| Remicade Side Effects Warnings, and Therapeutic Uses |
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research,
noted that 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," he said. "We believe that the potential benefits of
this product outweigh the risks that are known and have been carefully evaluated."
Study
The safety and effectiveness of Remicade in pediatric Crohn's disease were
assessed in a randomized study in 112 children who were 6 to 17 years old with
moderately to severely active Crohn's disease who had an inadequate response to
conventional therapies. The proportion of these patients who achieved clinical
response compared favorably with the proportion of adults in an earlier Remicade
study in adult Crohn's disease, and the pediatric trial's results showed no new safety
concerns not already expressed in the product's current label.
Side Effects and Risk Factors of Remicade
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.
FDA continues to actively and carefully monitor the safety experience with Remicade
and similar therapies in an effort to maximize their very real benefits yet limit, to the
degree possible, the potential for very serious toxicities. [1]
What is Crohn's disease?
Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that
affects adults and children, males and females alike, and can occur anywhere from
the mouth to the anus. The inflammation that occurs often involves the entire wall of
the gastrointestinal tract which can result in abdominal pain, gastrointestinal
bleeding, diarrhea or loose stools, strictures (blockages), and infections. The
majority of patients with Crohn's disease often require surgery to remove very
inflamed or scarred portions of the gastrointestinal tract. Despite surgery, the
disease often recurs; over time, repeated surgeries may be required. Multiple
surgeries can result in patients becoming debilitated for the rest of their lives and
having to live with chronic diarrhea and requiring supplemental nutrition. [2]
Available treatments for Crohn's disease are primarily directed at reducing the
amount of inflammation in the gastrointestinal tract. The cause of CrohnÂ’s disease
is unknown and there is currently no known cure for it. Remicade does not cure
CrohnÂ’s disease but may reduce gastrointestinal inflammation by acting against
TNF-alpha. [2]
What is Remicade?
Remicade is a biotechnology product and is also known as infliximab. 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). This antibody is manufactured
using cells containing human and mouse antibody genes. 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.
Recently, Remicade (infliximab) is being approved to treat children with CrohnÂ’s
disease who have moderately to severely active CrohnÂ’s disease despite being on
traditional or conventional therapies such as aminosalicylates, steroids, and
immunomodulator drugs (e.g., azathioprine and 6-mercaptopurine). [2]
As part of the initial approval of Remicade in 1998 for adult patients with CrohnÂ’s
disease, Centocor committed to study Remicade in children with CrohnÂ’s disease.
Remicade has not been studied in children with CrohnÂ’s disease who are under the
age of 6 years. The safety and effectiveness of Remicade in pediatric CrohnÂ’s
disease patients less than 6 years old have not been established in clinical trials.
Should Remicade be used in everyone with Crohn's disease?
No. Remicade is currently approved for adults and children with Crohn]s disease
who continue to have very active symptoms of CrohnÂ’s disease despite having
been tried on more conventional therapies (listed above). Remicade should be
prescribed by physicians who are experienced in treating patients with CrohnÂ’s
disease and who feel that the benefits of Remicade therapy outweigh the risks
associated with this treatment.
What are the adverse events that have been associated with Remicade therapy?
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 side effects that can occur with Remicade therapy 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 events 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.
Does the May 17, 2006 JAMA article raise new safety concerns about Remicade?
The risks of side effects such as malignancy and serious infection that were
described in the JAMA article have been known and are labeled for all approved
TNF-alpha blocking agents, including Remicade.
[1] FDA Approves Remicade for Children with CrohnÂ’s Disease FDA News May 19,
2006 [2] Questions and Answers on Remicade/FDA Action May 19, 2006
noted that 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," he said. "We believe that the potential benefits of
this product outweigh the risks that are known and have been carefully evaluated."
Study
The safety and effectiveness of Remicade in pediatric Crohn's disease were
assessed in a randomized study in 112 children who were 6 to 17 years old with
moderately to severely active Crohn's disease who had an inadequate response to
conventional therapies. The proportion of these patients who achieved clinical
response compared favorably with the proportion of adults in an earlier Remicade
study in adult Crohn's disease, and the pediatric trial's results showed no new safety
concerns not already expressed in the product's current label.
Side Effects and Risk Factors of Remicade
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.
FDA continues to actively and carefully monitor the safety experience with Remicade
and similar therapies in an effort to maximize their very real benefits yet limit, to the
degree possible, the potential for very serious toxicities. [1]
What is Crohn's disease?
Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that
affects adults and children, males and females alike, and can occur anywhere from
the mouth to the anus. The inflammation that occurs often involves the entire wall of
the gastrointestinal tract which can result in abdominal pain, gastrointestinal
bleeding, diarrhea or loose stools, strictures (blockages), and infections. The
majority of patients with Crohn's disease often require surgery to remove very
inflamed or scarred portions of the gastrointestinal tract. Despite surgery, the
disease often recurs; over time, repeated surgeries may be required. Multiple
surgeries can result in patients becoming debilitated for the rest of their lives and
having to live with chronic diarrhea and requiring supplemental nutrition. [2]
Available treatments for Crohn's disease are primarily directed at reducing the
amount of inflammation in the gastrointestinal tract. The cause of CrohnÂ’s disease
is unknown and there is currently no known cure for it. Remicade does not cure
CrohnÂ’s disease but may reduce gastrointestinal inflammation by acting against
TNF-alpha. [2]
What is Remicade?
Remicade is a biotechnology product and is also known as infliximab. 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). This antibody is manufactured
using cells containing human and mouse antibody genes. 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.
Recently, Remicade (infliximab) is being approved to treat children with CrohnÂ’s
disease who have moderately to severely active CrohnÂ’s disease despite being on
traditional or conventional therapies such as aminosalicylates, steroids, and
immunomodulator drugs (e.g., azathioprine and 6-mercaptopurine). [2]
As part of the initial approval of Remicade in 1998 for adult patients with CrohnÂ’s
disease, Centocor committed to study Remicade in children with CrohnÂ’s disease.
Remicade has not been studied in children with CrohnÂ’s disease who are under the
age of 6 years. The safety and effectiveness of Remicade in pediatric CrohnÂ’s
disease patients less than 6 years old have not been established in clinical trials.
Should Remicade be used in everyone with Crohn's disease?
No. Remicade is currently approved for adults and children with Crohn]s disease
who continue to have very active symptoms of CrohnÂ’s disease despite having
been tried on more conventional therapies (listed above). Remicade should be
prescribed by physicians who are experienced in treating patients with CrohnÂ’s
disease and who feel that the benefits of Remicade therapy outweigh the risks
associated with this treatment.
What are the adverse events that have been associated with Remicade therapy?
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 side effects that can occur with Remicade therapy 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 events 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.
Does the May 17, 2006 JAMA article raise new safety concerns about Remicade?
The risks of side effects such as malignancy and serious infection that were
described in the JAMA article have been known and are labeled for all approved
TNF-alpha blocking agents, including Remicade.
[1] FDA Approves Remicade for Children with CrohnÂ’s Disease FDA News May 19,
2006 [2] Questions and Answers on Remicade/FDA Action May 19, 2006
| 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. 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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THIS WEBSITE TALKS ABOUT THE SIDE EFFECTS AND THE POTENTIAL HEALTH BENEFITS OF HERBS, SUPPLEMENTS,
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FORMS OF PUBLICATIONS. Privacy Policy. ARTICLE INDEX
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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