FDA reviewing Humira, Remicade and Enbrel for cancer risk
According to a notice published today on the Food and Drug Administration website, FDA is investigating the possible association between the use of tumor necrosis factor (TNF) inhibitors and the development of lymphoma and other cancers in children and young adults. These individuals were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn's disease or other diseases.
If you, your child or a patient of yours has developed cancer or another serious side effect while using Remicade, Enbrel, Humira, or Cimzia, the FDA asks that you report side effects from the use of these drugs to the FDA's MedWatch Adverse Event Reporting program in one of the following ways:
- online at www.fda.gov/medwatch/report.htm;
- mailing the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787;
- faxing the form to 1-800-FDA-0178; or
- calling at 1-800-332-1088.
The FDA has asked the manufacturers of Remicade, Enbrel, and Humira (including Abbot Labs, Schering Polugh, Amgen and Wyeth) to provide FDA with information about all cases of cancer reported in children taking TNF blockers. FDA is requiring UBC, the maker of Cimzia, to conduct a study to assess long-term risks of the product, including lymphoma and other cancers. The study will begin in 2009 and take about 10 years to complete. FDA is also looking to other medical experts to study whether there are children and young adults with JIA and Crohn's disease who may be at particular risk for developing cancer as a result of taking these drugs.
The FDA was careful to note that it would communicate its conclusions of its studies to the public. It also points out that it believes that the benefits of taking these drugs outweigh the potential risks for children and young adults.
So far, the FDA has only received approximately 30 reports of cancer in children and young adults over the past ten years. These reports were submitted to FDA's Adverse Event Reporting System beginning in 1998 through April 29, 2008. These reports described cancer occurring in children and young adults under 18, who took TNF blockers (along with other drugs such as methotrexate). Approximately half the cancers were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. Other cancers reported included leukemia, melanoma, and solid organ cancers.
The FDA stated that it is conducting the additional investigation because "the reports of these events in children and young adults receiving TNF blockers are of concern and deserve further investigation." The FDA also called for further long-term studies to determine whether TNF blockers increase the occurrence of cancers; research that short-term studies cannot provide.
The four TNF blockers currently available in the United States are Remicade, Enbrel, Humira, and Cimzia. Each are approved to treat one or more of a number of immune system diseases including RA, JIA, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis. Remicade is approved for use in children to treat Crohn's disease. Enbrel and Humira are approved for use in children to treat JIA. Humira was just approved by the FDA for use in children in February 2008.
The association between the use of TNF blockers and the development of serious infections and several types of cancer in adults has been well documents over the past several years. Patient information for all four TNF blockers warns about the possible risk of cancer. There is also a documented risk for children and young adults with Crohn's disease treated with Remicade and immunosuppressive drugs such as azathioprine or 6-mercaptopurine of developing hepatosplenic T cell lymphoma.
For more information and the report, see http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm