Belviq yemwe wataya mankhwala ochepetsa kulemera kwake atachotsedwa pamsika waku US pakati pazovuta zimabweretsa chiwopsezo cha khansa
NkhaniPa Feb. 13, Eisai , omwe amapanga mankhwala ochepetsa thupi Zamgululi ndipo Malangizo: Belviq XR (lorcaserin HCI), mwakufuna kwawo adachotsa mankhwalawo kumsika waku US pempho la US Administration and Drug Administration (FDA) . Belviq ndi mankhwala akuchipatala, omwe amapezeka ngati piritsi komanso piritsi lotulutsa nthawi yayitali. Zimawonjezera kukhutira kuthandiza odwala kudya pang'ono ndikuchepetsa thupi, makamaka akagwiritsidwa ntchito limodzi ndi zakudya komanso masewera olimbitsa thupi. A FDA adavomereza Belviq mu 2012 kwa achikulire omwe onenepa; kapena omwe ali onenepa kwambiri komanso ali ndi zovuta zamankhwala, monga matenda ashuga, kuthamanga kwa magazi, kapena cholesterol.
Chifukwa chiyani a FDA adapempha kuti Belviq achoke?
Monga gawo la kuvomereza kwa malonda kwa Belviq, a FDA amafuna kuti Eisai ayese kuyesa kwanthawi yayitali pofufuza ngati mankhwalawa amatulutsa mavuto amtima mwa ogwiritsa ntchito. Kafukufukuyu adatenga zaka zisanu ndikuyang'ana ogwiritsa ntchito 12,000 omwe ali ndi matenda amtima komanso / kapena chiopsezo chachikulu chokhala ndi matenda amtima. Inapeza kuti mankhwalawa amathandizadi ogwiritsa ntchito kuti achepetse thupi osatulutsa mavuto amtima.
Koma powunikiranso izi, a FDA adapeza kuti anthu omwe amatenga Belviq anali ndi vuto lalikulu la khansa kuposa omwe sanamwe mankhwalawo. Malinga ndi kuwunika kwa FDA, 7.7% ya ogwiritsa ntchito a Belviq adapezeka ndi khansa panthawi yophunzira, motsutsana ndi 7.1% mwa omwe ali mgulu lolamulira omwe amatenga placebo (mapiritsi osagwira ntchito omwe analibe mankhwala aliwonse). Mitundu ya khansa inali khansa ya kapamba, yamphongo, komanso yamapapo. Pomwe kampaniyo imati kumasulira kwake kwa dongosololi kumasiyana ndi a FDA, a FDA akuti kuopsa kogwiritsa ntchito Belviq kumaposa phindu lake.
Eisai amalemekeza lingaliro la FDA ndipo akugwira ntchito limodzi ndi Agency pantchito yochotsa, kampaniyo idatero mawu .
Kodi ogwiritsa ntchito Belviq ayenera kuchita chiyani?
A FDA amachenjeza ogwiritsa ntchito kuti asiye kumwa Belviq nthawi yomweyo ndikukambirana njira zina zochepetsera ndi madotolo awo. Belviq amagwira ntchito mosiyana ndi mankhwala ena ochepetsa kulemera pamsika, chifukwa chake ndizotheka dokotala wanu angakulangizeni kugwiritsa ntchito mankhwala osiyana kapena amalimbikitsa zakudya ndi zolimbitsa thupi zokha.
Kutaya Belviq wosagwiritsidwa ntchito moyenera, bweretsani mankhwalawa kwa a malo obwezera mankhwala osokoneza bongo . Ngati sizingatheke, a FDA akukulimbikitsani kuti muthe Belviq mu zinyalala:
- Chotsani mankhwala mu botolo la mankhwala ndikusakaniza ndi chinthu chosakhutiritsa-mwachitsanzo, zinyalala zamphaka kapena malo omwe mumamwa khofi. Osaphwanya mapiritsi.
- Ikani mankhwala osakaniza mu thumba la pulasitiki losindikizidwa.
- Ponyani chidebecho ndi zinyalala zapakhomo.
- Chotsani chizindikiritso chanu mu botolo la mankhwala ndikubwezeretsanso kapena chitayireni kutali.
Kodi ndiyenera kuwunikanso zina za khansa?
Ayi. FDA sikukuyitanitsa kuwunika kwina kwa khansa kwa ogwiritsa ntchito a Belviq kupitirira zomwe zalangizidwa kale kwa anthu onse. Ogwiritsa ntchito sayenera kuchita mantha, akuteroShaili Gandhi, Pharm.D., Wachiwiri kwa purezidenti wa formulary ku SingleCare. Odwala ayenera kulankhula ndi madokotala za mafunso kapena nkhawa zomwe angakhale nazo. Zokambiranazi ziphatikizira njira zina zamankhwala ndi njira zochepetsera thupi.
Odwala kapena othandizira azaumoyo atha kufotokozera zilizonse ku FDA's MedWatch Safety Information ndi Adverse Event Reporting Program by kutumiza lipoti lapaintaneti kapena poyimba 1-800-332-1088.