Isixwayiso sebhokisi ebomnyama isilumkiso esisisigxina esakhutshwa yi-US Food and Drug Administration (FDA) ukuba amayeza angakwazi ukuqhuba kwaye ahlale eemarikeni e-United States.
Isilumkiso sebhokisi emnyama sibonakala kwilebula yonyango lonyango ukuba likuqaphele kunye nomboneleli wakho wezempilo malunga naluphi na ukukhathazeka okubalulekileyo, njengemiphumo emibi okanye engozi yokuphila.
Isexwayiso sebhokisi ebomnyama, esaziwa ngokuba "isilumkiso esibhakabhaka somnyama" okanye "isilumkiso esibisiweyo," sibizwa ngokuba ngumngcele omnyama ojikeleze isicatshulwa esibonakalayo kwifakwe yephakeji, ilebula kunye nezinye iincwadi ezichaza imithi (umzekelo , ukupapashwa kweemagazini).
Xa i-FDA ifuna enye
I-FDA idinga isilumkiso sebhokisi emnyama kwiimeko ezilandelayo:
- Amachiza anokubangela iziphumo ezingathandekiyo (ezifana nokubulala, ukusongela ubomi okanye ukuphazamisa ngokusisigxina impendulo). Ngokuxhomekeke kwimeko yakho yezempilo, wena kunye nodokotela wakho kuya kufuneka unqume ukuba ngaba inzuzo enokuthi ithathe izidakamizwa ifanelekile ingozi.
- Impendulo engathintekiyo inokuthi ithintelwe, iyancitshiswe ngokuphindaphindiweyo, okanye iyancitshiswa ngokusetyenziswa ngokufanelekileyo kweziyobisi. Ngokomzekelo, amayeza angakhuseleka ukusebenzisa abantu abadala, kodwa kungekhona kubantwana. Okanye, isilwanyana sinokukhuseleka ukusetyenziswa kubasetyhini abadala abakhulelweyo.
Ulwazi olufunekayo
I-FDA idinga isilumkiso esinobhokisi ukuba sinike isishwankathelo esifutshane semiphumo emibi kunye neengozi ezinxulumene nokuthatha amayeza. Wena kunye nodokotela wakho kufuneka uqaphele olu lwazi xa usenza isigqibo sokuba uqale isilwanyana okanye ukuba ufuna ukutshintshela kwenye iyeza.
Ukuqonda imiphumo emibi kukunceda wenze isigqibo esilungileyo.
Mi zekelo
Ezi zilandelayo ziyimimiselo yeebhokisi ezimnyama eziye zafunwa kwamanye amayeza asetyenziswa ngokuqhelekileyo:
I-Fluoroquinolone Antibiotics
Ngokutsho kwe-FDA, abantu abathatha i-fluoroquinolone antibiotic banomngcipheko ophezulu we-tendinitis kunye nokuphuka kwetonyon, ukulimala okungathi kubangele ukukhubazeka ngokusisigxina. Isixwayiso se-FDA siquka i-Cipro (ciprofloxacin), i-Levaquin (levofloxacin), i-Avelox (moxifloxacin) kunye neminye imithi equkethe i-fluoroquinolone. (Isexwayiso esikhutshwe ngoJulayi 2008.)
Imithi yeSwekile
Ngokutsho kwe-FDA, abantu abanesifo sikashukela bathatha i- Avandia (rosiglitazone) banomngcipheko wokwehluleka kwentliziyo okanye ukuhlaselwa yintliziyo xa sele benesifo senhliziyo okanye basengozini enkulu yokubandezeleka kwentliziyo. (Isexwayiso esikhutshwe ngoNovemba 2007.)
Ukuxhatshazwa kwemithi
Ngokutsho kwe-FDA, yonke imishanguzo enokuxhatshazwayo inomngcipheko wokuzibulala nokuziphatha okuzibulala, okubizwa ngokuba ukuzibulala, kubantu abadala abaselula abaneminyaka eli-18 ukuya ku-24 ngexesha lotyando lokuqala (ngokuqhelekileyo yokuqala ukuya kwiinyanga ezimbini). Isixwayiso se-FDA siquka i-Zoloft (sertraline), i-Paxil (i-paroxetine), i-Lexapro (i-escitalopram), kunye namanye amayeza ahlukumezayo.
(Isexwayiso esikhutshwe ngoMeyi 2007.)
Yintoni Ubonakala Ngayo?
Inkcazo elandelayo evela kwibhile ye-prescription ye-Zoloft ngumzekelo wesilumkiso sebhokisi emnyama.
Ukuzibulala kuBantwana nakwi-Adolescents
Ukuxhatshazwa kweengcinezelo kwandise umngcipheko wokuzibulala nokuzibulala (ukuzibulala) kwizifundo zincinci kwixesha elifutshane kubantwana nakwishumi elivisayo kunye neengxaki ezinkulu zokuxhalabisa (MDD) nezinye izifo zengqondo. Nabani na oqwalasela ukusetyenziswa kweZoloft okanye nayiphi na enye ingxaki yokuxhatshazwayo kumntwana okanye umntwana osemtsha kufuneka alinganise le mngcipheko ngeemfuno zeklinikhi. Izigulane eziqaliswe kunyango kufuneka zijongwe ngokukhawuleza ukwenzela ukunyuka kweeklinikhi, ukuzibulala, okanye ukuguquka okungavamile kokuziphatha. Imindeni kunye nabanonophelo kufuneka bacebiswe ngesidingo sokuqwalasela okufutshane kunye noqhagamshelwano kunye nommiselo. I-Zoloft ayivunyelwanga ukusetyenziswa kwizigulana zezilwanyana ngaphandle kwezigulane ezineengxaki eziphosakeleyo (OCD).
Mayeza Opioid
Ngo-2013, i-FDA ikhuphe isitatimenti esichaza ukubethelwa kwebala lokukhutshwa kwinqanaba lokukhutshwa kwikhosi kuwo wonke umntu okhutshwayo kunye nokuthatha ixesha elide (ER / LA) i-opioid analgesics. Esinye isahlulo salezi zinguqu zibandakanya izilumkiso ezibonisa ibungozi yokusetyenziswa kakubi kwe-opioid, ukuxhatshazwa, ukuxhomekeka. ukudlula kunye nokufa nakwii-dosages ezinconywayo.
Ngo-2016, i-FDA ikhuphe izikhokelo ezifanayo zokubhaliweyo kunye nezilumkiso zonyango lokukhupha i-opioid.
Ngamaqela, utshintsho lusempendulo ngokuthe ngqo kwi-epidemic epidemic e-United States. Ngaphezu koko, i-FDA ifuna ukugxininisa ukuba amayeza e-opioid kufuneka asetyenziswe kuphela kwiimeko zentlungu engapheliyo nayiphi na indlela. Ngamanye amazwi, i-opioids iyingozi kwiziyobisi xa zingasetyenziswa ngokuthobeka phantsi kolawulo lwangobugqirha.
Izikhokelo Zamayeza
Kanye kunye nesilumkiso somnyama ebomnyama, i-FDA idinga ukuba nenkampani yeziyobisi idale isicatshulwa seyeza esineenkcukacha kubaxhasi ngendlela yokusebenzisa ngokuthekileyo imveliso ethile. Izikhokelo ziqulethe ulwazi oluvunywe yi-FDA olunokukunceda ukuba ugweme isiganeko esibi.
Ezi zikhokelo zenzelwe ukuba zinikezwe yi-pharmist yakho ngexesha ozalisekileyo. Izikhokelo zifumaneka kwi-intanethi kwiinkampani zonyango nakwi-FDA. Ngokomzekelo, isikhokelo seyeza ku-Avandia (rosiglitazone) sitholakala kwi-GlaxoSmithKline, umenzi we-Avandia, nakwiziko le-FDA loVavanyo loPhando kunye noPhando.
Ukuba unomdla wokuba iyeza lakho lisixwayiso sebhokisi elimnyama, cela umkhomisi wakho kwaye, ukuba ukhona, fumana ikopi eprintiweyo yesikhokelo sonyango.
Iinkonzo ezongezelelweyo
Isiko soLwazi lwezobisi lwe-Kansas University Medical Centre sigcina uluhlu lwe-intanethi yazo zonke iyeza ezinesilumkiso sebhokisi emnyama. Amayeza adweliswe ngamagama aqhelekileyo. Ukuba uthabatha igama lomenzi wegama , kulungile ukujonga igama eliqhelekileyo .
> Imithombo
> FDA News Release. I-FDA idlulisa izilumkiso eziphuculweyo zokuxilisa i-opioid intlungu yemithi enxulumene nemingcipheko yokusetyenziswa kakubi, ukusetyenziswa kakubi, umlutha, ukugqithisa, kunye nokufa.
> FDA News Release. I-FDA izisa utshintsho lokubhalisa ukukhutshwa kunye neemfuno zokufundwa kwe-postmarket ukwenzela ukukhutshwa kwexesha elide kunye ne-analgesics ye-opioid ende.