Mabulosi a Black Box Angapangitse Zowopsa Za Kulembetsa Mankhwala Osokoneza Bongo.
Chenjezo lakuda la bokosi likupezeka pa chilemba cha mankhwala a mankhwala kuti alangize ogula ndi othandizira zaumoyo zokhudzana ndi chitetezo, monga zotsatira zoyipa kapena zoopsya. Chenjezo lakuda la bokosi ndi chenjezo lalikulu kwambiri la mankhwala oyenera ndi US Food and Drug Administration (FDA). Nthawi iliyonse pambuyo povomerezedwa ndi mankhwala, a FDA angafune kuti wopanga apangire chenjezo lakuda la mabulosi omwe ali pamatumba.
Boma la US limapitiriza kuyang'anira zotsatira zowopsa za mankhwala osokoneza bongo. Timatha kuzindikira zotsatira zovuta izi pogwiritsira ntchito Mavuto Otsutsana ndi Zochitika Padzikoli komanso kudzera mu Office of Surveillance and Epidemiology, yomwe imayang'ana mankhwala a FDA omwe amavomerezedwa.
Kawirikawiri, machenjezo a mabulosi akuda akugwiritsidwa ntchito posonyeza zotsatira zovuta zomwe zimafunika kuyerekezera ndi kupindula; Komabe, machenjezo a mabulosi akuda angathenso kudziwa momwe mungagwiritsire ntchito mankhwala osokoneza bongo, malangizo othandizira komanso kuwunika.
The FDA imafuna kuti opanga mankhwala ndi black box machenjezo ayenera kuphatikizapo za odwala omwe akufuna ofuna mankhwala. Chidziwitsochi chikupezeka kudzera mwa katswiri wamasitolo ndi intaneti. Komanso, ngati muli ndi mafunso okhudza mankhwala ovomerezeka, ndibwino kupempha odwala mankhwala. (Azimayi ndi amtengo wapatali komanso osagwiritsidwa ntchito mopitirira malire.)
Posachedwapa, pakhala kuchuluka kwakukulu kwa chiwerengero cha machenjezo a mabulosi akuda a FDA. Komabe, ngakhale kuwonjezeka kumeneku, kudakali kudetsa nkhaŵa kuti olemba ambiri samvetsera mosamala machenjezo awa, kuika chitetezo cha wodwala pangozi.
Madokotala, anamwino, othandizira dokotala, aamwino ogwira ntchito, asayansi, ogulitsa mankhwala osokoneza bongo ndi ogula (inu) angapereke malipoti okhudza mankhwala pa Intaneti pa FDA MedWatch pogwiritsa ntchito mawonekedwe ovomerezeka.
Zotsatira za mafomuwa zikuphatikizidwa ndi Zovuta Zowonongeka Zochitika Pakompyuta. Pakati pa 1969 (kuyambira pachiyambi) ndi 2010, mafomu opitirira mamiliyoni 4 aperekedwa kwa FDA.
Mabulosi a mabulosi amdima angagwiritsidwe ntchito kwa munthu aliyense kapena mankhwala osokoneza bongo.
Zomwe zimatchedwanso: chenjezo lakuda, chizindikiro cha boxed
Zitsanzo za machenjezo a bokosi lakuda:
- A FDA amafunika kuchenjeza bokosi lakuda pazitsamba zonse chifukwa cha chiopsezo chowonjezereka cha kuganiza ndi khalidwe lodzipha achinyamata omwe ali ndi pakati pa 18 ndi 24 pa nthawi yoyamba mankhwala - kawirikawiri yoyamba kwa miyezi iwiri. Chenjezo lakuda lakuda ilo linakhazikitsidwa poyamba mu 2004 ndipo linakula kuti likhale ndi odwala omwe ali ndi zaka zoposa 24 mu 2007.
- Angiotensin-receptor blockers (ARBs monga enalapril kapena losartan) chiopsezo cha mwanayo pakapita nthawi. Choncho, mankhwala ophera antihypertensive ayenera kupeŵa pa nthawi ya mimba. Mofanana ndi ARBS, mavitamini otchedwa angiotensin-converting enzyme inhibitors (ACE inhibitors kapena "statins") ndi mankhwala osokoneza bongo omwe ali owopsa kwa mwana wosabadwayo ndipo ayenera kupeŵa pa nthawi ya mimba.
- Aspirin ikhoza kuyambitsa matenda a Reye kwa ana. Reye's syndrome ndi matenda omwe sagwidwa ndi chiwindi kapena ubongo. Kukula kwa matenda a Reye kwa ana akugwirizana ndi kuyang'anira aspirin kwa ana omwe akuchira matenda a nkhuku kapena chimfine. Udindo wa aspirin kwa ana uyenera kuganiziridwa mozama ndi dokotala. Kuwonjezera pamenepo, aspirin ili ndi chenjezo lakuda la bokosi lomwe limachenjeza za zowopsya.
- Mankhwala oletsa kumwa mankhwala amachenjeza za kuwonjezeka kwa chiwopsezo kwa amayi omwe ali ndi zaka 35 kapena kuposerapo.
- Ibuprofen ndi mankhwala ena oletsa kutentha (non-steroidal anti-inflammatory drugs) (NSAIDs) masewera a black box warnings amawagwirizanitsa ndi m'mimba mwazi komanso zilonda komanso matenda a ubongo.
Kulingalira : Ngati inu kapena wokondedwa mutenga mankhwala ndi chenjezo lakuda-bokosi, muyenera kuti mudziwe nokha zomwe zingakhale zoopsa za mankhwalawa. Kuwonjezera pa kufufuza pa intaneti, omasuka kufunsa dokotala wanu, katswiri wa zamankhwala kapena katswiri wina wa zaumoyo kuti awathandize ndi kuwatsogolera.
Zosankha Zosankhidwa
Eisendrath SJ, Cole SA, Christensen JF, Gutnick D, Cole M, Feldman MD. Kusokonezeka maganizo. Mu: Feldman MD, Christensen JF, Satterfield JM. eds. Mankhwala Omwe Amachita: Njira Yopangira Zochitika Pachipatala, 4e . New York, NY: Hill ya McGraw; 2014.
Nkhani yotchedwa "FDA Black Boxed Warnings: Mmene Mungayankhire Mankhwala Osokoneza Bongo" lolembedwa ndi NR O'Connor lofalitsidwa mu American Family Physician mu 2010.