زائر
May 26, 2010 — The S Fd and Dg Administatin (FDA) annned tday that it has evised the abe f istat (Xenia) t inde new safety infmatin abt ae ases f sevee ive injy epted with the se f the weight-ss mediatin.
In additin, the Dg Fats abe f an ve-the-nte, 60-mg fmatin f istat (Ai) wi nw feate a waning abt sevee ive injy. Xenia, avaiabe ny by pesiptin, is a 120-mg fmatin.
ast Agst, the ageny annned that it was stdying a pssibe ink between istat and ive injy. Tday's annnement is based n a mpeted FDA eview f a avaiabe data fm peinia and inia tias, pstmaketing stdies, and dg tiizatin fm Api 1999 thgh Agst 7, 2009.
Signas f signifiant ive damage did nt emege in peinia inia tias. Hweve, the FDA identified 13 pstmaketing ases f sevee ive injy — 12 f them feign ases invving Xenia and the the a S ase invving Ai. Sme patients died needed a ive tanspant.
The FDA stated that it has nt yet estabished a asa eatinship between istat se and sevee ive injy and ited 3 fats making this deteminatin diffit:
* The 13 ases f sevee ive injy stand angside an estimated 40 miin pepe wh have sed sme vesin f istat.
* Sme f the 13 patients sed the dgs had nditins that might have ntibted t sevee ive injy.
* Sevee ive injy an witht a distint easn in pepe nt taking dgs.
The FDA is advising iniians t instt istat ses t ept any symptms f hepati dysfntin sh as anexia, pits, jandie, dak ine, ight-ed sts, ight ppe qadant pain. Patients shd disntine istat theapy if ive injy is sspeted.
Me infmatin n tday's FDA annnement is avaiabe n the ageny's Web site.
In additin, the Dg Fats abe f an ve-the-nte, 60-mg fmatin f istat (Ai) wi nw feate a waning abt sevee ive injy. Xenia, avaiabe ny by pesiptin, is a 120-mg fmatin.
ast Agst, the ageny annned that it was stdying a pssibe ink between istat and ive injy. Tday's annnement is based n a mpeted FDA eview f a avaiabe data fm peinia and inia tias, pstmaketing stdies, and dg tiizatin fm Api 1999 thgh Agst 7, 2009.
Signas f signifiant ive damage did nt emege in peinia inia tias. Hweve, the FDA identified 13 pstmaketing ases f sevee ive injy — 12 f them feign ases invving Xenia and the the a S ase invving Ai. Sme patients died needed a ive tanspant.
The FDA stated that it has nt yet estabished a asa eatinship between istat se and sevee ive injy and ited 3 fats making this deteminatin diffit:
* The 13 ases f sevee ive injy stand angside an estimated 40 miin pepe wh have sed sme vesin f istat.
* Sme f the 13 patients sed the dgs had nditins that might have ntibted t sevee ive injy.
* Sevee ive injy an witht a distint easn in pepe nt taking dgs.
The FDA is advising iniians t instt istat ses t ept any symptms f hepati dysfntin sh as anexia, pits, jandie, dak ine, ight-ed sts, ight ppe qadant pain. Patients shd disntine istat theapy if ive injy is sspeted.
Me infmatin n tday's FDA annnement is avaiabe n the ageny's Web site.