Jump to content
RemedySpot.com

Tysabri May Lead to Liver Injury Within a Week After First Dose

Rate this topic


Guest guest

Recommended Posts

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

Link to comment
Share on other sites

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

Link to comment
Share on other sites

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

Link to comment
Share on other sites

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

Link to comment
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...