Preliminary guide to IBD marketing websites.
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| Company |
Drug |
Non-profit |
Marketing Website |
Clinical Trial Recruitment |
|
|
|
Warnings
|
|
|
Abbott Laboratories manufactures
Humira
Abbott Laboratories contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Humira
Abbott Laboratories owns
www.crohnsonline.com which markets
Humira
Humira's "black box warning, as it appears in the physician prescribing literature.
WARNING: RISK OF SERIOUS INFECTIONS
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation),
invasive fungal infections, and other opportunistic infections, have been observed in
patients receiving HUMIRA. Some of these infections have been fatal. Anti-
tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of
reactivation in patients receiving treatment with HUMIRA. However, active
tuberculosis has developed in patients receiving HUMIRA whose screening for latent
tuberculosis infection was negative.
Patients should be evaluated for tuberculosis risk factors and be tested for latent
tuberculosis infection prior to initiating HUMIRA and during therapy. Treatment of
latent tuberculosis infection should be initiated prior to therapy with HUMIRA.
Physicians should monitor patients receiving HUMIRA for signs and symptoms of
active tuberculosis, including patients who tested negative for latent tuberculosis
infection. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
Proctor & Gamble Pharmaceuticals manufactures Asacol
Proctor & Gamble Pharmaceuticals contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America promotes Asacol
The Crohn's & Colitis Foundation of America assists Proctor & Gamble Pharmaceuticals in recruiting patients for clinical studies.
Proctor & Gamble Pharmaceuticals owns www.living-better.com which markets Asacol
Proctor & Gamble Pharmaceuticals owns www.ascenducstudy.com which recruits people for clinical trials.
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
UCB Global Pharma manufactures Cimzia
UCB Global Pharma contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists UCB Global Pharma in recruiting patients for clinical studies.
UCB Global Pharma owns www.crohnsandme.com which markets Cimzia
Abbott Laboratories manufactures
Humira
Abbott Laboratories contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Humira
Abbott Laboratories owns
www.crohnsonline.com which markets
Humira
Humira's "black box warning, as it appears in the physician prescribing literature.
WARNING: RISK OF SERIOUS INFECTIONS
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation),
invasive fungal infections, and other opportunistic infections, have been observed in
patients receiving HUMIRA. Some of these infections have been fatal. Anti-
tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of
reactivation in patients receiving treatment with HUMIRA. However, active
tuberculosis has developed in patients receiving HUMIRA whose screening for latent
tuberculosis infection was negative.
Patients should be evaluated for tuberculosis risk factors and be tested for latent
tuberculosis infection prior to initiating HUMIRA and during therapy. Treatment of
latent tuberculosis infection should be initiated prior to therapy with HUMIRA.
Physicians should monitor patients receiving HUMIRA for signs and symptoms of
active tuberculosis, including patients who tested negative for latent tuberculosis
infection. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Proctor & Gamble Pharmaceuticals manufactures
Asacol
Proctor & Gamble Pharmaceuticals contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Asacol
The
Crohn's & Colitis Foundation of America assists
Proctor & Gamble Pharmaceuticals in recruiting patients for clinical studies.
Proctor & Gamble Pharmaceuticals owns
www.living-better.com which markets
Asacol
Proctor & Gamble Pharmaceuticals owns
www.ascenducstudy.com which recruits people for clinical trials.
Shire manufactures
Pentasa
Shire contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America assists
Shire in recruiting patients for clinical studies.
Shire owns
www.managinguc.com which markets
Pentasa
UCB Global Pharma manufactures
Cimzia
UCB Global Pharma contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America assists
UCB Global Pharma in recruiting patients for clinical studies.
UCB Global Pharma owns
www.crohnsandme.com which markets
Cimzia
The
FDA Black Box Warning is designed to highlight special problems, particularly those that are serious, and to give health care professionals a clear understanding of a potential medical complication associated with a drug.
TNF blocking agents such as Humira, Remicade, Cimzia, and Nuvion carry similar risks regarding serious, possibly fatal, infections. The serious side effects of Humira and Remicade are well established. To inform physicians using these drugs, the "black box" warnings below are required at the top of the prescribing literature. Cimzia and Nuvion are still undergoing testing.
Humira's "black box warning", as it appears in the physician prescribing literature:
WARNING: RISK OF SERIOUS INFECTIONS
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation),
invasive fungal infections, and other opportunistic infections, have been observed in
patients receiving HUMIRA. Some of these infections have been fatal. Anti-
tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of
reactivation in patients receiving treatment with HUMIRA. However, active
tuberculosis has developed in patients receiving HUMIRA whose screening for latent
tuberculosis infection was negative.
Patients should be evaluated for tuberculosis risk factors and be tested for latent
tuberculosis infection prior to initiating HUMIRA and during therapy. Treatment of
latent tuberculosis infection should be initiated prior to therapy with HUMIRA.
Physicians should monitor patients receiving HUMIRA for signs and symptoms of
active tuberculosis, including patients who tested negative for latent tuberculosis
infection. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
Remicade's "black box warning", as it appears in the physician prescribing literature:
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Abbott Laboratories manufactures
Humira
Abbott Laboratories contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Humira
Abbott Laboratories owns
www.crohnsonline.com which markets
Humira
Humira's "black box warning, as it appears in the physician prescribing literature.
WARNING: RISK OF SERIOUS INFECTIONS
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation),
invasive fungal infections, and other opportunistic infections, have been observed in
patients receiving HUMIRA. Some of these infections have been fatal. Anti-
tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of
reactivation in patients receiving treatment with HUMIRA. However, active
tuberculosis has developed in patients receiving HUMIRA whose screening for latent
tuberculosis infection was negative.
Patients should be evaluated for tuberculosis risk factors and be tested for latent
tuberculosis infection prior to initiating HUMIRA and during therapy. Treatment of
latent tuberculosis infection should be initiated prior to therapy with HUMIRA.
Physicians should monitor patients receiving HUMIRA for signs and symptoms of
active tuberculosis, including patients who tested negative for latent tuberculosis
infection. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
PDL BioPharma manufactures Nuvion
PDL BioPharma contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists PDL BioPharma in recruiting patients for clinical studies.
PDL BioPharma owns www.restoretrial.com which recruits patients for clinical trials.
Because it is a TNF-blocking agent, if approved by the FDA, Nuvion will likely receive a FDA Black Box Warning
PDL BioPharma manufactures Nuvion
PDL BioPharma contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists PDL BioPharma in recruiting patients for clinical studies.
PDL BioPharma owns www.restoretrial.com which recruits patients for clinical trials.
Because it is a TNF-blocking agent, if approved by the FDA, Nuvion will likely receive a FDA Black Box Warning
Shire manufactures Pentasa
Shire contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists Shire in recruiting patients for clinical studies.
Shire owns www.managinguc.com which markets Pentasa
Proctor & Gamble Pharmaceuticals manufactures Asacol
Proctor & Gamble Pharmaceuticals contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America promotes Asacol
The Crohn's & Colitis Foundation of America assists Proctor & Gamble Pharmaceuticals in recruiting patients for clinical studies.
Proctor & Gamble Pharmaceuticals owns www.living-better.com which markets Asacol
Proctor & Gamble Pharmaceuticals owns www.ascenducstudy.com which recruits people for clinical trials.
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Shire manufactures Pentasa
Shire contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists Shire in recruiting patients for clinical studies.
Shire owns www.managinguc.com which markets Pentasa
UCB Global Pharma manufactures Cimzia
UCB Global Pharma contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists UCB Global Pharma in recruiting patients for clinical studies.
UCB Global Pharma owns www.crohnsandme.com which markets Cimzia
Proctor & Gamble Pharmaceuticals manufactures Asacol
Proctor & Gamble Pharmaceuticals contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America promotes Asacol
The Crohn's & Colitis Foundation of America assists Proctor & Gamble Pharmaceuticals in recruiting patients for clinical studies.
Proctor & Gamble Pharmaceuticals owns www.living-better.com which markets Asacol
Proctor & Gamble Pharmaceuticals owns www.ascenducstudy.com which recruits people for clinical trials.
UCB Global Pharma manufactures Cimzia
UCB Global Pharma contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists UCB Global Pharma in recruiting patients for clinical studies.
UCB Global Pharma owns www.crohnsandme.com which markets Cimzia
Abbott Laboratories manufactures
Humira
Abbott Laboratories contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Humira
Abbott Laboratories owns
www.crohnsonline.com which markets
Humira
Humira's "black box warning, as it appears in the physician prescribing literature.
WARNING: RISK OF SERIOUS INFECTIONS
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation),
invasive fungal infections, and other opportunistic infections, have been observed in
patients receiving HUMIRA. Some of these infections have been fatal. Anti-
tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of
reactivation in patients receiving treatment with HUMIRA. However, active
tuberculosis has developed in patients receiving HUMIRA whose screening for latent
tuberculosis infection was negative.
Patients should be evaluated for tuberculosis risk factors and be tested for latent
tuberculosis infection prior to initiating HUMIRA and during therapy. Treatment of
latent tuberculosis infection should be initiated prior to therapy with HUMIRA.
Physicians should monitor patients receiving HUMIRA for signs and symptoms of
active tuberculosis, including patients who tested negative for latent tuberculosis
infection. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Proctor & Gamble Pharmaceuticals manufactures Asacol
Proctor & Gamble Pharmaceuticals contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America promotes Asacol
The Crohn's & Colitis Foundation of America assists Proctor & Gamble Pharmaceuticals in recruiting patients for clinical studies.
Proctor & Gamble Pharmaceuticals owns www.living-better.com which markets Asacol
Proctor & Gamble Pharmaceuticals owns www.ascenducstudy.com which recruits people for clinical trials.
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.
Shire manufactures Pentasa
Shire contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists Shire in recruiting patients for clinical studies.
Shire owns www.managinguc.com which markets Pentasa
PDL BioPharma manufactures Nuvion
PDL BioPharma contributes funding to the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America assists PDL BioPharma in recruiting patients for clinical studies.
PDL BioPharma owns www.restoretrial.com which recruits patients for clinical trials.
Because it is a TNF-blocking agent, if approved by the FDA, Nuvion will likely receive a FDA Black Box Warning
Centocor manufactures
Remicade
Johnson & Johnson owns
Centocor
Centocor contributes funding to the
Crohn's & Colitis Foundation of America
The
Crohn's & Colitis Foundation of America promotes
Remicade
The
Crohn's & Colitis Foundation of America assists
Centocor in recruiting patients for clinical studies.
Centocor owns
www.livingwithuc.com and
www.livingwithcrohnsdisease.com which market
Remicade
Centocor uses
Inclinix to recruit patients for clinical studies.
Inclinix runs the
www.SonicTrial.com website which recruits for a
Remicade and Imuran study.
Inclinix runs the
www.crohnstudy.com website which recruits for a
Remicade and Imuran study.
Remicade's "black box warning, as it appears in the physician prescribing literature.
WARNINGS
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE
WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH A
REACTIVE TUBERCULIN SKIN TEST REDUCES THE RISK OF TB
REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH REMICADE.
HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS
RECEIVING REMICADE WHO WERE TUBERCULIN SKIN TEST NEGATIVE
PRIOR TO RECEIVING REMICADE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.
PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING REMICADE FOR SIGNS
AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE
TUBERCULIN SKIN TEST NEGATIVE.
HEPATOSPLENIC T-CELL LYMPHOMAS
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA
HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH
CROHN'S DISEASE TREATED WITH REMICADE. THIS RARE TYPE OF T-CELL
LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY
FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH
REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT
WITH AZATHIOPRINE OR 6-MERCAPTOPURINE.