Humira: Rheumatoid Arthritis and Inflammatory Bowel Disease Linked to Childhood Cancers

Humira, a member of a class of drugs called TNF blockers that is used to treat juvenile rheumatoid arthritis and Crohn’s disease, is associated with increased risks of life-threatening cancers in children and other serious health complications.

The drug, known chemically as adalimumab, also has been linked to cases of tuberculosis, fungal infections, and other opportunistic infections. Other brands of TNF blockers that also have been associated with increased cancer risks in children, along with their generic names and manufacturers, include:

• Remicade (infliximab) Johnson & Johnson/Schering-Plough

• Enbrel (etancercept) Amgen/Wyeth

• Cimzia (certolizumab pegol) UCB

• Simponi (golimumab) Centocor Ortho Biotech

FDA Orders Stronger Cancer Warnings

In August 2009, the Food and Drug Administration ordered the makers of Humira and other TNF blockers to include stronger warnings about the risk of cancer on the drugs’ packaging. The tougher warnings came after the FDA determined that children treated with the drugs were developing lymphomas of cells in the immune system and other cancers on average 30 months after treatment with the drugs.

In some cases, children died as a result of developing the cancers.

The FDA also required the makers of the drugs to update the prescribing information and include the risk of developing the chronic skin disease psoriasis, which also has been associated with the use of TNF blockers.

Dozens of Cancers Linked to TNF Blockers

Between 2001 and 2008, there were 48 reports of cancers in children and adolescents treated with TNF blockers, the FDA said. Of those reports, there were 10 cases of hepatosplenic T-cell lymphoma, seven cases of non-Hodgkin’s lymphoma, six cases of leukemia, and six cases of Hodgkin’s lymphoma.

There were 32 cancers reported in the United States and 16 cases reported from outside the United States, the FDA said.

Children treated with various doses of Humira and the other TNF blockers developed the cancers and there was no specific dose associated with the increased cancer rate, the FDA said.

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