Personal Injury Law

FDA Probes Arthritis Drug and Cancer Reports in Kids

By Jane Akre

The FDA will investigate the link between drugs, given to treat rheumatoid arthritis and Chrohn's disease over a decade, and the development of lymphoma and other cancers in children and young adults.

The medications, called TNF blockers include, Johnson & Johnson's Remicade, Abbott Laboratories Humira, and Amgen and Wyeth's Enbrel.

Children and young adults under the age of 18, were treated with the drugs between 1998 and 2008.  About 30 have developed cancer.

Half of the cancers reported were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Other cancers include leukemia, melanoma and solid organ cancers.

Another drug in the same class, Cimzia, was approved in April of this year. It will be required to conduct a study on long-term risks, including cancer.

The FDA says long-term studies are needed to answer the questions. The agency is asking manufacturers of the TNF blockers to provide information about cases of cancers among children treated.  Studies will begin next year and will take 10 years to complete.

TNF blockers suppress the immune system by blocking the activity of TNF, a substance that causes inflammation and can lead to immune system-related diseases such as JIA, and Crohn's disease, according to the FDA.

Amgen and Wyeth tell Reuters they support the FDA review and will provide requested information. The other manufacturers could not be reached.

"At the current time, the FDA believes that the potential benefits of the use of TNF blockers outweigh the potential risks in certain children and young adults," the FDA said in a document on its Web site.

Consumers are being asked to report adverse events related to the drugs by calling 1-800-332-1088 or go to the FDA's Medwatch Web site to make a report.

Patients discuss the pros and cons of TNF blockers online on the Daily Strength web site. 

The Daily Mail newspaper in Britain, carried a story last April of a teenager who beat rheumatoid arthritis with that class of drugs.  # 

Full post as published by InjuryBoard on June 04, 2008 (boomark / email).