زائر
FDA Wans abt Ineased isk f Mse Injy with Z
Highest appved dse f heste-weing mediatin d ase ham t mses
The .S. Fd and Dg Administatin tday(1932010) waned patients and heathae pvides abt the ptentia f ineased isk f mse injy fm the heste-weing mediatin Z (simvastatin) 80 mg. Athgh mse injy (aed mypathy) is a knwn side effet with a statins, tday’s waning highights the geate isk f deveping mse injy, inding habdmyysis, f patients when they ae pesibed and se highe dses f this dg. habdmyysis is the mst seis fm f mypathy and an ead t sevee kidney damage, kidney faie, and smetimes death.
“eview f simvastatin is pat f an nging FDA efft t evaate the isk f statin-assiated mse injy and t pvide that infmatin t the pbi as it bemes avaiabe,” said Ei man, M.D., Depty Diet f FDA’s Divisin f Metabism and Endingy Pdts (DMEP). “It’s imptant f patients and heathae pfessinas t nside a the ptentia isks and knwn benefits f any dg befe deiding n any ne theapy dse f theapy.”
Simvastatin is sd as a singe-ingedient genei mediatin and as the band-name Z. It as is sd in mbinatin with ezetimibe as Vytin, and in mbinatin with niain as Sim.
FDA’s eview f new infmatin n the isk f mse injy is deived fm inia tias, bsevatina stdies, advese event epts, and pesiptin se data. The ageny as is eviewing data fm the SEAH (Stdy f the Effetiveness f Additina edtins in heste and Hmysteine) tia, whih evaated maj adivasa events, sh as heat attak, evasaizatin and adivasa death, in patients taking 80 mg mpaed t 20 mg f simvastatin. SEAH as inded data n mse injy in patients taking simvastatin.
FDA is mmitted t infming the pbi abt its nging safety eview f dgs and wi pdate the pbi as sn as the eview f simvastatin is mpete.
(1932010)FDA
Highest appved dse f heste-weing mediatin d ase ham t mses
The .S. Fd and Dg Administatin tday(1932010) waned patients and heathae pvides abt the ptentia f ineased isk f mse injy fm the heste-weing mediatin Z (simvastatin) 80 mg. Athgh mse injy (aed mypathy) is a knwn side effet with a statins, tday’s waning highights the geate isk f deveping mse injy, inding habdmyysis, f patients when they ae pesibed and se highe dses f this dg. habdmyysis is the mst seis fm f mypathy and an ead t sevee kidney damage, kidney faie, and smetimes death.
“eview f simvastatin is pat f an nging FDA efft t evaate the isk f statin-assiated mse injy and t pvide that infmatin t the pbi as it bemes avaiabe,” said Ei man, M.D., Depty Diet f FDA’s Divisin f Metabism and Endingy Pdts (DMEP). “It’s imptant f patients and heathae pfessinas t nside a the ptentia isks and knwn benefits f any dg befe deiding n any ne theapy dse f theapy.”
Simvastatin is sd as a singe-ingedient genei mediatin and as the band-name Z. It as is sd in mbinatin with ezetimibe as Vytin, and in mbinatin with niain as Sim.
FDA’s eview f new infmatin n the isk f mse injy is deived fm inia tias, bsevatina stdies, advese event epts, and pesiptin se data. The ageny as is eviewing data fm the SEAH (Stdy f the Effetiveness f Additina edtins in heste and Hmysteine) tia, whih evaated maj adivasa events, sh as heat attak, evasaizatin and adivasa death, in patients taking 80 mg mpaed t 20 mg f simvastatin. SEAH as inded data n mse injy in patients taking simvastatin.
FDA is mmitted t infming the pbi abt its nging safety eview f dgs and wi pdate the pbi as sn as the eview f simvastatin is mpete.
(1932010)FDA
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