha Ukulawulwa Kwezokudla Ne-Drug US. I-Tiotropium (ithengiswe njenge-Spiriva HandiHaler). Ikhishwe uJan 14, 2010.