Zvokudya uye Drug Administration zvakabvumira kushandiswa kweprozac (fluoxetine) inopesana nemanzwiro sekurapa kwevana nevechiri kuyaruka makore manomwe kusvika kune gumi nemakore nemanzwiro ekuora mwoyo (chikuru chekuora mwoyo chirwere) kana kuvhara-kusagadzikana kwepfungwa (OCD) muna 2003.
Icho chiratidzo chinotevera chaitevera zvidzidzo zvakaratidza kuti Prozac yakanga yakachengeteka uye inoshanda kuvana vane matambudziko aya.
Asi nokuti mishonga haisi FDA yakagamuchirwa hairevi kuti haina kuchengeteka. Zvinongoreva kuti kambani yezvinodhaka inoita kuti mushonga wacho usashandise kune FDA kuti igamuchirwe. Prozac yakashandiswa zvakachengetedzeka kune vanhu vakuru kubva muna 1987.
Kubva-Kutora Zvinyorwa mukurapa
Mishonga yakawanda haisi FDA-inogamuchirwa kuti ishandiswe muvana asi ichiri kushandiswa 'off-label', zvinoreva kuti inoshandiswa kuvana vaduku kuti gore rakagamuchirwa kana mamwe mamiriro ezvinhu avasati vabvumirwe. Ichokwadi, maererano neAmerican Academy of Pediatrics, 'zvitatu zvechina zvemishonga yemishonga inowanikwa ikozvino muUnited States isina ruzivo rwekushandisa rubatsiro rwevana.'
Izvi hazvirevi kuti hazvisi nyore kushandisa mishonga iyi kunyange zvakadaro. Paanosarudza kushandisa mishonga 'off-label', chiremba anofanira kunge ari kuita sarudzo iyoyo 'zvichienderana nouchapupu hwakanaka hwezvesayenzi, nyanzvi yezvokurapa, kana kuparadzira mabhuku.' Hazvina kufanana nachiremba wako ari kuedza nemwana wako.
Kushandisa albuterol kubata vana vane asthma muenzaniso wakanaka wekuchengeteka 'off-label' kushandiswa kwechirwere. Kunyange zvazvo inowanzoshandiswa mucheche nevana vaduku, albuterol inongova FDA-inogamuchirwa kuti ishandiswe muvana vanopfuura makore maviri. Dzimwe dzakawanda zvepmma inhalers , zvakadai seDulera uye Advair ndeye FDA-inogamuchirwa kuti ishandiswe kuvana vanopfuura makore gumi nemaviri.
Saka sei mishonga iyi inoshandiswa kana isina FDA inogamuchirwa?
Mune mishonga yemishonga iyi yemahara, hapana mimwe mishonga yekushandisa uye iyi mishonga yakashandiswa zvakanyanya, inofungidzirwa kuti yakachengeteka uye zvidzidzo zvakaratidza kuti dzinoshanda. Uyezve, kusabata kana kudzivirira zviratidzo zvevana zvechirwere, hazvizogamuchirwi.
Izvozvowo ndezvekuora mwoyo uye nedambudziko rehutano hwepfungwa, izvo zvinowanzoshamwaridzana nevana uye pane dzimwe nguva zvinoda kurega-mavara mabhizimisi emishonga.
Tiri kuona mishonga yakawanda yeDAA inogamuchirwa kuvana vane matambudziko ehutano hwepfungwa, zvisinei, kusanganisira:
- Lexapro (escitalopram) vana (12 uye kupfuura) vane kuora mwoyo
- Luvox (fluvoxamine) vana (8-17) neOCD
- Zoloft (sertraline) vana (6-17) neOCD
- Lithium vana (12 uye kupfuura) vane bipolar
- Orap (pimozide) vana (12 nepamusoro) neTretret's disorder
- Risperdal (risperidone) autistic vana (5 nepamusoro)
Mamwe mishonga, seLithium, Zyprexa (olanzapine), Seroquel (quetiapine), uye Abilify (aripiprazole) uye anobvumirwa vana vane bipolar disorder kana schizophrenia.
Iwe unoziva sei kana mwana wako akambomira mishonga ye 'off-label'?
Iwe unogona kubvunza chiremba wako kana wemhizha, kana kungotarisa iyo pechere insert (PI) yakauya nemishonga.
MuPI, tsvaga chikamu chinzi 'Zviratidzo uye Kushandisa' kana kuti 'Kushandisa Kwemwana' uye ona kuti ndeapi makore akanyorwa. Yeuka kuti nekuda kwekuti mwana wako ari muduku kudarika nguva yakatarwa hazvirevi kuti mishonga haisi yakachengeteka uye haufaniri kumira pasina kutaura nachiremba wako.
Kudzoka kwe "Off-Label" Mishonga Inoshandisa
Imwe nyanzvi yakakura ndeyekuti dzimwe nguva vanachiremba vanofanirwa kuenzanisa kuyerwa kwekupa vana vaduku zvichienderana nematare anowanzoshandiswa kuvana vakuru nevakuru. Izvi zvingaita kuti vana vawane mushonga wakawandisa kana kuti muduku.
Chimwe chikamu ndechekuti kana chiremba wako asinganzwi akasununguka kushandisa zvinodhaka 'off-label' ipapo mwana wako angasave achiwana kurapa kwakanakisisa kunowanika.
Chiremba wako angangodaro achishandisa mishonga yakwegura nemimwe migumisiro kana mwana wako angave asina kugamuchira chero mishonga zvachose.
Chirongwa cheMishonga yeMishonga yeMishonga yakagadzwa neRDA kuedza nekuwana makambani ezvinodhaka kuedza mishonga yavo kuvana. The Best Pharmaceuticals for Children Act inoshandawo 'kuvandudza kuchengetedzwa nekubudirira kwemishonga yemishonga yevana.' Tariro, inotungamirira kune mamwe madhiragi ari kuongororwa uye anobvumirwa kuti ashandiswe muvana kuitira kuti varege kushandiswa kure-tekisi zvakare.
Sources:
American Academy of Pediatrics Policy Statement. Kurega-Kutarisa Kushandisa Zvinodhaka Muvana. Pediatrics. March 2014, VOLUME 133 / ISSUE 3