Health Boards
The U.S. health regulator has asked manufacturers of certain class of drugs, known as tumor necrosis factor (TNF) blockers, to submit reports of cancers in children and adolescents within 15 days of hearing of such cases.
In 2008, the Food and Drug Administration had said it was investigating the possible association between the use of TNF blockers in children and adolescents and increased risk of lymphoma and other cancers.
TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases.
TNF blockers are used to treat a wide variety of conditions including rheumatoid arthritis, psoriasis, Crohn's disease and ulcerative colitis.
They are widely used in products such as Johnson & Johnson's Remicade and Simponi, Pfizer Inc's Enbrel, Abbott Laboratories Inc's Humira and UCB SA's Cimzia.
The FDA said the new move will allow it to analyze all reported malignancies based on more complete and consistent reports.
The FDA also asked healthcare professionals to report malignancy in patients treated with TNF blockers to the agency or to the manufacturer.
In 2008, the Food and Drug Administration had said it was investigating the possible association between the use of TNF blockers in children and adolescents and increased risk of lymphoma and other cancers.
TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases.
TNF blockers are used to treat a wide variety of conditions including rheumatoid arthritis, psoriasis, Crohn's disease and ulcerative colitis.
They are widely used in products such as Johnson & Johnson's Remicade and Simponi, Pfizer Inc's Enbrel, Abbott Laboratories Inc's Humira and UCB SA's Cimzia.
The FDA said the new move will allow it to analyze all reported malignancies based on more complete and consistent reports.
The FDA also asked healthcare professionals to report malignancy in patients treated with TNF blockers to the agency or to the manufacturer.