TNF Blockers Required to Update Labels to Include Cancer Warnings
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After its initial Early Communication in June of 2008, the Food and Drug Administration (FDA) is requiring the manufacturers of tumor necrosis factor or TNF blockers update their labels to warn users of the potential for an increased risk of cancer in children and adolescents.
TNF blockers are used to treat children and young adults who suffer from Crohn’s disease, and juvenile rheumatoid arthritis, as well as other inflammatory diseases. Crohn’s disease is an inflammatory bowel disease (IBD) that begins in the intestines. The TNF blockers neutralize and actually target necrosis factor-alpha (TNF-a) which is a protein that can cause damage to bones, cartilage and tissues in the body if it is overproduced because of the above listed inflammatory disease.
The TNF blockers that are on the market today and must include the new boxed warnings on their labels are: Humira (adalimumab), Remicade (infliximab), Cimzia (certolizumab pegol), Enbrel (etancercept) and Simponi (golimumab).
The FDA first became aware of the increased cancer risk in 2008 when it was reported that children and adolescents who used the TNF blockers had an increase in cancer after using the treatment for at least 30 months. Most of the cancers that resulted were lymphomas which affect the immune system and some of the cancers were fatal. Lymphomas are not recognized as a complication of any of the inflammatory diseases that require the use of TNF blockers.
In addition, the FDA is also asking the manufacturers to update the safety information to include the risk of new-onset psoriasis and leukemia in children and adolescents who use the TNF blockers to treat their inflammatory illnesses. The medications do carry a warning at this time but do not identify leukemia specifically.
The FDA has urged medical professionals to report any side effects that they see as a result of their patient’s use of TNF blockers. Since the drug was approved by the FDA in 1998 there have been about 30 reported cases of cancer in children and young adults who use them.
The company who manufactures Cimzia is conducting a 10-year test to determine the long term risks of developing any type of cancer, especially lymphoma, after using the TNF blockers for a longer period of time. The FDA sends information directly to medical professionals warning them of possible side effects when medications begin to show serious side effects. In this case, they have not suggested an alternative form of treatment and actually believe that the benefits of using the medication outweigh the potential risks.
If you have a child or an adolescent who suffers from Chron’s disease, juvenile rheumatoid arthritis or any other type of inflammatory bowel disorder and has used or still does use TNF blockers and has exhibited signs of cancer, you may want to contact a legal professional to determine your rights.
At Napoli Bern Ripka LLP we have been dealing with the aftermath of FDA recalled drugs and medications that have been shown to have serious side effects for years. Our legal team brings their experience to the table and is familiar with this case as well as many others just like it. Give us a call at 1-888-LAW-IN-NY.