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Arthritis in Children Linked to Infections

Posted 1 May 2012 by Drugs.com

TUESDAY, May 1 – Children with juvenile arthritis have higher rates of bacterial infection when hospitalized than children without arthritis, a new study says. While taking high-dose steroids was associated with a higher infection risk among kids with arthritis, other arthritis drugs – methotrexate and tumor necrosis factor alpha (TNF) inhibitors – were not. Researchers analyzed Medicaid data on nearly 8,500 children with juvenile idiopathic arthritis and more than 360,000 arthritis-free children. Idiopathic means that a disease occurs without a known cause. Pharmacy claims were examined to determine arthritis patients' use of drugs that suppress the immune system, including high-dose glucocorticoids (steroids), methotrexate and TNF inhibitors, according to the study published May 1 in the journal Arthritis & Rheumatism. Kids with arthritis who were not currently treated with ... Read more

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

Posted 6 Nov 2011 by Drugs.com

[UPDATED 11/04/2011] Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include: patient characteristics (age, gender, no patient identifiers) risk factors for malignancy exposure to other immune suppressing products or products with risk of malignancy indication for TNF blocker treatment TNF blocker exposure (duration, dose) cancer diagnosis (date of diagnosis, stage) biopsy results outcomes of malignancy (treatments, event outcome) [Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, ... Read more

FDA Medwatch Alert: Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria

Posted 8 Sep 2011 by Drugs.com

including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) ISSUE: FDA notified 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. Patients treated with TNFα blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens. BA ... Read more

Related support groups: Enbrel, Humira, Remicade, Cimzia, Simponi, Etanercept, Adalimumab, Infliximab, Golimumab, Certolizumab

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

Posted 16 Apr 2011 by Drugs.com

[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine. TNF blockers include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab). BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL. Although most reported cases of HSTCL oc ... Read more

TNF Blockers May Help Some With Rheumatoid Arthritis

Posted 16 Dec 2009 by Drugs.com

THURSDAY, Aug. 6 – Patients with early rheumatoid arthritis (RA) who respond poorly to standard treatment with methotrexate may benefit from additional treatment with tumor necrosis factor (TNF) blockers, a Swedish study suggests. Previous research has shown that 20 percent to 40 percent of patients have a good response to methotrexate therapy and don't need more intensive combination treatment. This new study included 487 patients with early RA (less than one year's duration) who were initially treated with methotrexate. After three to four months, the 258 patients with an inadequate response to methotrexate were randomly assigned to receive either the TNF blocker infliximib (Remicade) or the conventional disease-modifying antirheumatic drugs, sulfasalazine and hydroxychloroquine. After 12 months, 39 percent of patients given infliximib achieved a good response, compared with 25 ... Read more

Related support groups: Rheumatoid Arthritis, Enbrel, Humira, Remicade, Cimzia, Etanercept, Infliximab, Adalimumab, Golimumab, Certolizumab

Certain Arthritis, Crohn's Drugs May Raise Kids' Cancer Risk: FDA

Posted 16 Dec 2009 by Drugs.com

TUESDAY, Aug. 4 – Drugs widely used to fight rheumatoid arthritis, Crohn's disease and other inflammatory disorders must now carry an updated "black box" warning label cautioning patients and doctors that the medicines may boost cancer risk in children and adolescents, the U.S. Food and Drug Administration announced Tuesday. The drugs, called tumor necrosis factor (TNF) blockers, work by interrupting a protein that causes inflammation and damage to bones, cartilage and other tissue. They include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab). "FDA announced that it has completed its analysis of TNF blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents," according to FDA spokeswomen Crystal Rice. "This new safety ... Read more

Related support groups: Enbrel, Humira, Remicade, Cimzia, Etanercept, Adalimumab, Infliximab, Golimumab, Certolizumab

Rheumatoid Arthritis Treatment Doesn't Promote Cancer

Posted 1 Dec 2009 by Drugs.com

THURSDAY, Oct. 29 – Treatment with tumor necrosis factor (TNF) blockers doesn't increase rheumatoid arthritis patients' risk of cancer, new research has found. TNF is a substance secreted by immune cells that regulates the immune system and plays a role in inflammation. TNF blockers are immunosuppressants that reduce inflammation in people with rheumatoid arthritis, but concerns have been raised that long-term use of the drugs may increase the risk of infections and cancer. Swedish researchers analyzed data from 6,366 rheumatoid arthritis patients who started anti-TNF therapy with infliximab (Remicade), adalimumab (Humira) or etanercept (Enbrel) between January 1999 and July 2006. The study participants were compared with other groups of rheumatoid arthritis patients, including 61,160 not taking medications, 4,015 taking methotrexate (the gold standard of treatment) and 4,105 taking ... Read more

Related support groups: Rheumatoid Arthritis, Enbrel, Humira, Remicade, Cimzia, Etanercept, Infliximab, Adalimumab, Golimumab, Certolizumab

Cimzia Approved for Rheumatoid Arthritis

Posted 14 May 2009 by Drugs.com

THURSDAY, May 14 – The U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis, Belgian drug maker UCB said Thursday in a news release. The injected drug was approved in April 2008 to treat the inflammatory bowel disorder Crohn's disease. Rheumatoid arthritis causes pain, swelling, stiffness and loss of function in the joints, the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases says. It can affect any joint, but is most common in the wrist and fingers. Cimzia can have side effects including headache, upper respiratory infection, abdominal pain, nausea and injection site reactions. More information The FDA has more about this drug's approval history. Read more

Related support groups: Rheumatoid Arthritis, Cimzia

FDA Demands Tougher Warnings on Immunosuppressive Drugs

Posted 4 Sep 2008 by Drugs.com

THURSDAY, Sept. 4 – Federal health authorities have asked the manufacturers of four widely used immunosuppressive drugs to bolster safety warnings on the risk of developing opportunistic fungal infections. The drugs, Humira, Cimzia, Enbrel and Remicade, belong to a class of medications known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system and are approved to treat several conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn's disease. All four drugs already carry black-box warnings related to different safety issues, including fungal infections. "FDA has asked the manufacturers of these four drug products to highlight existing warnings of fungal infections," Dr. Jeffrey Siegel, clinical team leader in the division of anesthesia, analgesia and ... Read more

Related support groups: Enbrel, Humira, Remicade, Cimzia

FDA Medwatch Alert: Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)

Posted 4 Sep 2008 by Drugs.com

[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses.  For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the ... Read more

Related support groups: Enbrel, Humira, Remicade, Cimzia

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)

Posted 4 Jun 2008 by Drugs.com

[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, ... Read more

Related support groups: Enbrel, Humira, Remicade, Cimzia

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Crohn's Disease -- Maintenance, Crohn's Disease, Rheumatoid Arthritis, Crohn's Disease -- Acute