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.