I-Food and Drug Administration ivume ukusetyenziswa kweprozac (i-fluoxetine) engathinteliyoyo njengokonyango kubantwana nakwishumi eli-10 ubudala ubudala kunye nokudandatheka (ingxaki enkulu yokudakumba) okanye ingxaki yokunyanzela (OCD) ngo-2003.
Esi sibonakaliso esitsha salandelwa izifundo ezabonisa ukuba iPrac ikhuselekile kwaye isebenza kubantwana abanezi ngxaki.
Kodwa ngenxa yokuba iyeza lingavunyelwanga yi-FDA alithethi ukuba alukhuselekile. Kusho nje ukuba inkampani yeziyobisi eyenza ukuba isiza lingazange sisebenzise kwi-FDA ukuze kuvunywe. Iprozac yayisetyenziswe ngokukhuselekileyo kubantu abadala ukususela ngo-1987.
Ukunikezelwa kweTyhulwa kwiTediatrics
Amachiza amaninzi awavunyelwanga yi-FDA ukuba asetyenziswe kubantwana kodwa isetyenzisiwe 'ngaphandle kwelebula', oku kuthetha ukuba zisetyenziselwa abantwana abaselula ukuba iminyaka yobudala okanye ezinye iimeko ezingagunyaziwe. Enyanisweni, ngokwe-American Academy of Pediatrics, 'ezintathu zeesine zemithi yonyango ekuthengiswayo eUnited States ayinakho ulwazi lokusetyenziswa kwabantwana.
Oku akuthethi ukuba akukho khuselekile ukusebenzisa la mayeza. Xa ugqiba ukusetyenziswa kweyeza 'kwilebuli', ugqirha kufuneka enze eso sigqibo 'ngokusekelwe kubungqina bobunzululwazi obufanelekileyo, ugqirha lwezonyango, okanye uncwadi olupapashwe.' Akufani nogqirha wakho ozama umntanakho.
Ukusetyenziswa kwe-albuterol ukuphatha abantwana abane-asthma ngumzekelo omhle wokusetyenziswa kwekhutshana ekhuselekileyo. Nangona isetyenziswa ngokuqhelekileyo kwiintsana nabantwana, i-albuterol kuphela i-FDA-evunyelwe ukusetyenziswa kwabantwana abangaphezu kweminyaka emi-2 ubudala. Ezinye ezininzi ze- asthma inhalers , ezifana neDulera kunye ne-Advair zivunyelwe kuphela yi-FDA ukuba zisetyenziswe kwabantwana abangaphezu kweminyaka eyi-12 ubudala.
Ngoko kutheni le miyeza esetyenzisiweyo ukuba ayifumanekanga i-FDA?
Kwimeko yale miyeza ye-asthma, ayikho enye imichiza yokusetyenziswa kwaye la mayeza asetyenziswe kakhulu, acinga ukuba aphephile kwaye uphando lubonise ukuba lusebenza. Kwaye, enye indlela, ukunyanga okanye ukukhusela iimpawu ze- asthma zezingane, ayiyi kwamkeleka.
Kuyafana nokuxinezeleka kunye nezinye iingxaki zempilo yengqondo, ezithe ngenye indlela eziqhelekileyo kubantwana kwaye ngamanye amaxesha zifuna izidakamizwa zonyango ze-label.
Sibona amanye amayeza avunyelwe yi-FDA kubantwana abaneengxaki zempilo yengqondo, nangona kunjalo, kuquka:
- Lexapro (escitalopram) abantwana (12 nangaphezulu) kunye nokudakumba
- I-Luvox (i-fluvoxamine) abantwana (8-17) kunye ne-OCD
- Zoloft (sertraline) abantwana (6-17) kunye ne-OCD
- I-Lithium (12 nangaphezulu) ene-bipolar
- I-Orap (i-pimozide) abantwana (12 nangaphezulu) kunye neengxaki zikaTourette
- Iingozi ze-risperidone (risperidone) ze-autistic (5 nangaphezulu)
Amanye amayeza, njengeLithium, iZyprexa (olanzapine), uSeroquel (quetiapine), kunye ne-Abilify (aripiprazole) kwaye avunyelwe abantwana abane-bipolar disorder okanye i-schizophrenia.
Uyazi njani ukuba umntwana wakho umiselwe 'unyango'?
Unokubuza ugqirha wakho okanye umseli-mveliso, okanye khangela nje i-package ye-package (PI) efike ngeyeza.
Kwi-PI, khangela isigaba esibizwa ngokuthi 'Imiqondiso kunye nokusetyenziswa' okanye 'Ukusetyenziswa kwezilwanyana' kwaye ubone ukuba yeyiphi iminyaka edibeneyo. Khumbula ukuba ngenxa yokuba umntwana wakho usemncinci kunelo ludwelwe aluthetha ukuba amayeza akhuselekile kwaye akufanele uyeke ngaphandle kokuthetha nodokotela wakho.
Ukuhlaselwa kwe-'Town Label 'Usetyenziso lweMithi
Enye into ebalulekileyo kukuba oogqirha ngamanye amaxesha kufuneka baqikelele umyinge wokunika abantwana abancinci ngokusekelwe kumlinganiselo oqhelekileyo owenzelwe abantwana abadala kunye nabantu abadala. Oku kunokukhokelela kubantwana abafumana unyango oluninzi okanye oluncinane.
Enye ingcambu kukuba ukuba ugqirha wakho akayi kukhulula ukusebenzisa izidakamizwa 'ngaphandle kwelebuli' ngoko umntwana wakho akanako ukufumana unyango olungcono.
Ugqirha wakho unokusebenzisa iyeza elidala kunye nemiphumo engaphezulu okanye umntwana wakho akanako ukufumana nayiphi na imithi.
Umthetho weDermatric Drug Rule uqaliswe yi-FDA ukuzama nokufumana iinkampani zamachiza ukuvavanya iziyobisi zabo kubantwana. UMthetho oPhezulu weMveliso weeMveliso woLwabiwo lwaBantwana uphinde usebenze 'ukuphucula ukhuseleko kunye nokusebenza kweemveliso zonyango kubantwana.' Ngethemba, baya kubakho kwiziyobisi ezininzi ezihlolwe kwaye zivunyiwe ukuba zisebenzise kubantwana ukuze zingasetyenzisiwe ngaphandle kwelebula.
Imithombo:
I-American Academy ye-Pediatrics Policy Statement. I-Label engekhoyo Ukusetyenziswa kwezidakamizwa kubantwana. Pediatrics. Matshi 2014, INQUBO 133 / ISIHLOKO 3