I-FDA iyawavuma amayeza e-artical arthritis iVoltaren yokusetyenziswa kwe-OTC

Iindaba

Ulawulo lwe-US Food and Drug Administration (FDA) lwamkele i-Voltaren 1% ukuba ithengiswe ngaphezulu kwekhawuntari (i-OTC) ngenkqubo ebizwa ngokuba kukumiselwa ku-OTC. Amayeza e-gel asisiseko abonelela ngoncedo lwethutyana lwentlungu ye-osteoarthritis.

Engaphezulu kwe Abantu abadala abazizigidi ezingama-30 e-US okwangoku ine-osteoarthritis, ngokutsho kwamaZiko oLawulo lweNtsholongwane kunye noThintelo (CDC). Phakathi kwabo, ngaphezulu 8.5 yezigidi ufumene amayeza ka diclofenac sodium (Voltaren generic) ngo-2017. Umvelisi kaVoltaren, GlaxoSmithKline , ithi ifom yejeli yamayeza iya kufumaneka ngaphandle kokuyalelwa ngugqirha wentwasahlobo yowama-2020, kwaye iya kuthengiswa phantsi kwegama iVoltaren Arthritis Pain.

Yintoni iVoltaren?

IVoltaren sisiyobisi esichasayo esinganyangekiyo sokuthintela ukudumba (i-NSAID), utshilo uRamzi Yacoub, uFarm.D., Igosa eliyintloko kwikhemesti le-SingleCare. IVoltaren ekuqaleni yafumana imvume ye-FDA njengeyeza likagqirha ngo-2007. Yenzelwe ngokukodwa iintlungu ezinxulumene nesifo samathambo, ukudumba, nokuqina ezandleni, emadolweni nasezinyaweni. Ayikaze ifundelwe isifo samathambo emqolo, esinqeni, okanye emagxeni. Ayisebenzi kunyango lweiintlobo, ukutyabuka, imivumbo, okanye ukonzakala kwezemidlalo.

Isebenza njani igeltaren gel?

Iyeza lisebenza ngokuthintela ukuveliswa kweekhemikhali zomzimba ezibonisa iintlungu kwindawo ethile yomzimba esetyenziswa kuyo. Nangona ixutywe elukhumbeni, iVoltaren akufuneki isetyenziswe ngokudibeneyo nezinye iintlungu ze-NSAID, njengebuprofen okanye naproxen. Inhlanganisela ye-NSAID ephindwe kabini inokunyusa umngcipheko weziphumo ebezingalindelekanga, ezinjengeengxaki zezintso kunye nezilonda zesisu.

Ngapha koko, iVoltaren ayenzelwanga ukusetyenziswa kwexesha elide. Iintlungu kufuneka ziqale ukuphucula ngaphakathi kweentsuku ezisixhenxe zokusebenzisa iyeza, utshilo uGqirha Yacoub. Ukuba ayenzi njalo, ucebisa ukuba uthethe nogqirha wakho xa kukho into ebaluleke ngakumbi ebangela iintlungu zakho.

Uthini umyalelo wokutshintsha kwi-counter-counter?

Ukumiselwa kutshintsho lwe-OTC yinkqubo apho i-FDA iphinda ifake kwakhona amayeza amiselweyo, ivumela ukuba ithengiswe ngaphezulu kwekhawuntari. Oku kunokwenzeka kuphela xa i-FDA imisela ngokusemthethweni ukuba abathengi banokuyisebenzisa ngokukhuselekileyo nangempumelelo ngaphandle kwesikhokelo sobuchule. Ngamanye amaxesha, ii-FDA's inkqubo yovavanyo lwangaphakathi kukhuthaza utshintsho. Ngokwesiqhelo, nangona kunjalo, abavelisi beziyobisi bacela ukuba ichiza liphinde lihlelwe.

Isibonelelo se-FDA sokuhlaziya kwakhona ukuba idatha yeklinikhi ixhasa ukhuseleko kunye nokusebenza kwe-OTC. Ukusetyenziswa kwe-OTC kufuneka kube kwimeko echongwa ngokulula ngabathengi.Le nkqubo ikhokelele ekwabiweni ngokutsha kwamayeza amaninzi kule minyaka idlulileyo- ukusukela ngo-2001 kuphela, kufutshane namayeza angama-40 athe amiselwa ukuba atshintshe i-OTC, Iingxelo ze-FDA .

Kwimeko kaVoltaren,UGlaxoSmithKline ucele ukuhlelwa kwakhona. Inkampani inika ingxelo yokuba idatha yeklinikhi ibonakalise ukuqala okungaguquguqukiyo kunye nokuxabiseka kwentlungu yokuphumla kwiveki yokuqala.Ayisiyiyo loo nto kuphela, uphando lwenkampani lubonisa ukuba iilebhile zenyani yeziyobisi zikaVoltaren kulula ukuba abathengi baziqonde. Intsingiselo, abaguli bayakwazi ukwenza isigqibo esifanelekileyo sokuzikhathalela ukunyanga iintlungu zesifo samathambo. Iinkcukacha zedatha efanelekileyo kunye nophando olukhokelele ekumiselweni kotshintsho lwe-OTC ziya kukhutshwa kufutshane nomhla wokuphehlelelwa kwe-Voltaren OTC, utshilo uCaitlin Kormann, iNkokeli yoNxibelelwano ngeBrand yase-US ye-GSK Consumer Healthcare.

Kuthetha ntoni ukuhlelwa ngokutsha kweVoltaren kwizigulana?

Ukukwazi ukuthenga ijeli yeVoltaren kwikhawuntari ziindaba ezimnandi kubantu abafuna amayeza, utshilo uGqirha Yacoub. Inika ukhetho olongezelelekileyo kwizigulana ezifuna ukukhululeka kwintlungu, kodwa zingenakho ukubonana nogqirha wazo, uyachaza.

Nangona kunjalo, kusanyanzelekile ukuba uthethe nomboneleli wezempilo okanye usokhemesti malunga neVoltaren- ngakumbi ukuba awuzange uyithathe ngaphambili. Nangona kuyi-OTC ngoku, kusekho iziphumo ebezingalindelekanga onokuzifumana kunye nokunxibelelana kweziyobisi okunokubakho namanye amayeza onokuthi uwathathe, ugqirha Yacoub wongeza. Usokhemesti wakho unokuba sisixhobo esihle ekuncedeni ukuba uqiniseke ukuba ezinye iimeko zonyango, kunye nawaphi na amayeza owathathayo, ayahambelana neVoltaren Gel.

Kukwabaluleke kakhulu ukuba abaguli baqhubeke nokusebenzisa amayeza njengoko kuyalelwe, utshilo. Oku kuthetha ukuthetha nogqirha wakho malunga nezinye iindlela ukuba a) iintlungu azikaphucuki kwisithuba seentsuku ezisixhenxe kwaye b) uziva kufuneka uyisebenzise ngaphezulu kweentsuku ezingama-21 (elona xesha liphezulu lokucetyiswa lonyango).

Ulwazi lwamaxabiso alukabikho kwi-OTC Voltaren-I-GSK ithi iyakubhengezwa (kunye nedatha exhasayo) kufutshane nomhla wokuqaliswa kwentwasahlobo ka-2020. Okwangoku, nangona kunjalo, Ixabiso eliphakathi epokothweni ityhubhu eyi-100 yegramu yohlobo olumiselweyo lweVoltaren 1% yejeli imalunga ne- $ 50.