Chenjezo lakuda la bokosi ndi chenjezo lolimba kwambiri lochokera ku US Food and Drug Administration (FDA) kuti mankhwala akhoza kunyamula ndikukhalabe pamsika ku United States.
Chenjezo lakuda la bokosi likupezeka pa chilembo cha mankhwala ovomerezeka kuti akuchenjezeni inu ndi wothandizira zaumoyo wanu za mavuto ena ofunika, monga mavuto aakulu kapena zoopsya.
Chenjezo lakuda la bokosi, lodziwikanso ngati "chenjezo lakuda lakuda" kapena "chenjezo la bokosi," limatchulidwa kuti malire akumdima akuzungulira mawu a chenjezo lomwe likupezeka pa phukusi, malemba, ndi mabuku ena omwe akufotokoza za mankhwala (mwachitsanzo , malonda amatsatsa).
Pamene FDA imafuna imodzi
The FDA imafuna mdima wakuda chenjezo pa imodzi mwazifukwazi:
- Mankhwalawa angayambitse mavuto aakulu (monga kupha, kuopseza moyo kapena kusokoneza mwatsatanetsatane zotsatira zoipa) poyerekeza ndi kupindula kwa mankhwalawa. Malingana ndi thanzi lanu, inu ndi dokotala wanu muyenera kusankha ngati phindu la kumwa mankhwala ndi lofunika.
- Zotsatira zovuta kwambiri zingapewe, kuchepetsedwa mwafupipafupi, kapena kuchepetsedwa mwa kugwiritsa ntchito bwino mankhwalawa. Mwachitsanzo, mankhwala akhoza kukhala otetezeka kugwiritsidwa ntchito kwa akuluakulu, koma osati kwa ana. Kapena, mankhwalawa akhoza kukhala otetezeka kuti agwiritsidwe ntchito kwa amayi achikulire omwe alibe mimba.
Zambiri zimafunika
A FDA amafuna kuti machenjezo a mabokosi apereke chidule cha zotsatira zovuta ndi zoopsa zomwe zimakhudzana ndi kumwa mankhwala. Inu ndi dokotala wanu muyenera kudziwa chidziwitso ichi poyambitsa kuyamba mankhwala kapena ngati mutasintha mankhwala ena.
Kumvetsetsa zotsatira zovuta kukuthandizani kupanga chisankho chabwino.
Zitsanzo Zotichenjeza
Zotsatirazi ndi zitsanzo za machenjezo a mabulosi akuda omwe amafunidwa kwa mankhwala ena omwe amagwiritsidwa ntchito:
Fluoroquinolone Antibiotics
Malingana ndi a FDA, anthu omwe amamwa mankhwala a fluoroquinolone amakhala ndi chiopsezo chowonjezereka cha tendinitis ndi kupweteka kwa matope, kuvulaza koopsa komwe kungayambitse kulemala kosatha. Chenjezo la FDA likuphatikizapo Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin) ndi mankhwala ena omwe ali ndi fluoroquinolone. (Chenjezo loperekedwa mu July 2008.)
Mankhwala a shuga
Malinga ndi a FDA, anthu omwe ali ndi shuga amatenga Avandia (rosiglitazone) ali ndi chiopsezo chowonjezeka cha mtima kapena matenda a mtima ngati ali ndi matenda a mtima kapena ali pachiopsezo chachikulu chovutika ndi matenda a mtima. (Chenjezo loperekedwa November 2007.)
Mankhwala Osokoneza Maganizo
Malingana ndi FDA, mankhwala onse opatsirana amakhala ndi chiopsezo chodzipha ndi kudzipha, omwe amadziwika kuti kudzipha, achinyamata omwe ali ndi zaka 18 mpaka 24 pa nthawi yoyamba mankhwala (kawirikawiri yoyamba kufika miyezi iwiri). Chenjezo la FDA limaphatikizapo Zoloft (sertraline), Paxil (paroxetine), Lexapro (escitalopram), ndi mankhwala ena oponderezedwa.
(Chenjezo lochokera May 2007.)
Kodi Munthu Amawoneka Motani?
Chotsatira chotsatira palemba la Zoloft ndi chitsanzo cha chenjezo la bokosi lakuda.
Kudzipha pa Ana ndi Achinyamata
Kuvutika maganizo kunachulukitsa chiopsezo cha kudzipha ndi kudzipha (mwadzidzidzi) muzofupikitsa kafukufuku kwa ana ndi achinyamata omwe ali ndi Matenda Oopsya Ambiri (MDD) ndi matenda ena a maganizo. Aliyense woganizira za kugwiritsa ntchito Zoloft kapena wina aliyense wotetezera matenda m'thupi mwa mwana kapena wachinyamata ayenera kuika chiopsezo chake kuchipatala. Odwala omwe ayamba kulandira mankhwala ayenera kuyang'anitsitsa mwakuya kuwonjezereka, kudzipha, kapena kusintha kosayenera kwa khalidwe. Mabanja ndi osamalirani ayenera kulangizidwa kuti akufunikira kuyang'anitsitsa ndi kuyankhulana ndi malamulo. Zoloft sichivomerezedwa kuti chigwiritsidwe ntchito pa odwala odwala kupatula odwala omwe ali ndi matenda osokoneza bongo (OCD).
Mankhwala Opioid
Mu 2013, a FDA adatulutsa ndemanga yosonyeza kuika chitetezo cha m'kalasi lonse pa maulendo a opioid onse otulutsidwa komanso otalika nthawi yaitali (ER / LA). Chigawo chimodzi cha kusintha kumeneku chimaphatikizapo machenjezo omwe amasonyeza kuti amatha kugwiritsa ntchito molakwika opioid, nkhanza, kudalira. kuwonjezera apo ndi imfa ngakhale pa mlingo woyenera.
Mu 2016, a FDA adatulutsanso maulamuliro ofanana ndi ochenjeza kuti amwe mankhwala opioid atulutsidwa mwamsanga.
Padziko lonse lapansi, kusintha kumeneku kumayankha mliri wa opioid womwe ukugwedeza United States. Komanso, a FDA akufuna kutsimikizira kuti mankhwala a opioid ayenera kugwiritsidwa ntchito pokhapokha ngati akudwala ululu umene sungachiritsidwe mwanjira ina iliyonse. Mwa kuyankhula kwina, opioids ndi mankhwala owopsa ngati sanagwiritsidwe ntchito mosamala mwadindo woyang'anira dokotala.
Kuwongolera Mankhwala
Pogwiritsa ntchito machenjezo a bokosi lakuda, a FDA amafunanso kampani ya mankhwala kuti ipange chitsogozo cha mankhwala chomwe chili ndi mauthenga kwa ogula momwe angagwiritsire ntchito mankhwala enieni. Malangizowa ali ndi mauthenga obvomerezeka a FDA omwe angakuthandizeni kupewa choopsa chochitika.
Malangizowa akuyenera kuperekedwa ndi wamankhwala wanu nthawi yomwe muli ndi mankhwala anu odzazidwa. Malangizowa akupezeka pa intaneti kuchokera ku kampani ya mankhwala ndi ku FDA. Mwachitsanzo, chithandizo cha mankhwala a Avandia (rosiglitazone) chimapezeka kuchokera ku GlaxoSmithKline, wopanga Avandia, komanso kuchokera ku FDA Center for Drug Assessment and Research.
Ngati mukudandaula kuti mankhwala anu ali ndi chenjezo lakuda, funsani wamalonda wanu, ndipo ngati alipo, mupeze kabuku kothandizira mankhwala.
Zoonjezerapo
Dokotala Wofufuza Zamankhwala wa Kansas University Medical Center imakhala ndi mndandanda wa mndandanda wa mankhwala onse omwe ali ndi bokosi lakuda. Mankhwalawa amalembedwa ndi mayina achibadwa. Ngati mukugwiritsa ntchito dzina la mankhwala , ndi bwino kuyang'ana dzina lachibadwa .
> Zosowa
> FDA News Release. FDA imalengeza machenjezo opititsa patsogolo mankhwala opweteka a opioid omwe amatha kusokoneza, kugwiritsa ntchito mowa mwauchidakwa, kuledzera, kupitirira malire, ndi imfa.
> FDA News Release. FDA imalengeza kusintha kwa kusindikiza kwachitetezo ndi zofuna za postmarket zofunikiranso kwa maulgesics otulutsidwa kwa nthawi yaitali.