I-FDA igunyaza imishanguzo yama-topical arthritis Voltaren yokusetshenziswa kwe-OTC

Izindaba

I-U.S. Food and Drug Administration (FDA) igunyaze i-Voltaren 1% ukuthi ithengiswe phezu kwe-counter (OTC) ngenqubo ebizwa nge-prescription to switch ye-OTC. Imithi yama-topical gel inikeza ukukhululeka kwesikhashana kobuhlungu be-osteoarthritis.

Ngaphezu kwe Abantu abadala abayizigidi ezingama-30 e-U.S. njengamanje bane-osteoarthritis, ngokusho kweCenters for Disease Control and Prevention (CDC). Phakathi kwabo, ngaphezu kwe- 8.5 million uthole incwadi kadokotela ye i-diclofenac sodium (Voltaren generic) ngo-2017. Umkhiqizi kaVoltaren, GlaxoSmithKline , ithi ifomu le-gel elijwayelekile lomuthi lizotholakala ngaphandle kokuyalelwa ngudokotela entwasahlobo ka-2020, futhi lizothengiswa ngaphansi kwegama le-Voltaren Arthritis Pain.

Yini iVoltaren?

I-Voltaren iyisidakamizwa esisebenza ngama-anti-inflammatory (NSAID), kusho uRamzi Yacoub, i-Pharm.D., Oyisikhulu esiphezulu sekhemisi kwa-SingleCare. IVoltaren ekuqaleni yathola ukuvunyelwa kwe-FDA njengomuthi kadokotela ngo-2007. Yenzelwe ngqo izinhlungu ezihlobene nesifo samathambo, ukuvuvukala nokuqina ezandleni, emadolweni nasezinyaweni. Akufundelwanga isifo samathambo emgogodleni, okhalweni, noma emahlombe. Akusebenzi futhi ukwelashwa kwe-izinkinga, ukuqhuma, imihuzuko, noma ukulimala kwezemidlalo.

Ngabe iVoltaren gel isebenza kanjani?

Imithi isebenza ngokuvimba ukukhiqizwa kwamakhemikhali okusayina ubuhlungu bomzimba endaweni ethile yomzimba ofakwa kuyo. Yize ihlikihliwe esikhunjeni, iVoltaren akufanele isetshenziswe ngokuhlangana nezinye izinhlungu zokunciphisa izinhlungu ze-NSAID, njenge-ibuprofen noma i-naproxen. Inhlanganisela ephindwe kabili ye-NSAID izokhuphula ubungozi bemiphumela emibi, njengezinkinga zezinso nezilonda zesisu.

Ngaphezu kwalokho, iVoltaren ayenzelwe ukusetshenziswa isikhathi eside. Ubuhlungu kufanele buqale ukuthuthuka zingakapheli izinsuku eziyisikhombisa usebenzise umuthi, kusho uDkt. Yacoub. Uma kungenjalo, uncoma ukuthi ukhulume nodokotela wakho uma kwenzeka okuthile okubaluleke kakhulu kubangela ubuhlungu bakho.

Uyini umuthi kadokotela wokushintsha okwe-counter?

Umuthi wokushintshela ku-OTC switch inqubo lapho i-FDA ifaka kabusha imithi kadokotela, iyivumela ukuthi ithengiswe ngaphezulu kwekhawunta. Lokhu kungenzeka kuphela lapho i-FDA inquma ngokusemthethweni ukuthi abathengi bangayisebenzisa ngokuphepha nangempumelelo ngaphandle kokuholwa nguchwepheshe. Kwesinye isikhathi, ama-FDA's inqubo yokubuyekezwa kwangaphakathi igqugquzela inkinobho. Ngokuvamile, noma kunjalo, abenzi bezidakamizwa bacela ukuthi umuthi ubekwe kabusha.

I-FDA inika ukuhlukaniswa kabusha uma idatha yemitholampilo isekela ukuphepha nokusebenza kwe-OTC. Ukusetshenziswa kwe-OTC kufanele kube kwesimo esibonwa kalula ngabathengi.Le nqubo iholele ekuhlukanisweni kabusha kwemithi eminingi eminyakeni edlule — kusukela ngo-2001 kuphela, cishe imishanguzo engaba ngu-40 ithole imiyalelo yokushintshwa kwe-OTC, Imibiko ye-FDA .

Endabeni kaVoltaren,UGlaxoSmithKline ucele ukwakhiwa kabusha. Le nkampani ibika ukuthi idatha yomtholampilo ikhombise ukuqala okungaguquguquki nokwazisayo kokukhululeka kobuhlungu ekuqaleni kwesonto lokuqala.Akugcini lapho, ucwaningo lwenkampani lukhombisa ukuthi ilebuli yamaqiniso ezidakamizwa iVoltaren kulula ukuthi abathengi bayiqonde. Okusho ukuthi, iziguli ziyakwazi ukwenza isinqumo esifanele sokukhetha ukuzinakekela ukwelapha ubuhlungu be-arthritis. Imininingwane yedatha esebenzayo nocwaningo okuholele ekutholweni kokushintshelwa kwe-OTC kuzokhishwa eduze nosuku lokuqaliswa kwe-Voltaren OTC, kusho uCaitlin Kormann, Umholi Wezokuxhumana Komkhiqizo wase-US we-GSK Consumer Healthcare.

Kusho ukuthini ukuhlelwa kabusha kweVoltaren ezigulini?

Ikhono lokuthenga ijeli leVoltaren phezu kwekhawunta yizindaba ezinhle kubantu abadinga umuthi, kusho uDkt. Yacoub. Inikeza izinketho ezingeziwe ezigulini ezidinga ukukhululeka kobuhlungu, kepha kungenzeka zingakwazi ukubona udokotela wazo, uyachaza.

Kodwa-ke, kusadingeka ukuthi ukhulume nomhlinzeki wezokunakekelwa kwempilo noma wemithi ngeVoltaren — ikakhulukazi uma ungakaze uyithathe ngaphambilini. Noma kuyi-OTC manje, kusenemiphumela engemihle ongahle uhlangane nayo nokuhlangana kwezidakamizwa okungahle kube khona oyisebenzisayo, uDkt Yacoub uyanezela. Usokhemisi wakho angaba ngumthombo omkhulu wokukusiza ukuthi uqiniseke ukuthi ezinye izimo zakho zezokwelapha, kanye nanoma imiphi imithi oyiphuzayo, iyahambisana neVoltaren Gel.

Kubaluleke kakhulu futhi ukuthi iziguli ziqhubeke nokusebenzisa umuthi njengokuyalelwa, usho kanjalo. Lokhu kusho ukukhuluma nodokotela wakho ngezinye izinketho uma a) ubuhlungu abukathuthuki zingakapheli izinsuku eziyisikhombisa futhi b) uzizwa ukuthi udinga ukubusebenzisa ngaphezu kwezinsuku ezingama-21 (ubude besikhathi sokwelashwa obuphakanyisiwe).

Imininingwane yamanani ayikatholakali ku-OTC Voltaren — I-GSK ithi izomenyezelwa (kanye nedatha esekelayo) eduze nosuku lokuqalisa lwentwasahlobo lwango-2020. Okwamanje, kepha Intengo emaphakathi ephaketheni ukuthola ithubhu engu-100 gram yenguqulo kadokotela ejwayelekile ye-Voltaren 1% ijeli icishe ibe ngama- $ 50.