FDA imavomereza mankhwala am'magazi a Voltaren kuti agwiritse ntchito OTC

Nkhani

US Food and Drug Administration (FDA) idavomereza Voltaren 1% kuti igulitsidwe pa kauntala (OTC) kudzera munjira yotchedwa kusintha kwa kusintha kwa OTC. Mankhwala a gel osakaniza amapereka mpumulo wa kanthawi kochepa kwa ululu wa nyamakazi.

Kuposa Akuluakulu 30 miliyoni ku US pakadali pano ali ndi osteoarthritis, malinga ndi Centers for Disease Control and Prevention (CDC). Mwa iwo, opitilira 8.5 miliyoni analandira mankhwala a diclofenac ndi sodium (Voltaren generic) mu 2017. Wopanga Voltaren, GlaxoSmithKline , akuti mtundu wa gel osakaniza wamankhwala azitha kugulidwa popanda mankhwala pofika masika 2020, ndipo udzagulitsidwa pansi pa dzina la Voltaren Arthritis Pain.

Kodi Voltaren ndi chiyani?

Voltaren ndi mankhwala osakanikirana ndi kutupa (NSAID), atero a Ramzi Yacoub, Pharm.D., Wamkulu wamaofesi ku SingleCare. Voltaren poyamba adalandira chivomerezo cha FDA ngati mankhwala akuchipatala mu 2007. Amapangidwira makamaka zowawa zokhudzana ndi nyamakazi, kutupa, ndi kuuma mmanja, mawondo, ndi mapazi. Sanaphunzire za nyamakazi mumsana, m'chiuno, kapena m'mapewa. Sizothandiza kuchizazovuta, zopindika, zopweteka, kapena zovulala zamasewera.

Kodi gel osakaniza Voltaren amagwira ntchito bwanji?

Mankhwalawa amagwira ntchito poletsa kupangika kwamankhwala owonetsa ululu m'thupi makamaka m'thupi momwe amagwiritsidwira ntchito. Ngakhale idapakidwa pakhungu, Voltaren sayenera kugwiritsidwa ntchito molumikizana ndi othandizira ena a NSAID, monga ibuprofen kapena naproxen. Kuphatikizika kwa NSAID kawiri kumakulitsa chiopsezo cha zotsatirapo, monga mavuto a impso ndi zilonda zam'mimba.

Kuphatikiza apo, Voltaren sikutanthauza kuti mugwiritse ntchito kwakanthawi. Ululu uyenera kuyamba kusintha patadutsa masiku asanu ndi awiri akugwiritsa ntchito mankhwalawa, atero Dr. Yacoub. Ngati sichoncho, amalimbikitsa kuti mukalankhule ndi dokotala ngati china chake chachikulu chikukupweteketsani.

Kodi lamulo lanu kuti musinthe pa-kauntala ndi liti?

Kalata yosinthira OTC ndi njira yomwe FDA imasinthiranso mankhwala omwe amalembedwa, kulola kuti agulitsidwe pa kontrakitala. Izi zitha kuchitika pokhapokha a FDA akatsimikiza kuti ogula atha kuzigwiritsa ntchito mosamala popanda chitsogozo cha akatswiri. Nthawi zina, a FDA's ndondomeko yowunika mkati imalimbikitsa kusinthaku. Nthawi zambiri, komabe, opanga mankhwala amafunsanso kuti mankhwalawa asinthidwe.

A FDA amalola kulembanso ngati deta komanso zamankhwala zithandizira chitetezo ndikugwira bwino ntchito kwa OTC. Kugwiritsa ntchito kwa OTC kuyenera kukhala kwa zinthu zomwe makasitomala amagwiritsa ntchito mosavuta.Njirayi yapangitsa kuti mankhwala ambiri asinthidwe kwazaka zambiri-kuyambira 2001 yokha, pafupifupi mankhwala 40 adalandira mankhwala osinthidwa ku OTC switch, Malipoti a FDA .

Pankhani ya Voltaren,GlaxoSmithKline adapempha kuti asinthidwe. Kampaniyo idanenanso kuti zidziwitso zachipatala zidawonetsa kuyambika kokometsa komanso koyenera kwa mpumulo kumapeto kwa sabata limodzi.Osati izi zokha, kafukufuku wa kampaniyo akuwonetsa kuti chizindikiro cha Voltaren chokhudza mankhwala osokoneza bongo ndikosavuta kwa ogula kuti amvetse. Kutanthauza, odwala amatha kupanga chisankho choyenera chodzisamalira kuti athetse ululu wamatenda. Zambiri pazakufufuza ndi zomwe zidatsogolera ku OTC switch zidzatulutsidwa pafupi ndi tsiku loyambitsa Voltaren OTC, atero a Caitlin Kormann, Mtsogoleri wa US Brand Communications wa GSK Consumer Healthcare.

Kodi kusinthidwa kwa Voltaren kumatanthauza chiyani kwa odwala?

Kutha kugula gel osakaniza a Voltaren pakauntala ndi nkhani yabwino kwa anthu omwe amafunikira mankhwalawa, akutero Dr. Yacoub. Amapereka zosankha zina kwa odwala omwe amafunikira kupumula, koma sangathe kuwona dotolo wawo, akufotokoza.

Komabe, ndikofunikira kuti mulankhule ndi wothandizira zaumoyo kapena wamankhwala za Voltaren-makamaka ngati simunalandirepo. Ngakhale ndi OTC tsopano, pali zovuta zina zomwe mungakumane nazo komanso momwe mungagwiritsire ntchito mankhwala ndi mankhwala ena omwe mukumwa, Dr. Yacoub akuwonjezera. Wosunga mankhwala anu akhoza kukuthandizani kuti muwonetsetse kuti zina zamankhwala, komanso mankhwala omwe mumamwa, ndi ogwirizana ndi Voltaren Gel.

Ndikofunikanso kwambiri kuti odwala apitilize kugwiritsa ntchito mankhwalawa monga akuuzira, akutero. Izi zikutanthawuza kuyankhula ndi dokotala pazomwe mungachite ngati a) kupweteka sikukuyenda bwino pasanathe masiku asanu ndi awiri ndipo b) mukumva kuti muyenera kugwiritsa ntchito masiku opitilira 21 (kutalika kwa chithandizo chamankhwala).

Zambiri zamitengo sizikupezeka ku OTC Voltaren-GSK akuti idzalengezedwa (limodzi ndi zomwe zithandizira) pafupi ndi tsiku loyambitsa masika 2020. Pakadali pano, komabe Mtengo wokwera mthumba pa chubu 100 g ya mankhwala achibadwa a Voltaren 1% gel pafupifupi $ 50.