Isidakamizwa sokunciphisa isisindo uBelviq uhoxisiwe emakethe yase-US phakathi kokukhathazeka kuphakamisa ingozi yomdlavuza

Izindaba

NgoFebhuwari 13, I-Eisai , abenzi bomuthi wokwehlisa isisindo UBelviq futhi IBelviq XR (lorcaserin HCI), ngokuzithandela wasusa lesi sidakamizwa emakethe yase-U.S. ngesicelo se- Ukuphathwa Kwezokudla Nezidakamizwa e-U.S. . I-Belviq ngumuthi kadokotela, otholakala njengethebhulethi kanye nethebhulethi ekhishwa enwetshiwe. Kwandisa imizwa yokugcwala ukusiza iziguli zidle kancane futhi zinciphise isisindo, ikakhulukazi lapho zisetshenziswa kanye nokudla nokuvivinya umzimba. I-FDA ivume iBelviq ngo-2012 kubantu abadala abakhuluphele; noma abakhuluphele kakhulu futhi banezinkinga zokwelashwa ezihlobene nesisindo, njengesifo sikashukela, umfutho wegazi ophakeme, noma i-cholesterol ephezulu.

Kungani i-FDA icele ukuhoxiswa kukaBelviq?

Njengengxenye yemvume yokuthengisa kaBelviq, i-FDA idinga ukuthi i-Eisai yenze isilingo sesikhathi eside ehlola ukuthi lo muthi ukhiqize noma yiziphi izinkinga zenhliziyo kubasebenzisi. Ucwaningo luthathe iminyaka emihlanu futhi lwabheka abasebenzisi abayi-12,000 abanesifo senhliziyo nemithambo yegazi kanye / noma nengozi enkulu yokuba nesifo senhliziyo. Kutholile ukuthi umuthi, empeleni, usize abasebenzisi ukunciphisa umzimba ngaphandle kokukhiqiza noma yiziphi izinkinga ezinkulu zenhliziyo.

Kodwa ekubuyekezeni idatha, i-FDA ithole ukuthi abantu abathatha iBelviq banezigameko eziphezulu zomdlavuza kunalabo abangazange bawuthathe umuthi. Ngokuya ngokuhlaziywa kwe-FDA, u-7.7% wabasebenzisi beBelviq batholakala benomdlavuza ngesikhathi sokufunda, kuqhathaniswa no-7.1% walabo abaseqenjini lokulawula ababethatha i-placebo (iphilisi elingasebenzi elingaqukethe noma imuphi umuthi). Izinhlobo zomdlavuza zibandakanya umdlavuza we-pancreatic, colorectal, ne-lung. Ngenkathi inkampani ithi ukuhunyushwa kwayo kwedatha kwehlukile kwe-FDA's, i-FDA ithi izingozi zokusebenzisa iBelviq zidlula izinzuzo zayo.

I-Eisai iyasihlonipha isinqumo se-FDA futhi isebenza ngokubambisana ne-Agency ngenqubo yokuhoxa, kusho inkampani ku-a isitatimende .

Yini okufanele yenziwe ngabasebenzisi bakaBelviq?

I-FDA ixwayisa abasebenzisi ukuthi bayeke ukuthatha uBelviq ngokushesha futhi baxoxe ngezinye izindlela zokwehlisa isisindo nodokotela babo. UBelviq usebenza ngokuhlukile kuneminye imishanguzo yokwehlisa isisindo emakethe, ngakho-ke kungenzeka ukuthi udokotela wakho angakweluleka ngokusebenzisa umuthi ohlukile noma ancoma ukudla nokuzivocavoca wedwa.

Ukulahla iBelviq engasetshenziswanga kahle, letha umuthi ku indawo yokubuyisa izidakamizwa . Uma lokho kungenzeki, i-FDA incoma ukuthi ulahle iBelviq kudoti:

• Khipha umuthi ebhodleleni lokudokotela bese ulixuba nento engakhangi — ngokwesibonelo, udoti wekati noma izinkundla zekhofi ezisetshenzisiwe. Musa ukuchoboza amaphilisi.
• Faka ingxube yemithi esikhwameni sepulasitiki esivaliwe.
• Phonsa isitsha kude nodoti wasendlini yakho.
• Susa umazisi wakho ebhodleleni kadokotela bese uwusebenzisa kabusha noma uwulahle futhi.

Ngabe ngidinga ukuhlolwa komdlavuza okwengeziwe?

Cha. I-FDA ayifuni ukuhlolelwa umdlavuza okwengeziwe kwabasebenzisi bakaBelviq ngaphezu kwalokho osekuvele kwalulekwa umphakathi jikelele. Abasebenzisi akufanele bathuke, uthiUShaili Gandhi, Pharm.D., Usekela mongameli wezinto ezenziwa e-SingleCare. Iziguli kufanele zikhulume nodokotela bazo nganoma yimiphi imibuzo noma ukukhathazeka abangase babe nakho. Ingxoxo kufanele ifake ezinye izindlela zokwelashwa kanye nezindlela zokwehlisa isisindo.

Iziguli noma abahlinzeki bezempilo bangabika noma yiziphi izingqinamba kuhlelo lwe-FDA's MedWatch Safety Information and Adverse Event Reporting Programme ngo- ukuhambisa umbiko oku-inthanethi noma ngokushayela ku-1-800-332-1088.