Guest guest Posted February 28, 2008 Report Share Posted February 28, 2008 Tysabri (natalizumab) http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri [Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. ------------------------------------------------------------------------- Tysabri May Lead to Liver Injury Within a Week After First Dose Signs of hepatic injury may emerge as early as 6 days after starting Tysabri (natalizumab), an integrin receptor antagonist approved for treatment of multiple sclerosis and Crohn disease, the FDA and manufacturer have warned. Such signs include elevated liver enzymes and total bilirubin. According to the drug's updated prescribing information, " the combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant. " The new label advises clinicians to warn patients about the potential risk and to discontinue the drug in those with signs of significant hepatic injury, including jaundice. _________________________________________________________________ Climb to the top of the charts! Play the word scramble challenge with star power. http://club.live.com/star_shuffle.aspx?icid=starshuffle_wlmailtextlink_jan Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 28, 2008 Report Share Posted February 28, 2008 Tysabri (natalizumab) http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri [Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. ------------------------------------------------------------------------- Tysabri May Lead to Liver Injury Within a Week After First Dose Signs of hepatic injury may emerge as early as 6 days after starting Tysabri (natalizumab), an integrin receptor antagonist approved for treatment of multiple sclerosis and Crohn disease, the FDA and manufacturer have warned. Such signs include elevated liver enzymes and total bilirubin. According to the drug's updated prescribing information, " the combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant. " The new label advises clinicians to warn patients about the potential risk and to discontinue the drug in those with signs of significant hepatic injury, including jaundice. _________________________________________________________________ Climb to the top of the charts! Play the word scramble challenge with star power. http://club.live.com/star_shuffle.aspx?icid=starshuffle_wlmailtextlink_jan Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 28, 2008 Report Share Posted February 28, 2008 Tysabri (natalizumab) http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri [Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. ------------------------------------------------------------------------- Tysabri May Lead to Liver Injury Within a Week After First Dose Signs of hepatic injury may emerge as early as 6 days after starting Tysabri (natalizumab), an integrin receptor antagonist approved for treatment of multiple sclerosis and Crohn disease, the FDA and manufacturer have warned. Such signs include elevated liver enzymes and total bilirubin. According to the drug's updated prescribing information, " the combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant. " The new label advises clinicians to warn patients about the potential risk and to discontinue the drug in those with signs of significant hepatic injury, including jaundice. _________________________________________________________________ Climb to the top of the charts! Play the word scramble challenge with star power. http://club.live.com/star_shuffle.aspx?icid=starshuffle_wlmailtextlink_jan Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 28, 2008 Report Share Posted February 28, 2008 Tysabri (natalizumab) http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri [Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. ------------------------------------------------------------------------- Tysabri May Lead to Liver Injury Within a Week After First Dose Signs of hepatic injury may emerge as early as 6 days after starting Tysabri (natalizumab), an integrin receptor antagonist approved for treatment of multiple sclerosis and Crohn disease, the FDA and manufacturer have warned. Such signs include elevated liver enzymes and total bilirubin. According to the drug's updated prescribing information, " the combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant. " The new label advises clinicians to warn patients about the potential risk and to discontinue the drug in those with signs of significant hepatic injury, including jaundice. _________________________________________________________________ Climb to the top of the charts! Play the word scramble challenge with star power. http://club.live.com/star_shuffle.aspx?icid=starshuffle_wlmailtextlink_jan Quote Link to comment Share on other sites More sharing options...
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