FDA Investigates Possible Association of Enbrel, Humira and Remicade with Lymphoma Cancer in Children
Published: June 5th, 2008 • Comments: 6
The FDA is conducting a safety review of several medications used to treat arthritis, Crohn’s disease and other conditions among children. The agency is investigating reports of children and young adults using Remicade, Enbrel and Humira who developed lymphoma and other cancers.
The arthritis drugs, known as Tumor Necrosis Factor (TNF) Blockers, are commonly used along with other immunosuppressive drugs, such as methotrexate, azathioprine or 6-mercaptopurine, to treat Juvenile Idiopathic Arthritis (previously known as Juvenile Rheumatoid Arthritis), Crohn’s disease and other immune system diseases.
According to the FDA’s Adverse Event Reporting System, between 1998 and 2008, approximately 30 children using Remicade, Enbrel and Humira reportedly developed cancer. About half of the cancers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma. The other cancers included leukemia, melanoma and solid organ cancers.
The “early communication” issued by the FDA does not mean that there is a definitive causal connection between the drugs and the emerging safety issue, but the agency is investigating a possible association. All of the drugs currently carry information about a possible cancer risk, but experts have been looking for clarification about the risks among children.
“While cancers are known to occur in children and young adults, the reports of these events in children and young adults receiving TNF blockers are of concerns and deserve further investigation,” said the FDA in a statement released Wednesday. “Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies.”
The auto-immune disorder drugs are huge sellers nationwide, and the revenue generated account for a large portion of the total revenue for the pharmaceutical companies who sell the drugs. Remicade, which is manufactured by pharmaceutical giant Johnson & Johnson, reported revenue of nearly $1 billion in the first quarter of 2008, which is about 6% of the Johnson & Johnson’s total revenue for the quarter. Abbott Laboratories, Inc.’s Humira generated $878 million in first quarter sales, compared to total quarter revenue of $6.76 billion for the company. Enbrel, which is marketed jointly by Amgen, Inc. and Wyeth, generated $951 million for the quarter, compared to combined revenue of $9.3 billion for both companies’ first quarters.
A fourth TMF blocker, known as Cimzia, is manufactured by UCB and was just recently approved by the FDA on April 22, 2008. The manufacturer is beginning a ten year study next year to access the long-term risks of Cimzia, including lymphoma and other cancers.
Despite the risk of childhood cancer possibly associated with Remicade, Enbrel, Humira and Cimzia, the FDA does not indicate that recalls or a change in approval for use in children is being considered. The statement suggests that the potential benefits still appear to outweigh the potential risks for children and young adults. The regulatory agency has requested that the drug makers provide information about any reports of cancer in children taking their drugs. It is estimated that the FDA safety review will take about six months to complete and determine what conclusions or recommendations will be made.
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Comment by Eric on 27 December 2009:
I have been using Enbrel for about four years and have just been diognosed with Lymphoma.
Comment by sarena on 26 January 2010:
Eric, pls tell me that you’re not serious. i have just read this and your post. i’ve been on enbrel for 4.5 yrs for PsA and am now panicked, don’t know whether to come off enbrel, quit my job that i’ve spent years working on to adopt a strict lifestyle that hopefully won’t require the use of TNF drugs. i’m so panicked. oh and i’m pregnant as well with my first…
Comment by Nancy on 9 March 2010:
I felt my husband’s story fits this article.
From 2001 until December 2005, my husband, Lewis, took Remicade, Enbrel, and Humira for RA. In February 2005 he was first diagnosed with monoclonal protein in his blood. Then, on March 8, 2007, he was diagnosed with Non Hodgkin’s Mantle Cell Lymphoma. He began taking the drugs before Johnson and Johnson, i.e. Centocor, Abbott, and Amgen/Wyeth announced that TNF Inhibitors could cause Lymphoma. Upon diagnosis, my husband was given six months to live; however, he had a Stem Cell Transplant on August 27, 2007, at Wake Forest Medical Center, Winston-Salem, NC. His last CT Scan still shows tumors in his abdominal area. Our family and especially Lewis, have been and are still going through a nightmare over these drugs. All RA victims need to be aware of what these TNF Inhibitors can do to them. This should not be happening to Lewis.
Through our experience with these drugs, we have learned that if someone is a victim of deadly Lymphoma from taking these drugs, there is no recourse. Doctors won’t help because the drug companies treat them to luxurious trips and vacations so the doctors will prescribe the drugs to patients. Furthermore, hospitals won’t help because these drug companies are benefactors on building and equipment projects for the hospitals. Therefore, families just continue to suffer over the results of these drugs. We hired an attorney who found these facts for us.
We know these drugs caused this deadly Lymphoma in my husband. He and his sister are within one year in age, they both have the same genes and the same degree of RA. Lewis was treated with these three drugs and his sister wasn’t treated with the drugs. Lewis has Non- Hodgkin’s Mantle Cell Lymphoma and his sister doesn’t have it. Unique case, proof that the drugs caused the Lymphoma in my husband. His doctor has written three letters stating that he believes that the TNF Inhibitors caused the Lymphoma because his sister did not take the drugs and she is fine. Also, the RA doctor found the Monoclonal protein in Lewis’s about six months before the found the Lymphoma. Please share this truth about TNF Inhibitors. Remicade, Enbrel, and Humira are KILLER drugs. This is not fiction; this is a man’s life. One life is One too many. These drugs are not just affecting children, they are killing middle aged people also.