Bhokisi rebhokisi dema ndiyo inyevero yakasimba yakabudiswa neU.S. Food and Drug Administration (FDA) kuti mishonga inogona kutakura uye ichiripo pamusika muUnited States.
Inyevero yebhokisi bhenesi inowanikwa pane zita remishonga yemishonga yekukurudzira iwe neupi wako wehutano hwehutano pamusoro pezvinhu zvakakosha zvinetso zvekuchengetedza, zvakadai semigumisiro yakakomba yakaipisisa kana njodzi dzinopisa upenyu.
Bhokisi rebhokisi dema, iro rinozivikanwa se "black label warning" kana "boxed warning," inonzi zita remusiya wakanga wakakomberedza mutsara wehevero inowanikwa pane papeti, mavara, uye mamwe mabhuku anotsanangura mishonga (somuenzaniso , magazine advertising).
Apo FDA inoda imwe
Iyo FDA inoda nyevero yebhokisi dema kune imwe yemamiriro ezvinhu anotevera:
- Mishonga inogona kukonzera kuipa kwakanyanya kusingadi (zvakadai sekuuraya, kutyisidzira upenyu kana kugadzirisa zvachose kusagadzikana kwakaipisisa) zvichienzanisa nekugona kubatsirwa nemishonga. Zvichienderana nehutano hwako, iwe nechiremba wako unoda kusarudza kana kubatsirwa kwekutora mishonga kunokosha.
- Chiito chakakomba chakaipa chinogona kudziviswa, kuderedzwa kazhinji, kana kuderedzwa zvakasimba nekushandiswa kwakakodzera kwechirwere. Somuenzaniso, mishonga inogona kunge yakachengeteka kushandiswa kune vanhu vakuru, asi kwete muvana. Kana kuti, mishonga yacho inogona kunge yakachengeteka kushandiswa mune vakadzi vakuru vasiri mimba.
Mashoko Anonyanya Kudiwa
I-FDA inoda kunyeverwa kwebhokisi kuti ipe pfupiso yakajeka yemigumisiro yakaipa uye njodzi dzinobatanidza nokutora mishonga. Iwe nechiremba wako unoda kuziva ruzivo urwu paunosarudza kutanga mishonga kana kana iwe uchifanira kushandura kune imwe mishonga zvachose.
Kunzwisisa migumisiro yakaipa kuchakubatsira iwe kuita sarudzo yakanaka.
Mienzaniso yekunyevera
Izvi zvinotevera mienzaniso yehusiku bhenekeri nyevero dzave dzichitarisirwa kune mamwe maitiro anowanzoshandiswa:
Fluoroquinolone Antibiotics
Maererano neDFA, vanhu vanotora fluoroquinolone mishonga inorwisa mabhakitiriya vane ngozi inowedzera ye tendinitis uye tendon kuparara, kukuvara kwakakomba kunogona kukonzera kusagadzikana kwekusingaperi. Dhiyabhorosi ye FDA inosanganisira Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin) nemimwe mishonga ine fluoroquinolone. (Yambiro yakabudiswa muna July 2008.)
Diabetes Mishonga
Maererano neDFA, vanhu vane chirwere cheshuga vachitora Avandia (rosiglitazone) vane ngozi yakawanda yekushaya mwoyo kana kukuvara kwemoyo kana vakatova nechirwere chemwoyo kana vari pangozi yekutambudzika kwepfungwa. (Yambiro yakabudiswa muna November 2007.)
Kunyanya Kuora Mishonga
Maererano neDFA, mishonga yose inopesana nemishonga inowedzera ngozi yekuzviuraya nekuzvibata, inozivikanwa sekuzviuraya, kune vechidiki vakura vane makore 18 kusvika ku24 panguva yekurapa kwokutanga (inowanzotanga kusvika kumwedzi miviri). Dhiyabhorosi ye FDA inosanganisira Zoloft (sertraline), Paxil (paroxetine), Lexapro (escitalopram), nemamwe mishonga inodzvinyirira.
(Yambiro yakabudiswa muna May 2007.)
Chii Chinotaridzika?
Inotevera inotevera kubva murairi yezvinyorwa zveZoloft muenzaniso webhokisi rekutsva bhokisi.
Kuzviuraya muvana nevana vaduku
Zvinodhaka kuzvidzora zvinowedzera mukana wekuzviuraya uye kuzvibata (kuzviuraya) mune zvidzidzo zvenguva pfupi kuvana nevechiri kuyaruka vane Major Depressive Disorder (MDD) nezvimwe zvirwere zvepfungwa. Ani naani anofungisisa kushandiswa kweZoloft kana chero umwe munhu anodzvinyirira mumwana kana mwana ari kuyaruka anofanira kuenzanisa dambudziko iri nechechirwere. Varwere vanotanga kurapwa vanofanira kuongororwa zvakanyanya nokuda kwekuchirapa kuchipatara, kuzviuraya, kana kushanduka kusingaoneki mufambiro. Mhuri uye vatarisiri vanofanira kupiwa mazano ekudiwa kwekucherechedza zvakaperera uye kukurukurirana nemunyora. Zoloft haibvumirwi kushandiswa mune varwere vevana kunze kwevatano vane obsessive-compulsive disorder (OCD).
Opioid Mishonga
Muna 2013, FDA yakabudisa chirevo chichitaura nezvekuchengetedzwa kweklasi-yakawanda pakuratidzira kushandiswa kwese-yakasunungurwa uye kwenguva refu (ER / LA) maawareji opioid. Chimwe chikamu chekuchinja uku chinosanganisira mabhokisi anonyeverwa anoratidza njodzi yeapioid zvisina kunaka, kushungurudzwa, kuvimba. kunyanya kudarika uye rufu kunyange paanorayirwa maitiro.
Muna 2016, FDA yakabudisa maitiro akafanana ekupa mazita uye nyevero yemishonga inosunungurwa pakarepo-opioid.
Muchikamu chese, shanduko iyi inopindurwa zvakananga kune denda reopioid iri kuunza United States. Uyezve, iyo FDA inoda kusimbisa kuti mishonga yeopioid inofanira kushandiswa chete mumatambudziko ekurwadziwa kwakanyanya asingagoni kutarisirwa chero imwe nzira. Mune mamwe mazwi, maopioid imishonga inokuvadza kana isingashandisi zvine njere pasi pekutarisa kwechiremba pedyo.
Mishonga Inotungamirira
Pamwe chete nehusiku bhokisi rekutsvaira, FDA inodawo kambani yekushandisa zvinodhaka kugadzira mutungamiri wemishonga ine ruzivo rwevatengi kuti vangashandisa sei zvakachengeteka mishonga chaiyo. Aya mazano ane mashoko eDAA-akagamuchirwa anogona kukubatsira kuti usapinda chiitiko chakakomba chakaipa.
Aya mazano anotarisirwa kuti apiwe newadhirosi yako panguva iyo iwe une mishonga yako yakazara. Aya mazano anowanikawo paIndaneti kubva kumakambani ezvinodhaka uye kubva kuDFA. Somuenzaniso, mutungamiri wemishonga weAvandia (rosiglitazone) unowanikwa kubva kuna GlaxoSmithKline, muumbi weAvandia, uye kubva kuDefA Center yeDrug Evaluation nekutsvakurudza.
Kana iwe unonetseka kuti mushonga wako une nyevero yebhokisi nyevero, bvunza mhizha wako uye, kana uripo, uwane kopi yakadhindwa yemutungamiri wemishonga.
Zvimwe Zvinyorwa
Dhip Information Information Centre yeKansas University Medical Centre inochengetedza mutsara wepakombiyuta yemishonga yose ine nyevero yebhokisi inonyeverwa. Mishonga inorongwa nemazita evanhu. Kana uri kutora zita rechirwere chemishonga , kuchenjera kutarisa zita rechiito .
> Sources
> FDA News Release. FDA inoparidzira nyevero dzakagadziriswa dzemishonga inosuruvarisa yeopioid yakasununguka inobatanidza nengozi dzokushandisa zvisina kunaka, kushungurudzwa, kupindwa muropa, kuderedza, uye kufa.
> FDA News Release. FDA inozivisa kuchengetedzwa kwekuchengetedzwa kwekuchengetedzwa kwekuchengetedza uye postmarket zvidzidzo zvidzidzo zvekubudiswa kwekuwedzerwa kwekare uye maawareji anopera maawa.