Amayeza okuphulukana nobunzima uBelviq urhoxile kwimakethi yase-US phakathi kweenkxalabo eziphakamisa umngcipheko womhlaza

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NgoFebruwari 13, Eisai , abenzi beziyobisi zokunciphisa umzimba IBelviq kwaye IBelviq XR (I-lorcaserin HCI), ngokuzithandela ulirhoxisile ichiza kwintengiso yase-US ngesicelo se Ulawulo lwezoKutya kunye noLawulo lweziyobisi (i-FDA) . UBelviq lunyango lonyango, olufumaneka njengepilisi kunye nethebhulethi yokukhupha eyandisiweyo. Yonyusa iimvakalelo zokugcwala ukunceda abaguli batye kancinci kwaye banciphise ubunzima, ngakumbi xa zisetyenziswa kunye nokutya kunye nokuzilolonga. I-FDA yamkele iBelviq ngo-2012 kubantu abadala abatyebe kakhulu; okanye abatyebe kakhulu kwaye baneengxaki zonyango ezinxulumene nobunzima, ezinje ngeswekile, uxinzelelo lwegazi oluphezulu, okanye icholesterol ephezulu.

Kutheni le nto i-FDA icele ukurhoxa kukaBelviq?

Njengengxenye yemvume yokuthengisa ka-Belviq, i-FDA ifuna i-Eisai ukuba yenze uvavanyo lwexesha elide lokuvavanya ukuba ingaba ichiza livelise naziphi na iingxaki zentliziyo kubasebenzisi. Uphononongo lwadlula iminyaka emihlanu kwaye lwajonga kubasebenzisi abayi-12,000 abanesifo sentliziyo kunye / okanye umngcipheko omkhulu wokuba nesifo sentliziyo. Kufumanise ukuba iyeza lenze, ewe, lanceda abasebenzisi ukuba banciphise ubunzima ngaphandle kokuvelisa naziphi na iingxaki ezinkulu zentliziyo.

Kodwa ekuphononongeni idatha, i-FDA yafumanisa ukuba abantu abathatha iBelviq babeneziganeko eziphezulu zomhlaza kunabo bangakhange bathathe iyeza. Ngokutsho kohlalutyo lwe-FDA, i-7.7% yabasebenzisi bakaBelviq bafunyaniswe benomhlaza ngexesha lokufunda, xa kuthelekiswa ne-7.1% yabo bakwiqela lolawulo ababethatha i-placebo (ipilisi engasebenziyo engenalo naliphi na ichiza). Iindidi zomhlaza zibandakanya umhlaza wepancreatic, colorectal, kunye nomhlaza wemiphunga. Ngelixa inkampani ithi ukutolikwa kwedatha kwahlukile kwi-FDA's, i-FDA ithi umngcipheko wokusebenzisa iBelviq ungaphezulu kwezibonelelo zayo.

U-Eisai uyasihlonipha isigqibo se-FDA kwaye usebenza ngokusondeleyo ne-Arhente kwinkqubo yokurhoxa, inkampani ithe ingxelo .

Yintoni ekufuneka yenziwe ngabasebenzisi bakaBelviq?

I-FDA ilumkisa abasebenzisi ukuba bayeke ukuthatha iBelviq kwangoko kwaye baxoxe ngezinye iindlela zokuphulukana nobunzima noogqirha babo. UBelviq usebenza ngokwahlukileyo kunamanye amayeza okuphulukana nobunzima kwimarike, ngenxa yoko kunokwenzeka ukuba ugqirha wakho anokucebisa ukuba usebenzise amayeza ahlukileyo okanye ucebise ukutya kunye nokuzilolonga kuphela.

Ukulahla iBelviq engasetyenziswanga ngokufanelekileyo, yiza iyeza kwi indawo yokubuyela iziyobisi . Ukuba oko akunakwenzeka, i-FDA icebisa ukuba ulahle iBelviq kwinkunkuma:

• Thatha la mayeza kwibhotile kagqirha uze uyixube nento engathandekiyo — umzekelo, inkunkuma yekati okanye indawo yekofu esele isetyenzisiwe. Musa ukuwaphula amacwecwe.
• Beka umxube wamayeza engxoweni yeplastiki etywiniweyo.
• Phosa isikhongozeli kude nenkunkuma yasekhaya.
• Susa isazisi sakho kwibhotile yesigqirha kwaye usisebenzise kwakhona okanye usilahle kwakhona.

Ngaba ndifuna ukongezwa komhlaza?

Hayi. I-FDA ayibizi nakuphi na ukongezwa komhlaza kubasebenzisi beBelviq ngaphaya kwento esele icetyisiwe kuluntu ngokubanzi. Abasebenzisi akufuneki boyike, utshoShaili Gandhi, Pharm.D., Usekela-mongameli wezinto ezenziwa kwifomula kwi-SingleCare. Izigulana kufuneka zithethe noogqirha malunga nayiphi na imibuzo okanye inkxalabo abanokuba nayo. Ingxoxo kufuneka ibandakanye amanye amayeza anokukhetha kunye neendlela zokunciphisa umzimba.

Izigulana okanye ababoneleli ngezempilo banokunika ingxelo ngayo nayiphi na imiba kwi-FDA's MedWatch Information Information kunye neNkqubo yokuNgxelo ngezeMeko eziGwenxa ngokuthi Ukungenisa ingxelo ekwi-intanethi okanye ngokutsalela umnxeba ku-1-800-332-1088.