TNF Blocker Cancer Lawyers. If your child is being treated with a TNF blocker – a class of drugs that includes Remicade, Remicade, Humira, Cimzia and Simponi – you should know that they may face a higher risk of cancer. It is known that at least 48 children and teens have developed cancer, including a life threatening type of lymphoma, while taking these drugs. Eleven of these young cancer victims died.
TNF blockers have become blockbusters for their manufacturers. Last year alone, these drugs generated about $15 billion in sales. Unfortunately, this blockbuster status has come at a high cost. The manufacturers of TNF blockers need to be held accountable for the misery these drugs have caused.
If a child you love was treated with a TNF blocker and developed cancer, your family may be eligible for compensation. Our TNF blocker cancer lawyers are offering free case evaluations to families of children stricken with lymphoma and other cancers that may be associated with Enbrel, Remicade, Humira, Cimzia and Simponi. We urge you to contact one of our TNF blocker cancer lawyers right away to protect your legal rights.
In children, TNF (tumor necrosis factor) blockers are used to treat rheumatoid arthritis, inflammatory bowel disorder and Crohn’s disease. They are also approved to treat a variety of chronic, inflammatory and autoimmune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF blockers work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.
Cancer Risk to Children
In August 2009, the cancer risk to children posed by TNF blockers prompted the Food & Drug Administration (FDA) to order additional information about this danger be added to the Boxed Warnings of Remicade, Enbrel, Humira, Cimzia and Simponi. The drugs already carry a black-box warning that they may cause cancer. But the FDA said the warning labels must highlight the drugs’ possible risk of lymphoma and other cancers in children and teens.
The FDA had been studying the link between the pediatric uses of TNF blockers and cancer since 2008. The safety review was prompted by approximately 30 reports of cancer in children and adolescents treated with TNF blockers. Cimzia, approved in April 2008, and Simponi, approved in April 2009, were not included in the FDA’s review because they are not approved for use in children and were minimally used during the review period.
According to a notice posted on the FDA’s Website on August 4, 2009, the agency had identified 48 cases of malignancies in children and adolescents treated with TNF blockers. Of the 48 cases reviewed by the FDA, approximately half were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. Other malignancies reported include leukemia, melanoma, and solid organ cancers. Malignancies such as leiomyosarcoma, hepatic malignancies, and renal cell carcinoma, which are rare in children, were also reported.
Of the 48 cases of cancer, there were 11 deaths, the FDA said. The causes of death included hepatosplenic T-cell lymphoma (9 cases) and T-cell lymphoma (1 case). In the remaining case, the patient died from sepsis after achieving remission of the lymphoma.
The FDA analysis showed that U.S. reporting rates for cases of malignancy with Remicade were consistently higher compared to expected background rates for lymphomas and all malignancies. The malignancy reporting rates for Enbrel were also higher than background rates for lymphomas, but were similar to background rates for all malignancies. The malignancy reporting rates for Humira and Cimzia were not calculated during the analysis because of minimal use in pediatric patients. Simponi was not approved at the time of the analysis and therefore was not included.
The majority of the 48 patients (88%) were also using other immunosuppressive medications such as azathioprine and methotrexate, which according to the FDA, currently have warnings of increased risk of lymphoma in their prescribing information. Although there were other contributory factors, the role of TNF blockers in the development of malignancies in children and adolescents could not be excluded.
Stronger Cancer Warnings for TNF Blockers
Based on its safety review, the FDA concluded there is an increased risk of malignancy with TNF blockers. The agency required the manufacturers of TNF blockers to update the Boxed Warning in the prescribing information to alert healthcare professionals of an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers. Along with updating the drugs’ labels, the FDA is requiring companies to add information about cancer risks to patient medication guides. The FDA said it is also working with the manufacturers to further define the scope of the cancer risk.
In addition to the updated Boxed Warning, the FDA also required several other changes to the prescribing information for TNF blockers to warn of and mitigate the risks associated with these drugs. These changes are based on additional safety reviews and include:
- Update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children. Changes to the Warnings section of the labeling will also include additional information on malignancies in children and adolescents (see also Boxed Warning information above).
- Updateto the Adverse Events section to include information on reported cases of new-onset psoriasis.
- Revised Medication Guide to reflect this new safety information.