Bhokisi Dema Manyevero Anoratidza Mungozi Dambudziko reMishonga Inodhaka.
Inyevero yebhokisi yebhokisi inowanikwa pane zita remishonga yemishonga yekurapa vatengi nevatapi vezvehutano pamusoro pekuchengetedzwa kwekuchengeteka, zvakadai semigumisiro yakaipa yakaipisisa kana ngozi dzinotyisa. Bhokisi rakasvibira bhenekeri ndiro rinonyanya kukosha mishonga inorayirwa neU.S. Food and Drug Administration (FDA). Chero nguva iyo mushure mokunge mishonga inogamuchirwa, FDA inogona kuda muiti kuti agadzire bhokisi rakasvibiswa rakanyorwa pane mishonga yepurasitiki.
Hurumende yeUnited States inoramba ichitarisa zvinogona kuipa zvakakomba zvemishonga. Isu tinogona kuziva zvirwere izvi zvakashata tichishandisa Dambudziko reNyaya yeChirongwa cheNyika uyewo neHhovisi yeSarveillance neEpidemiology, iyo inoongorora mishonga inotenderwa neDAA-inogamuchirwa pamusika.
Kazhinji kazhinji, nyevero yebhokisi nyevero inoshandiswa kuratidzira zvingava nemigumisiro yakaipa iyo inoda kuenzaniswa nekugona kubatsirwa; zvisinei, nyevero bhokisi dema rinogonawo kutsanangura kushandiswa kwezvinodhaka, kushandisa mirayiridzo uye kuongorora.
I-FDA inoda kuti vanogadzira zvinodhaka nemabhokisi ekutsvaga mabhokisi vanofanira kuisa ruzivo pamusoro pevamwe varwere vanobvumirwa nemishonga. Idzi ruzivo runowanikwa kuburikidza nemunhu wemishonga uye wekutengesa. Uyezve, kana iwe uine mibvunzo pamusoro pemishonga yemishonga, iri pfungwa yakanaka yekubvunza varimi vako. (VaPamesekese vanokosha uye vanochengeterwa zvigadziriswa zvezvirwere zvevarwere.)
Chazhinji munguva pfupi yapfuura, kuve nekuwedzera kwekuwedzera kwenhamba yebhokisi dema rekuchenesa rinodiwa neDFA. Pasinei nokuwedzera uku, zvisinei, pane huri kunetseka kuti vazhinji vanonyora havasi kunyatsoteerera nyevero idzi, vachiisa murwere kuchengeteka pangozi.
Vanachiremba, vanachiremba, chiremba vanobatsira, mukoti vadzidzisi, vanoita zvemishonga, vatengesi vezvinodhaka nevatengi (iwe) vanogona kutumira zvinyorwa pamusoro pemishonga paIndaneti paDefA MedWatch vachishandisa maitiro akaenzana.
Migumisiro inobva kune iyi mafomu inosanganisira Adverse Event Reporting System. Pakazosvika 1969 (zuva rawakatanga) uye 2010, zvinopfuura mamiriyoni mana mafomu akaendeswa kune FDA.
Black box warnings inogona kushandiswa kumunhu mumwe nemishonga kana makirasi akazara emishonga.
Uyewo Anozivikanwa Se :: nyevero nyevero, kunyeverwa kwebhokisi
Mienzaniso yemaziso emusiku nyevero:
- Dhiyabhorosi inoda kuti bhokisi risati rave rinorayira kune vose vanorwara nehutachiona nekuda kwehuwandu hwekuzviuraya nekuzvibata kune vechidiki vakura vari pakati pe18 ne24 panguva yekurapa kwokutanga - kazhinji yekutanga kusvika kumwedzi miviri yerapi. Iyi nyevero yebhokisi dema yakatanga kusikwa muna 2004 uye yakasimbiswa kuti igovere varwere vakwegura vasati vava nemakore makumi maviri nemana muna 2007.
- Angiotensin-receptor blockers (ARBs sai enalapril kana losartan) njodzi yemazuva ano kune fetus panguva yekubata. Nokudaro, mishonga iyi inopesana nehutachiona inofanira kudziviswa panguva yekuzvitakura. Zvakafanana neArbS, angiotensin-kuchinja enzyme inhibitors (ACE inhibitors kana kuti "statins") mishonga inopesana nemishonga inowedzerawo mungozi kumucheche unochera uye inofanira kudziviswa panguva yekuzvitakura.
- Aspirin inogona kukonzera Reye's syndrome muvana. Reye's syndrome isati isiri syndrome inokonzera kubatwa kwechiropa kana uropi. Kubudirira kweReye's syndrome muvana kwakabatanidzwa kuhutungamiri hweAspirin muvana vari kurarama kubva kuchirwere kana chirwere. Kutungamirirwa kweAspirin kuvana kunofanirwa kunyatsorongedzwa nechiremba. Uyezve, aspirin ine bhokisi rakawanda rakawanda rinokurudzira rinonyevera nezvemagetsi.
- Mishonga yemakemikari yemakemikari inonyevera nezvehuwandu hwehupombwe hwevakadzi vane makore makumi matatu nemakore kana kupfuura.
- Ibuprofen nedzimwe nhengo dzisiri dzisina kuvhiringidzika (NSAIDs) dzemauto masikati mabhokisi anonyevera achivabatanidza nekudzivirira kwepachiviri uye zvironda pamwe nekurova kwepfungwa (brain bleeds).
Kuparadzanisa Kufungidzira : Kana iwe kana munhu waunoda ari kutora mushonga nehurosi-bhokisi nyevero, zvinoita kuti iwe uzvizive nezvingangova nengozi dzemishonga yakadaro. Mukuwedzera pakutsvaga webhu, inzwa wakasununguka kubvunza chiremba wako, chiremba wemishonga kana imwe nyanzvi yehutano yehutano kune mazano nekutungamirirwa.
Sarudzo Sources
Eisendrath SJ, Cole SA, Christensen JF, Gutnick D, Cole M, Feldman MD. Kuora mwoyo. Muna: Feldman MD, Christensen JF, Satterfield JM. eds. Kurapa Kwokurapa: Murairo weKuita zveKliniki, 4e . New York, NY: McGraw-Hill; 2014.
Nyaya yakanzi "FDA Black Boxed Warnings: Nzira Yokushandisa Mishonga Yakachengeteka" yakanyorwa naNR O'Connor yakabudiswa muAmerican Family Physician muna 2010.