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A small number of patients using infliximab (Remicade) have had very severe hepatic reactions, according to a revision of the package prescribing information.
In announcing the new safety information, the Food and Drug Administration and Centocor Inc. said there have been 35 cases of severe hepatic reactions in patients using infliximab reported in postmarketing data and 3 cases reported in clinical trials.
The reactions have included acute liver failure, jaundice, hepatitis, and cholestasis. Some cases were fatal or resulted in liver transplantation. They occurred from 2 weeks after starting therapy to more than a year after initiation. A causal relationship with infliximab has not been established, but treatment with the biologic can induce autoantibodies and autoimmune hepatitis has been diagnosed in some of the cases.
According to the warning, patients with signs of liver dysfunction should be evaluated. If jaundice or elevations in liver enzymes (greater than 5 times the upper limit of normal) occur, the biologic should be stopped and an investigation undertaken.
In clinical trials, mild to moderate elevations in liver enzymes were noted, without progression to severe hepatic injury.
In addition to the hepatic-reaction warning, Centocor added a warning that patients receiving infliximab may be at an increased risk of developing pneumonia, based on data from clinical trials data in rheumatoid arthritis patients.
Infliximab is approved for rheumatoid arthritis and Crohn's disease; in December, it was approved for ankylosing spondylitis.
A small number of patients using infliximab (Remicade) have had very severe hepatic reactions, according to a revision of the package prescribing information.
In announcing the new safety information, the Food and Drug Administration and Centocor Inc. said there have been 35 cases of severe hepatic reactions in patients using infliximab reported in postmarketing data and 3 cases reported in clinical trials.
The reactions have included acute liver failure, jaundice, hepatitis, and cholestasis. Some cases were fatal or resulted in liver transplantation. They occurred from 2 weeks after starting therapy to more than a year after initiation. A causal relationship with infliximab has not been established, but treatment with the biologic can induce autoantibodies and autoimmune hepatitis has been diagnosed in some of the cases.
According to the warning, patients with signs of liver dysfunction should be evaluated. If jaundice or elevations in liver enzymes (greater than 5 times the upper limit of normal) occur, the biologic should be stopped and an investigation undertaken.
In clinical trials, mild to moderate elevations in liver enzymes were noted, without progression to severe hepatic injury.
In addition to the hepatic-reaction warning, Centocor added a warning that patients receiving infliximab may be at an increased risk of developing pneumonia, based on data from clinical trials data in rheumatoid arthritis patients.
Infliximab is approved for rheumatoid arthritis and Crohn's disease; in December, it was approved for ankylosing spondylitis.
A small number of patients using infliximab (Remicade) have had very severe hepatic reactions, according to a revision of the package prescribing information.
In announcing the new safety information, the Food and Drug Administration and Centocor Inc. said there have been 35 cases of severe hepatic reactions in patients using infliximab reported in postmarketing data and 3 cases reported in clinical trials.
The reactions have included acute liver failure, jaundice, hepatitis, and cholestasis. Some cases were fatal or resulted in liver transplantation. They occurred from 2 weeks after starting therapy to more than a year after initiation. A causal relationship with infliximab has not been established, but treatment with the biologic can induce autoantibodies and autoimmune hepatitis has been diagnosed in some of the cases.
According to the warning, patients with signs of liver dysfunction should be evaluated. If jaundice or elevations in liver enzymes (greater than 5 times the upper limit of normal) occur, the biologic should be stopped and an investigation undertaken.
In clinical trials, mild to moderate elevations in liver enzymes were noted, without progression to severe hepatic injury.
In addition to the hepatic-reaction warning, Centocor added a warning that patients receiving infliximab may be at an increased risk of developing pneumonia, based on data from clinical trials data in rheumatoid arthritis patients.
Infliximab is approved for rheumatoid arthritis and Crohn's disease; in December, it was approved for ankylosing spondylitis.