Isilumkiso seNtsundu esimnyama sibonisa iingozi zokusetyenziswa kwezidakamizwa.
Isilumkiso sebhokisi emnyama sibonakala kwilebula yonyango lonyango ukuphawula abathengi kunye nababoneleli ngezempilo malunga nokukhathazeka kokhuseleko, njengemiphumo emibi okanye engozi yokuphila. Isixwayiso sebhokisi ebomnyama sisilumkiso esisinyanisekileyo sonyango esifunwa yi-US Food and Drug Administration (FDA). Naliphi na ixesha emva kokuba izidakamizwa zivunyiwe, i-FDA inokufuna umenzi ukuba enze isilumkiso sebhokisi emnyama esibhalwe kwiipakethe zonyango.
Urhulumente waseUnited States uqhubeka ngokubeka esweni isiphumo esibi kakhulu seziyobisi. Siyakwazi ukuchonga le miphumo emibi isebenzisa iNkqubo yokuBika ingxelo yeNgehlakalo kunye neHhovisi loPhononongo kunye ne-Epidemiology, ehlola i-MEDA-approved approved-market-market.
Ngokuqhelekileyo, izilumkiso zebhokisi ezimnyama zisetyenziselwa ukubonisa iziphumo ezinobungozi ezifunekayo ukuba zifaniswe neenzuzo ezinokwenzeka; Nangona kunjalo, izixwayiso zebhokisi ezimnyama zingabonisa iinkcukacha ezinokubambisana kwezidakamizwa, imiyalelo yokulandelela kunye nokubeka iliso.
I-FDA idinga ukuba abavelisi beziyobisi ngeebhokisi ze-black boxedings should include information about which patients are candidates for the drug. Olu lwazi lufumaneka kwikhomistiki yakho nakwi-intanethi. Ngaphezu koko, ukuba unemibuzo malunga nemithi yonyango, yinto efanelekileyo yokubuza oomachiza. (Iiphemmacists zixabisekileyo kunye nezibonelelo zesigulane ezingaphantsi.)
Uninzi kunje, kukho ukwanda okukhulu kwinani leebhokisi ezimnyama ezifunekayo yi-FDA. Nangona kunjalo, kunyuka kunjalo, kunokuba kunzima ukuba abaninzi abagcini bezilumkiso bayaziphulaphula ngokuzimeleyo ezi lumkiso, bebeka isigulane sokuphepha kwindawo engozini.
Oogqirha, oongikazi, oncedisayo oogqirha, oongikazi, oomachiza, abavelisi beziyobisi kunye nabathengi (nina) bangenisa ingxelo malunga neziyobisi kwi-intanethi kwi-FDA MedWatch ngokusebenzisa iifom eziqhelekileyo.
Iziphumo ezi zivela kule fom ziquka iNkqubo yeNgxelo eNgalunganga. Phakathi kowe-1969 (umhla wokuqalisa) kunye no-2010, iifom ezingaphezulu kwezi-4 zezigidi zithunyelwe kwi-FDA.
Iimpawu zeebhokisi ezimnyama ziyakwenza isicelo kwizilwanyana okanye kwiiklasi ezipheleleyo.
Eyaziwayo Njenge: isilumkiso somnyama omnyama, isilumkiso esinobhokisi
Imizekelo yeebhokisi zeebhokisi ezimnyama:
- I-FDA idinga ibhokisi elimnyama isilumkiso kuzo zonke iintsholongwane ezixinzelelekileyo ngenxa yengozi yokwenza ukuzibulala nokuziphatha kwabaselula abaneminyaka engama-18 no-24 ngexesha lokuqala unyango - ngokubanzi okokuqala ukuya kwiinyanga ezimbini zonyango. Isexwayiso sebhokisi emnyama ekuqaleni saqalwa ngo-2004 kwaye sandiswa ukuze sigqibe izigulane ezineminyaka engaphantsi kweminyaka engama-24 ngo-2007.
- I-Angiotensin-receptor blockers (i-ARB ezifana ne-enalapril okanye i-losartan) inobungozi obukhoyo kwintsana ngexesha lomzimba. Ngaloo ndlela, la mayeza afunekayo acetywayo kufuneka agwenywe ngexesha lokukhulelwa. Njengoko i-ARBS, i-angiotensin-yokuguqula i-inhibitors ye-enzyme (i-ACE inhibitors okanye "i-statins") imishanguzo emininzi eyingozi kwaye iyingozi kumntwana okhulayo kwaye kufuneka igwenywe ngexesha lokukhulelwa.
- I-Aspirin ingabangela i- Reye's syndrome kubantwana. I-Reye's syndrome yisifo esingaqhelekanga esibangela ukuvuvukala kwesibindi okanye ingqondo. Ukuphuhliswa kwe-Reye's syndrome kubantwana kuye kwaxhunyaniswa nokulawulwa kwe-aspirin kubantwana ababuyiselwa kwinkukhu okanye umkhuhlane. Ulawulo lwe-aspirin kubantwana kufuneka luqwalaselwe ngenyango ngugqirha. Ukongezelela, i-aspirin inesibindi esicacileyo sebhokisi ebomnyama esilumkisa ngeengxaki zokungabikho komzimba.
- Iipilisi zomlomo zomlomo zixwayisa ngomngcipheko ophezulu wokubethelwa kwabasetyhini abaneminyaka engama-35 nangaphezulu.
- Ibuprofen kunye nezinye izidakamizwa ezichasayo ezingabhubhisiyo (i-NSAID) ezemidlalo zeebhokisi ezimnyama eziqhagamshelanisayo kunye nokuqhaqha kwamathumbu kunye nezilonda kunye nesifo esibuhlungu (ubuchopho beengqondo).
Ukucatshulwa : Ukuba wena okanye othandekayo uthatha isilwanyana kunye nesilumkiso sebhokisi elimnyama, kukuvumela ukuba uzibonele ngeengozi ezinokuthi zonyango. Ukongezelela ekukhangekeni kwiwebhu, zikhululeke ukucela ugqirha wakho, umphathiswa wezempilo okanye omnye uchwepheshe wezonyango ngoncedo kunye nekhokelo.
Imithombo ekhethiweyo
Eisendrath SJ, Cole SA, Christensen JF, Gutnick D, Cole M, Feldman MD. Ukuxinezeleka. Ku: Feldman MD, Christensen JF, Satterfield JM. eds. Uncedo lweMpilo: Isikhokelo seZenzo zoKliniki, 4e . New York, NY: McGraw-Hill; 2014.
Isiqendu esithi "I-FDA Black Boxed Warnings: Indlela yokuLawula iziyobisi ngokukhuselekileyo" ebhalwe nguNR O'Connor epapashwe kwi-American Family Physician ngo-2010.