Izixwayiso zeBhokisi Elimnyama zikhombisa Izingozi ZamaDakamizwa Odokotela Asemthethweni.
Isixwayiso sebhokisi elimnyama livela ebulaweni lwemithi kadokotela ukuxwayisa abathengi nabahlinzeki bezempilo mayelana nokukhathazeka kokuphepha, njengemiphumela emibi kakhulu noma izingozi ezisongela ukuphila. Isixwayiso sebhokisi elimnyama yisilumkiso esiyingozi kunazo zonke esidingeka yi-US Food and Drug Administration (FDA). Noma yisiphi isikhathi ngemuva kokuba izidakamizwa zivunyelwe, i-FDA ingadinga umenzi ukuthi ahlele isixwayiso sebhokisi elimnyama ohlwini lwamaphakheji emithi.
Uhulumeni wase-US uqhubeka nokuqapha imiphumela engaba yingozi kakhulu yezidakamizwa. Siyakwazi ukubona lezi zimphumela ezimbi ngokusebenzisa uhlelo olubi lwezokubika ngomcimbi kanye neHhovisi lokuHlola kanye ne-Epidemiology, elihlola imithi e-FDA evunyiwe.
Ngokuvamile, izixwayiso zebhokisi ezimnyama zisetshenziselwa ukukhombisa imiphumela engaba yingozi engadingeka ukuba iqhathaniswe nenzuzo engaba khona; Kodwa-ke, izixwayiso zebhokisi elimnyama zingakwazi futhi ukuchaza imininingwane yokusebenzisana kwezidakamizwa, imiyalelo yokuqapha nokuqapha.
I-FDA idinga ukuba abakhiqizi bezidakamizwa ngezimpawu ezimnyama zebhokisi kufanele bafake ulwazi mayelana nokuthi iziphi iziguli ezikhethwe izidakamizwa. Lolu lwazi lunikezwa ngosomakhemisi wakho naku-intanethi. Ngaphezu kwalokho, uma unemibuzo emayelana nemithi yokwelapha, kuwumqondo omuhle ukubuza abaqemisi bakho. (Amakhemikhali ayigugu futhi ayisebenzisiwe ngezidingo zesiguli.)
Iningi lwakamuva, kuye kwaba nokwanda okwenziwe inani lezimpawu ezimnyama ezidingekayo yi-FDA. Naphezu kwalokhu kwanda, nokho kusekhona ukukhathazeka ukuthi abakwa-prescribers abaningi abalaleli ngokucophelela lezi zixwayiso, bebeka ukuphepha kwesiguli engozini.
Odokotela, abahlengikazi, abahlengikazi abahlengikazi, abahlengikazi, abahlengikazi, abakhiqizi bezidakamizwa kanye nabathengi (wena) bangathumela imibiko mayelana nezidakamizwa ku-intanethi ku-FDA MedWatch ngokusebenzisa amafomu afanelekile.
Imiphumela evela kulezi zakhiwo iqukethe uhlelo olubi lokubika umcimbi. Phakathi kuka-1969 (usuku lokuqala) no-2010, amafomu angaphezu kwezigidi ezingu-4 athunyelwe ku-FDA.
Izixwayiso zamabhokisi amnyama zingasebenza kumuthi noma izidakamizwa eziphelele.
Futhi eyaziwa ngokuthi: isixwayiso selebuli omnyama, isixwayiso sebhokisi
Izibonelo zexwayiso zamabhokisi omnyama:
- I-FDA idinga isixwayiso sebhokisi elimnyama kuwo wonke ama-anti-depressants ngenxa yengozi eyengeziwe yokuzibulala nokuziphatha kwabadala abasebaneminyaka ephakathi kuka-18 no-24 ngesikhathi sokunakekelwa kokuqala - ngokuvamile owokuqala kuya ezinyangeni ezimbili zokwelashwa. Lesi sixwayiso sebhokisi elimnyama ekuqaleni sakhiwe ngo-2004 futhi sandiswe ukumboza iziguli ezineminyaka engaphansi kwengu-24 ngo-2007.
- Ama-blockers angiotensin-receptor (ama-ARB afana ne-enalapril noma i-losartan) engozini yileli fetus ngesikhathi sokubeletha. Ngakho-ke, le mithi yokwelashwa kufanele igwenywe ngesikhathi sokukhulelwa. Ngokufana ne-ARBS, i-angiotensin-yokuguqula i-enzyme inhibitors (i-ACE inhibitors noma "izitembu") imishanguzo enamandla kakhulu futhi eyingozi kumntwana okhulayo futhi kufanele igwenywe ngesikhathi sokukhulelwa.
- I-aspirin ingabangela i- Reye's syndrome ezinganeni. I-Reye's syndrome yi-syndrome engavamile eyenza ukuvuvukala kwesibindi noma ubuchopho. Ukuthuthukiswa kwe-Reye's syndrome kubantwana kuye kwaxhunyaniswa nokuphathwa kwe-aspirin kubantwana abaphulukako kusuka enkukhu noma emkhuhlane. Ukuphathwa kwe-aspirin kubantwana kufanele kucatshangelwe ngokucophelela udokotela. Ukwengeza, i-aspirin inebhokisi elimnyama elijwayelekile elixwayisa ukuthi izixwayiso zokungalingani.
- Amaphilisi okubeletha ngomlomo axwayisa ngengozi enkulu yokushaywa isifo kwabesifazane abaneminyaka engama-35 nangaphezulu.
- Ibuprofen kanye nezinye izidakamizwa ezingekho ukuvuvukala (non-steroidal anti-inflammatory drugs (NSAIDs) zezemidlalo izixwayiso zebhokisi elimnyama elizixhumanisa nokugaya kwamathumbu kanye nezilonda kanye nokushaya kwesifo (ubuchopho obuchopho).
Ukucabanga okuhlukanisayo : Uma wena noma othandekayo uthatha isidakamizwa ngesiluleko se-black-box, kuzokusiza ukuba uzijwayeze izingozi ezikhona zelawo mithi. Ngaphezu kokusesha iwebhu, zizwe ukhululekile ukubuza udokotela wakho, umuthi wemithi noma omunye uchwepheshe wezempilo ukunakekelwa neseluleko.
Imithombo ekhethiwe
Eisendrath SJ, Cole SA, Christensen JF, Gutnick D, Cole M, Feldman MD. Ukucindezeleka. Ku: Feldman MD, Christensen JF, Satterfield JM. ama-eds. Imithi Yokuziphatha: Umhlahlandlela Wokuzivocavoca, 4e . ENew York, NY: McGraw-Hill; 2014.
Isihloko esithi "I-FDA Black Boxed Warning: Indlela Yokubhala Izidakamizwa Ngokuphepha" eyabhalwa ngu-NR O'Connor enyatheliswa ku-American Family Physician ngo-2010.