Izinketho ezintsha zokwelashwa zika-FDA ezitholakalayo zokuphefumula
I-Neurology iyinsimu eguquguqukayo esheshayo, okuthuthukiswa okusha okwenzeka ngaso sonke isikhathi. Emkhakheni wokufa kwesifo sokuphuza, imithi emisha yokulwa nesifo sofuba yamukelwa yi-Food and Drug Administration (FDA) eminyakeni emihlanu phakathi kuka-2012 no-2017.
Yenzani Le Mithi?
Iningi lala mithi lavunyelwa ukuxoshwa okuyingxenye, lokho kungukuqala kokuqala endaweni eyodwa yobuchopho kunokuba wonke umuntu ngesikhathi esisodwa.
Ngaphezu kwalokho, ezinye zezidakamizwa ezintsha zokulwa nokuthunjwa zisetshenziselwa ukuhlukunyezwa kwezinhlanzi zezingane, njengeLennox-Gastaut syndrome.
Amanye alawa mithi asetshenzisiwe ngaphandle kwelebula, okusho ukuthi odokotela bawachazela izinto ngaphandle kwalokho i-FDA eye yavumela inkampani ukuba ikhangise.
I-Trokendi XR (i-Topiramate)
Nakuba i-topiramate (i-Topamax) ivunyiwe yi-FDA ngo-1997 yokwelashwa kokuqala kokuthatha ingxenye, lena yiyona nguqulo ekhulisiwe, evunyelwe yi-FDA ngo-2013. I-Trokendi XR ingasetshenziswa yodwa iziguli ezineminyaka engu-10 noma ngaphezulu ezithintekayo noma ukuhlushwa kwe-tonic-clonic futhi njengokwelapha okwesikhashana kweziguli ezineminyaka engu-6 noma ngaphezulu abanokuhlukunyezwa okuyingxenye noma ye-tonic-clonic noma i-Lennox-Gastaut syndrome.
Imiphumela emibi ingabandakanya ukudideka, izinkinga zemizwelo, isizungu, ukukhathala, ukukhonsa noma ukushisa esikhumbeni, izinkinga zememori, ubunzima bokugxila, umkhuhlane, ukutheleleka, i-anorexia, ukulahlekelwa isisindo, ukulala, ukukhathazeka, izinkinga zokuqaphela, nokunciphisa imicabango nokunyakaza.
I-Trokendi XR i-capsule ethathwe kanye kuphela ngosuku.
Umshayeli (Brivaracetam)
Kuvunyelwe ngo-2016, i-brivaracetam ngokuyinhloko ihloselwe ukwelashwa okwesibili ukuphatha ukutholakala kokuqala okuyingxenye etholakalayo ekuthunjweni kweziguli ezineminyaka engu-16 noma ngaphezulu. Isebenza ngokuthinta iphrotheni okuthiwa i-synaptic vesicle 2A, esiza ukuyeka ukuwayeka.
Imiphumela emibi ingase ifake isicanucanu noma ukuhlanza, ukukhathala, isizungu, nokulala. I-Briviact ingenziwa njengephilisi, umjovo, noma isisombululo somlomo, konke kuthathwe kabili ngosuku.
I-Qudexy XR (i-Topiramate)
NjengesiTrokendi XR, i-Qudexy XR enye inguqulo yokukhululwa ephezulu eyenziwe ngo-2014. I-Qudexy XR iphinde ihlolwe ukuthi i-monotherapy yeziguli ezineminyaka engu-10 noma ngaphezulu ezinokuhlushwa okuyingxenye noma ye-tonic-clonic, kodwa ingasetshenziswa njengokwelashwa kwesibili iziguli ezineminyaka engu-2 nangaphezulu ezinomdlavuza oyingxenye noma we-tonic-clonic noma uLennox-Gastaut syndrome. I-Trokendi XR inqunyelwe iziguli ezineminyaka engu-6 nangaphezulu.
Imiphumela emibi ye-Qudexy XR ingabandakanya ukudideka, umkhuhlane, isizungu, ukulala, izinkinga zememori, ubunzima bokugxila, i-anorexia, ukutheleleka, izinkinga zemizwelo, ukwesaba, ukulahlekelwa isisindo, izinkinga zengqondo, ukuvutha noma ukuzwakala kwesigqila esikhumbeni, nokunciphisa imicabango nokunyakaza . Kuthathwa njenge-capsule kanye ngosuku.
I-Aptiom (i-Eslicarbazepine Acetate)
I-Aptiom, evunyelwe ngo-2013, i-Blocker yesiteshi se-sodium esinezivalo esetshenziswa njengendlela yokwelapha yesibili kweziguli ezinezinkinga zokuqala ezingenangxenye. Ukusebenza akucaci futhi akukaziwa uma kuphephile ukusebenzisa ezinganeni ezingaphansi kweminyaka engu-4.
Imiphumela emibi ingabandakanya ukukhanda ikhanda, isicashu, ukulala, ukukhathala, i-vertigo, ukuthuthumela, umbono ongeyena, isisindo sokuphuza, ukuhlanza, umbono ophindwe kabili, isizungu, nokunyakaza okungafani. I-Aptiom yi-tablet ethathwa kanye ngosuku.
I-Fycompa (i-Perampanel)
Njengabanye abaphikisana nesifo sofuba ngaphambi kwayo, i-perampanel inendlela entsha yesenzo, ihlose i-α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) ionotropic glutamate receptor. I-Perampanel ingasebenzisana nezidakamizwa ezifana ne-carbamazepine, i-oxcarbazepine, noma i-phenytoin futhi isetshenziselwa ukwelapha abantu abadala nabantwana abaneminyaka engu-12 noma ngaphezulu ngokubamba okuyingxenye, ukuhlukunyezwa okwesikhashana, noma ukutholwa kwe-tonic-clonic eyinhloko .
Imiphumela emibi ingabandakanya ukuzondeka, ukuzuza isisindo, ukukhathala, ukucasuka, ukuwa, izinkinga zokulinganisela, ukulala, ukunyakaza okungahambi kahle, kanye nokucabangela. I-Fycompa iyi-tablet ethathwa kanye ngosuku.
Izidakamizwa Ezintsha Ezilinganayo Ithemba Elisha
Njengamanje, cishe ingxenye yesithathu yeziguli ezinesifo sokuwa nesifo sokuphuza sezinqamuke ezingenakulawulwa kahle ngemithi yedwa. Ngokusungula izidakamizwa ezintsha ngamasu amasha, ithemba lethu ngelinye ilanga libe nezwe elinokuqothulwa mahhala.
> Imithombo:
> Franco V, iJalimane JA, i-Perucca E. Inselele ekuthuthukiseni izifo ezidakamizwa ezintsha ze-Antiepileptic. Ucwaningo lwezokwelapha . NgoJanuwari 2016; 103: 95-104.
> Ukubuka Isikhungo. FDA Izidakamizwa Ezivunyelwe I-Neurology. 2017.