| Remicade Side Effects September 2011 Warnings, and Therapeutic Uses |
About Crohn's disease
There have been no satisfactory treatments for children with Crohn's disease who have moderate to severe disease
activity despite traditional or conventional therapies. Crohn's disease can cause diarrhea, cramping, abdominal pain,
gastrointestinal bleeding, and in some cases creates abnormal connections (fistulas) leading from the intestine to the
skin. Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and
maintaining disease remission in children who have no other safe and effective therapy, according to FDA.
About ulcerative colitis
UC is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum.
Symptoms of UC include abdominal pain, diarrhea, rectal bleeding, weight loss and fever. Remicade reduces signs and
symptoms of UC and induces and maintains clinical remission in these patients.
________________________________________________________________________________________
Remicade
Remicade is a biotechnology product and is also known as infliximab. This antibody is manufactured using cells
containing human and mouse antibody genes. It was recommended for approval for the treatment of adult Crohn's
disease by the Gastrointestinal Drugs Advisory Committee in May 1998 and licensed in August 1998. It is a genetically
engineered monoclonal antibody that binds to a protein called tumor necrosis factor-alpha (TNF-alpha). TNF blockers
suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and
lead to autoimmune diseases. Tumor necrosis factor-alpha plays a key role in the chronic inflammation that occurs in
Crohn's disease and in other diseases that are characterized by chronic inflammation such as rheumatoid arthritis,
psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
In addition to being approved for UC, Remicade is approved for the treatment of other autoimmune diseases such as
Crohn’s disease in adults and children 6 years and older, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis
affecting the joints in the spine and the pelvis), psoriatic arthritis (joint pain associated with psoriasis), and plaque
psoriasis in adults.
Recently, Remicade (infliximab) is being approved to treat children with Crohn’s disease who have moderately to
severely active Crohn’s disease despite being on traditional or conventional therapies such as aminosalicylates,
steroids, and immunomodulator drugs (e.g., azathioprine and 6-mercaptopurine). [2]
___________________________________________________________________________________
Remicade Side Effects, Risk and Danger
In general, the safety profile for Remicade in the pediatric trial was similar to the data that was presented at an FDA
Arthritis Advisory Committee meeting in March 2003, and that dealt with the extent to which anti-TNF therapies may
increase the risk of serious infections and malignancies, such as sepsis and pneumonia in certain patients.
These risks, which are described in a study in the May 17 issue of the Journal of the American Medical Association, are
included in the current labels for all approved TNF-alpha blocking agents, including Remicade.
More recently, the FDA has received rare post-marketing reports of an aggressive and often fatal type of T-cell
lymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with the Crohn's disease. In most,
but not all cases, these patients were treated with standard immunosuppressive therapies (azathioprine or 6-
mercaptopurine) in combination with Remicade. The FDA is working with the manufacturer to address this risk by
updating the Warnings sections of the Remicade label. [1]
___________________________________________________________________________________
Remicade Side Effects in Details
Data from clinical trials and post-marketing reports have identified serious adverse events associated with Remicade
therapy and these adverse events appear to be related to the effects of the drug. Serious infections, including
tuberculosis and opportunistic infections, have been reported. Some of these infections have been fatal.
In clinical trials evaluating the use of Remicade in rheumatoid arthritis and adult CrohnÂ’s disease, there have been
more reports of malignancies including a type of malignancy called lymphoma in patients receiving Remicade compared
to those receiving placebo.
These risks of malignancy and serious infection have been described in Remicade labeling, and were also the subject of
an FDA Arthritis Advisory Committee meeting in March, 2003
Other Remicade side effects include allergic or infusion reactions, liver injury, worsening of heart failure, hematologic
events, hypersensitivity reactions, and neurologic events.
Physicians who are considering Remicade therapy for their patients should inform them of the potential adverse side
effects that have been reported in clinical trials and in post-marketing safety reports.
Are there any safety concerns specific to Crohn's disease patients who use Remicade?
Analysis of the post-marketing safety database by the FDA identified rare cases of an aggressive, often fatal form of
lymphoma called hepatosplenic T-cell lymphoma in adolescent and young adult patients with CrohnÂ’s disease who
were treated with Remicade. These patients also had a history of being treated with the immunomodulator drug called
azathioprine. Some of these patients were only on azathioprine alone. No cases of hepatosplenic T-cell lymphoma
have been identified in patients receiving Remicade alone. The recent identification of this type of lymphoma resulted in
modification to the “boxed warning” and “warnings” sections of the Remicade label to highlight this aggressive form of
lymphoma. The potential role of Remicade in the development of malignancies is not known. In addition to these
changes to product labeling, the Remicade sponsor has agreed to conduct long-term follow-up of pediatric patients with
Crohn's disease to monitor for this rare form of lymphoma and for other adverse events.
FDA ALERTS WARNINGS
[9-07-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Boxed Warning
for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection
from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions
sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about
the risk for serious infections and the associated disease-causing pathogens. [4]
* FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include
warnings about infection with Legionella and Listeria bacteria1
9/7/2011
* FDA Drug Safety Podcast for Healthcare Professionals: Safety Review update on reports of Hepatosplenic T-Cell
Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or
mercaptopurine2
4/18/2011
* FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents
and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine3
4/14/2011
* Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel,
Humira, Cimzia, and Simponi)4
8/4/2009
* Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF)
Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)5
8/4/2009
* FDA: Cancer Warnings Required for TNF Blockers6
8/4/2009
* Information for Healthcare Professionals: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and
Remicade (infliximab)7
FDA ALERT [9/4/2008]
* Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as
Remicade, Enbrel, Humira, and Cimzia)8
6/4/2008
[1] FDA Approves Remicade for Children with Crohn’s Disease FDA News May 19, 2006 [2] Questions and Answers on
Remicade/FDA Action May 19, 2006 [3] FDA approves Remicade to treat ulcerative colitis in children 6 years and older
FDA News Sept. 23, 2011, [4] FDA Safety Announcement 9-07-2011
There have been no satisfactory treatments for children with Crohn's disease who have moderate to severe disease
activity despite traditional or conventional therapies. Crohn's disease can cause diarrhea, cramping, abdominal pain,
gastrointestinal bleeding, and in some cases creates abnormal connections (fistulas) leading from the intestine to the
skin. Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and
maintaining disease remission in children who have no other safe and effective therapy, according to FDA.
About ulcerative colitis
UC is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum.
Symptoms of UC include abdominal pain, diarrhea, rectal bleeding, weight loss and fever. Remicade reduces signs and
symptoms of UC and induces and maintains clinical remission in these patients.
________________________________________________________________________________________
Remicade
Remicade is a biotechnology product and is also known as infliximab. This antibody is manufactured using cells
containing human and mouse antibody genes. It was recommended for approval for the treatment of adult Crohn's
disease by the Gastrointestinal Drugs Advisory Committee in May 1998 and licensed in August 1998. It is a genetically
engineered monoclonal antibody that binds to a protein called tumor necrosis factor-alpha (TNF-alpha). TNF blockers
suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and
lead to autoimmune diseases. Tumor necrosis factor-alpha plays a key role in the chronic inflammation that occurs in
Crohn's disease and in other diseases that are characterized by chronic inflammation such as rheumatoid arthritis,
psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
In addition to being approved for UC, Remicade is approved for the treatment of other autoimmune diseases such as
Crohn’s disease in adults and children 6 years and older, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis
affecting the joints in the spine and the pelvis), psoriatic arthritis (joint pain associated with psoriasis), and plaque
psoriasis in adults.
Recently, Remicade (infliximab) is being approved to treat children with Crohn’s disease who have moderately to
severely active Crohn’s disease despite being on traditional or conventional therapies such as aminosalicylates,
steroids, and immunomodulator drugs (e.g., azathioprine and 6-mercaptopurine). [2]
___________________________________________________________________________________
Remicade Side Effects, Risk and Danger
In general, the safety profile for Remicade in the pediatric trial was similar to the data that was presented at an FDA
Arthritis Advisory Committee meeting in March 2003, and that dealt with the extent to which anti-TNF therapies may
increase the risk of serious infections and malignancies, such as sepsis and pneumonia in certain patients.
These risks, which are described in a study in the May 17 issue of the Journal of the American Medical Association, are
included in the current labels for all approved TNF-alpha blocking agents, including Remicade.
More recently, the FDA has received rare post-marketing reports of an aggressive and often fatal type of T-cell
lymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with the Crohn's disease. In most,
but not all cases, these patients were treated with standard immunosuppressive therapies (azathioprine or 6-
mercaptopurine) in combination with Remicade. The FDA is working with the manufacturer to address this risk by
updating the Warnings sections of the Remicade label. [1]
___________________________________________________________________________________
Remicade Side Effects in Details
Data from clinical trials and post-marketing reports have identified serious adverse events associated with Remicade
therapy and these adverse events appear to be related to the effects of the drug. Serious infections, including
tuberculosis and opportunistic infections, have been reported. Some of these infections have been fatal.
In clinical trials evaluating the use of Remicade in rheumatoid arthritis and adult CrohnÂ’s disease, there have been
more reports of malignancies including a type of malignancy called lymphoma in patients receiving Remicade compared
to those receiving placebo.
These risks of malignancy and serious infection have been described in Remicade labeling, and were also the subject of
an FDA Arthritis Advisory Committee meeting in March, 2003
Other Remicade side effects include allergic or infusion reactions, liver injury, worsening of heart failure, hematologic
events, hypersensitivity reactions, and neurologic events.
Physicians who are considering Remicade therapy for their patients should inform them of the potential adverse side
effects that have been reported in clinical trials and in post-marketing safety reports.
Are there any safety concerns specific to Crohn's disease patients who use Remicade?
Analysis of the post-marketing safety database by the FDA identified rare cases of an aggressive, often fatal form of
lymphoma called hepatosplenic T-cell lymphoma in adolescent and young adult patients with CrohnÂ’s disease who
were treated with Remicade. These patients also had a history of being treated with the immunomodulator drug called
azathioprine. Some of these patients were only on azathioprine alone. No cases of hepatosplenic T-cell lymphoma
have been identified in patients receiving Remicade alone. The recent identification of this type of lymphoma resulted in
modification to the “boxed warning” and “warnings” sections of the Remicade label to highlight this aggressive form of
lymphoma. The potential role of Remicade in the development of malignancies is not known. In addition to these
changes to product labeling, the Remicade sponsor has agreed to conduct long-term follow-up of pediatric patients with
Crohn's disease to monitor for this rare form of lymphoma and for other adverse events.
FDA ALERTS WARNINGS
[9-07-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Boxed Warning
for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection
from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions
sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about
the risk for serious infections and the associated disease-causing pathogens. [4]
* FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include
warnings about infection with Legionella and Listeria bacteria1
9/7/2011
* FDA Drug Safety Podcast for Healthcare Professionals: Safety Review update on reports of Hepatosplenic T-Cell
Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or
mercaptopurine2
4/18/2011
* FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents
and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine3
4/14/2011
* Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel,
Humira, Cimzia, and Simponi)4
8/4/2009
* Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF)
Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)5
8/4/2009
* FDA: Cancer Warnings Required for TNF Blockers6
8/4/2009
* Information for Healthcare Professionals: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and
Remicade (infliximab)7
FDA ALERT [9/4/2008]
* Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as
Remicade, Enbrel, Humira, and Cimzia)8
6/4/2008
[1] FDA Approves Remicade for Children with Crohn’s Disease FDA News May 19, 2006 [2] Questions and Answers on
Remicade/FDA Action May 19, 2006 [3] FDA approves Remicade to treat ulcerative colitis in children 6 years and older
FDA News Sept. 23, 2011, [4] FDA Safety Announcement 9-07-2011
| Abstract The Food and Drug Administration approved Remicade (infliximab) to treat children with active Crohn's disease, a chronic, inflammatory condition of the bowel that can be severely debilitating. On Sept. 23, 2011, FDA further approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy. Remicade is a genetically engineered monoclonal antibody, which reduces inflammation (swelling/redness) by blocking the action of tumor necrosis factor-alpha (TNF-alpha), that was initially approved in 1998 to treat Crohn's disease in adults. _________________________________________________________________________________________ |
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PHYTONUTRIENTS AND DRUG PRODUCTS. THIS WEBSITE ALSO TALKS ABOUT SOME POPULAR HEALTH ISSUES AND DISEASES.
ARTICLES IN THIS WEB SITE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, YOU SHOULD CONSULT WITH YOUR
DOCTOR IMMEDIATELY. ALL RIGHTS RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS. Privacy Policy. ARTICLE INDEX
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