Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
REMICADE®/ENBREL®/HUMIRA®
August 4, 2009. The Food and Drug Administration (FDA) has ordered a stronger boxed warning on Enbrel®, Humira®, Remicade®, and other drugs known as tumor necrosis factor, or TNF, about the risks of cancer in children who take the drugs for treating juvenile rheumatoid arthritis, Crohn's disease, and other inflammatory diseases. The agency said a new cancer-related warning will be added to the boxed-warning that is already on the drugs. The drug labels previously discussed a possible risk of cancer but do not mention leukemia. The boxed warning, which is the FDA's strongest drug warning, currently warns of the risk of developing serious infections that can be fatal.
The TNF class of drugs is approved to treat various immune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease and ankylosing spondylitis. The drugs suppress the immune system by blocking TNF, a substance in the body that causes inflammation and can lead to various immune-system related diseases.
The popular brand name drugs covered by the FDA warning and their generic equivalents are:
- Remicade® (infliximab)
- Enbrel® (etancercept)
- Humira® (adalimumab)
- Cimzia® (certolizumab pegol)
- Simponi® (golimumab)
The cancers appeared, on average, 30 months after treatment with the drugs and about half of the cancers were lymphomas of cells in the immune system. In some cases, the cancers caused by taking TNF blockers were fatal, the FDA cautioned.
The FDA said it was working with manufacturers - including a unit of Johnson & Johnson, which makes Remicade® and Simponi®, Abbott, the maker of Humira®, as well as Amgen and Wyeth, which co-market Enbrel® - to define the risk of cancer in children and adolescents.
If you or someone you love developed cancer or suffered other adverse effects after using Humira®, Remicade® or Enbrel®, you may be entitled to financial compensation. Please fill out our online form, or call 1-850-444-9500 or toll free at 1-888-839-3775 to discuss your valuable legal rights with one of the experienced defective drug attorneys at our firm.
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