The FDA has received 30 reports of cancer in children under the age of 18 who had been treated for JIA with anti-TNF drugs along with other medications, such as methotrexate, or similar immunosuppressant drugs.

Nearly 50% of the reports state the patients developed Hodgkin’s and non-Hodgkin’s lymphoma. The other reports indicate development of melanoma, leukemia and solid organ cancers.

Besides rheumatoid arthritis, TNF blockers are used to treat psoriatic arthritis, Crohn’s disease, plaque psoriasis, ankylosing spondylitis, as well as other diseases. TNF blockers are know to result in inflammation and weakening of the immune system.

The manufacturers of these drugs have been directed by the FDA to provide information about all TNF blocker recipients who have developed cancer, and in some cases to track cancer reports for 10 years. The FDA has also requested the assistance of medical professionals and patients in reporting any side effects from TNF blockers through the MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

Originally posted 2008-06-06 22:25:05. Republished by Blog Post Promoter

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The packaging already is required to warn about fungal infections in general, but the new warnings will have to specifically call out histoplasmosis. This is a result of the FDA receiving reports of 240 patients who were taking TNF blockers that developed histoplasmosis. Of those 240, 45 patients died, including at least 12 who had not been immediately been diagnosed with histoplasmosis leading to a delay in treatment. The ages of these patients ranged from 8 to 86 years, however, none of the deaths involved children.

Histoplasmosis starts in the lungs and can spread to other organs in the body. If not treated in time, it can lead to death. In healthy people the body’s immune system is able to control the histoplasmosis infection. The risk is to people that have compromised immune systems, such as patients with AIDS or taking immune system suppressing drugs, such as alpha blockers.

The fungus that causes histoplasmosis, histoplasma capsulatum, is found throughout the world. It grows in the ground and in material that is contaminated with bat or bird droppings. Concentrations can be especially high in bird roosts, caves where bats roost and poultry house litter. Histoplasmosis is also more common in the Mississippi and Ohio River Valleys.

Symptoms of histoplasmosis include shortness of breath, fatigue, cough and fever.

Anti-TNF drugs are used to treat rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, ankylosing spondylitis and Crohn’s disease.

The FDA published their directive on September 4th. You can read the actual release here

Originally posted 2008-09-06 18:46:48. Republished by Blog Post Promoter

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On May 1st, the U.S. Food and Drug Administration (FDA) announced that it has required a warning label be added to Enbrel to increase the awareness of the risk of infections, particularly tuberculosis. The updated warning recommends screening for latent tuberculosis infection (LTBI) before beginning treatment with Enbrel.

It also warns that patients be monitored for possible antimicrobial treatment if the develop an infection and to stop taking Enbrel if a serious infection develops.

“Tuberculosis has been observed in patients receiving TNF-blocking agents, including Enbrel,” according to the warning. “Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbel.”

The warning’s section on adverse events now says, “In global clinical studies of 20,070 patients (28,308 patient-years of therapy), tuberculosis was observed in approximately 0.01% of patients. In 15,438 patients (23,524 patient-years of therapy) from clinical studies in the U.S. and Canada, tuberculosis was observed in approximately 0.007% of patients. These studies include reports of pulmonary and extra-pulmonary tuberculosis.”

The changes were distributed to clinicians in a letter from Amgen and Wyeth, which market the drug for the manufacturer, Immunex.

Originally posted 2008-05-03 21:47:03. Republished by Blog Post Promoter

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The study of adalimumab was led by Dr. Daniel J. Lovell, professor of pediatrics at Cincinnati Children’s Hospital Medical Center. Treatment with adalimumab was found to reduce disease flare-ups and resulted in improvements in patients with juvenile rheumatoid arthritis. Three quarters of the patients had at least a 50 percent decrease in disease symptoms after 16 weeks. In addition, 58 percent of the patients had at least a 70 percent decrease in American College of Rheumatology Pediatric response criteria (measurement criteria that assess disease activity in JRA patients).
After 32 weeks, patients who received adalimumab had significantly fewer disease flare-ups and better ACR Pedi Responses than those who took a placebo. Patients who continued taking the drug for two years showed substantial and sustained improvement, according to the researchers.
Another study led by Dr. Lovell investigated the tolerance of abatacept on children with severe polyarticular juvenile idiopathic arthritis. The researchers conducted a randomized double blind study of abatacept and reported that the results were encouraging for both safety and efficacy for these patients.

The third study was conducted on etanercept, in injectable drug which blocks TNF-alpha. TNF-alpha is a protein that causes the pain and tenderness associated with rheumatic disease.

This research was conducted on 42 JRA patients who took etanercept for 4 years of which 26 continued to take it for 8 years. Those that discontinued use cited parental desire to remove the patient from the study, poor treatment response, adverse effects or a doctor’s decision.

Results from this study found that etanercept is safe for long term treatment of patients with JRA. The rate of serious events didn’t increase with long term use and only one serious infection, a kidney infection, was observed in the last 4 years of the study.

Originally posted 2007-12-13 15:29:03. Republished by Blog Post Promoter

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