Ukulawulwa Kwezokudla Nezidakamizwa kuvumile ukusebenzisa i-Prozac (i-fluoxetine) ephikisana nokucindezeleka njengokwelashwa izingane nezingane ezineminyaka engu-7 kuya kwengu-17 ubudala nokucindezeleka (ukucindezeleka okukhulu kwesifo) noma ukucindezeleka okucindezelayo (OCD) ngo-2003.
Leso sibonakaliso esisha salandelwa izifundo ezabonisa ukuthi iPrazac iphephile futhi iphumelele kubantwana abanalesi sifo.
Kodwa ngenxa nje yokuthi umuthi awuvunyelwe i-FDA akusho ukuthi akuphephile. Kusho nje ukuthi inkampani yezidakamizwa ezenza isidakamizwa asizange sisebenzise ku-FDA ukuze kuvunywe. I-Prozac yayisetshenziswe ngokuphepha kubantu abadala kusukela ngo-1987.
I-Off-Label Ukuchaza Ngokwezinsana
Izidakamizwa eziningi azivunyelwe i-FDA ukuze zisetshenziswe ezinganeni kepha zisasetshenziswa 'ngaphandle kwelebula', okusho ukuthi zisetshenziselwa izingane ezincane ukuthi iminyaka yobudala noma ezinye izimo ezingavunyelwe okwamanje. Eqinisweni, ngokusho kwe-American Academy of Pediatrics, 'izidakamizwa ezintathu zemithi edayiswayo manje e-United States ayinalo ulwazi lokusebenzisa izingane.'
Lokhu akusho ukuthi akuphephile ukusebenzisa lemithi noma kunjalo. Uma unquma ukusebenzisa imithi 'off-ilebula', udokotela kufanele enze leso sinqumo 'ngokusekelwe ubufakazi obuhlakani besayensi, isazi sezokwelapha sezokwelapha, noma izincwadi ezishicilelwe.' Akufani nodokotela wakho ohlola ingane yakho.
Ukusetshenziswa kwe-albuterol ukuphatha izingane ezine-asthma yisibonelo esihle sokusetshenziswa kwe-'ex-label 'ephephile kwesidakamizwa. Nakuba ngokuvamile esetshenziselwa izingane nezinsana, i-albuterol i-FDA kuphela evunyelwe ukusetshenziswa ezinganeni ezingaphezu kweminyaka emibili ubudala. Ezinye eziningi ze- asthma inhalers , njengeDulera ne-Advair yi-FDA kuphela evunyelwe ukusetshenziswa ezinganeni ezingaphezu kweminyaka engu-12.
Ngakho kungani le mithi isetshenzisiwe uma ingavunyelwe i-FDA?
Endabeni yale mithi ye-asthma, ayikho enye imithi okufanele isetshenziswe futhi le mithi isetshenzisiwe kakhulu, bacatshangwa ukuthi iphephile futhi izifundo zibonise ukuthi ziyasebenza. Futhi okunye, hhayi ukuphatha noma ukuvimbela izimpawu ze- asthma zezingane, ngeke kwamukeleke.
Kuyafana nokucindezeleka kanye nezinye izinkinga zempilo yengqondo, okuyinto ngeshwa evamile ezinganeni futhi ngezinye izikhathi zidinga izidakamizwa ezibhalwe phansi.
Sibona imithi eminingi evunyelwe i-FDA yabantwana abanezinkinga zempilo yengqondo, noma kunjalo, kubandakanya:
- I-Lexapro (escitalopram) izingane (12 nangaphezulu) ngokucindezeleka
- I-Luvox (fluvoxamine) izingane (8-17) ne-OCD
- Izingane Zoloft (sertraline) (6-17) ne-OCD
- I-lithium kids (12 nangaphezulu) ene-bipolar
- I-Orap (pimozide) izingane (12 nangaphezulu) ezinezinkinga zikaTourette
- I-Risperdal (risperidone) izingane ezizimele (5 nangaphezulu)
Ezinye imithi, njengeLithium, iZyprexa (olanzapine), i-Seroquel (quetiapine), ne-Abilify (i-aripiprazole) futhi ivunyiwe izingane ezinezinkinga zokucindezeleka kwe-bipolar noma i-schizophrenia.
Uyazi kanjani ukuthi ngabe ingane yakho inqunywe imithi 'ye-off' ilebula?
Ungacela udokotela wakho noma ummithi, noma mane uhlole i-package ye-package (PI) efike nemithi.
Ku-PI, bheka isigaba esibizwa ngokuthi 'Izibonakaliso nokusetshenziswa' noma 'Ukusetshenziswa kwezingane' bese ubona ukuthi yimiphi iminyaka edalwe. Khumbula ukuthi ngenxa yokuthi ingane yakho isencane kunalesi sihlonzi asisho ukuthi imithi ayiphephile futhi akufanele uyivimbe ngaphandle kokukhuluma nodokotela wakho.
Ukuphuluka Kwe-'Top-Off 'Imithi Sebenzisa
Esinye sezimpikiswano ezinkulu ukuthi odokotela ngezinye izikhathi kufanele balinganise umthamo wokunikeza izingane ezincane ngokusekelwe kwesilinganiso esivame ukusetshenziswa izingane kanye nabantu abadala. Lokhu kungaholela ezinganeni ukuthola umuthi omningi noma omncane kakhulu.
Enye iphuzu ukuthi uma udokotela wakho engazizwa ekhululekile ukusebenzisa izidakamizwa 'off-ilebula' kungenzeka ingane yakho ingase ingatholi ukwelashwa okungcono kakhulu etholakalayo.
Udokotela wakho angase asebenzise imithi endala enezinye imiphumela emibi noma ingane yakho ingase ingatholi noma imuphi imithi.
I-Dedicated Drug Rule yasungulwa yi-FDA ukuzama ukuthola izinkampani zemithi ukuhlola izidakamizwa zabo ezinganeni. Umthetho we-Best Pharmaceuticals for Children Act usebenza futhi 'ekuthuthukiseni ukuphepha nokusebenza kwezidakamizwa zezingane.' Sethemba ukuthi zizoholela ezidakamizweni eziningi zihlolwe futhi zivunyelwe ukusetshenziswa ezinganeni ukuze zingasadingeki zisetshenziswe-ilebula.
Imithombo:
Isitatimende Somgomo Wezemfundo yase-American Academy. Ukukhishwa kwelebuli Ukusetshenziswa kwezidakamizwa ezinganeni. Izingane zokwelapha. Mashi 2014, VOLUME 133 / ISSUE 3