زائر
The .S. Fd and Dg Administatin tday is annning safety abe hanges f the heste-weing mediatin simvastatin bease the highest appved dse--80 miigam (mg)--has been assiated with an eevated isk f mse injy mypathy, patiay ding the fist 12 mnths f se.
The ageny is emmending that simvastatin 80 mg be sed ny in patients wh have been taking this dse f 12 mnths me and have nt expeiened any mse txiity. It shd nt be pesibed t new patients. Thee ae as new ntaindiatins and dse imitatins f when simvastatin is taken with etain the mediatins.
The hanges t the abe f simvastatin-ntaining mediatins ae based n the FDA's eview f the ests f the seven-yea Stdy f the Effetiveness f Additina edtins in heste and Hmysteine inia tia, the inia tia data, and anayses f advese events sbmitted t the FDA's Advese Event epting System. A shwed that patients taking simvastatin 80 mg daiy had an ineased isk f mse injy mpaed t patients taking we dses f simvastatin the statin dgs. The isk f mse injy is highest ding the fist yea f teatment with the 80 mg dse f simvastatin, is ften the est f inteatins with etain the mediines, and is feqenty assiated with a geneti pedispsitin f simvastatin-eated mse injy.
Simvastatin is sd nde the band-name Z and as a singe-ingedient genei pdt. It is as sd in mbinatin with ezetimibe as Vytin and in mbinatin with Niain as Sim.
The FDA has evised the dg abes f simvastatin and Vytin t inde the new 80 mg dsing estitins. The ageny as evised the abes f simvastatin, Vytin and Sim t inde new dsing emmendatins when these dgs ae sed with etain mediatins that inteat t inease the eve f simvastatin in the bdy, whih an inease the isk f mypathy. Patients wh ae nabe t adeqatey we thei eve f D- n simvastatin 40 mg shd nt be given the highe 80 mg dse f simvastatin; instead, they shd be paed n an atenative D- weing teatment(s).
The ageny is emmending that simvastatin 80 mg be sed ny in patients wh have been taking this dse f 12 mnths me and have nt expeiened any mse txiity. It shd nt be pesibed t new patients. Thee ae as new ntaindiatins and dse imitatins f when simvastatin is taken with etain the mediatins.
The hanges t the abe f simvastatin-ntaining mediatins ae based n the FDA's eview f the ests f the seven-yea Stdy f the Effetiveness f Additina edtins in heste and Hmysteine inia tia, the inia tia data, and anayses f advese events sbmitted t the FDA's Advese Event epting System. A shwed that patients taking simvastatin 80 mg daiy had an ineased isk f mse injy mpaed t patients taking we dses f simvastatin the statin dgs. The isk f mse injy is highest ding the fist yea f teatment with the 80 mg dse f simvastatin, is ften the est f inteatins with etain the mediines, and is feqenty assiated with a geneti pedispsitin f simvastatin-eated mse injy.
Simvastatin is sd nde the band-name Z and as a singe-ingedient genei pdt. It is as sd in mbinatin with ezetimibe as Vytin and in mbinatin with Niain as Sim.
The FDA has evised the dg abes f simvastatin and Vytin t inde the new 80 mg dsing estitins. The ageny as evised the abes f simvastatin, Vytin and Sim t inde new dsing emmendatins when these dgs ae sed with etain mediatins that inteat t inease the eve f simvastatin in the bdy, whih an inease the isk f mypathy. Patients wh ae nabe t adeqatey we thei eve f D- n simvastatin 40 mg shd nt be given the highe 80 mg dse f simvastatin; instead, they shd be paed n an atenative D- weing teatment(s).