The FDA seems to be getting more comfortable with issuing black box warnings. The latest group of drugs on the watch list -- tumor necrosis factor (TNF) blockers -- are linked to rising cancer risks among children and adolescents.
The agency began investigating TNF blockers after reports of several dozen children developing cancer surfaced more than a year ago. Malignancies were diagnosed some 21/2 years after kids started taking these drugs and roughly half led to lymphomas.
What really grabbed the attention of the FDA: A New England Journal of Medicine report about a Chron's disease sufferer and lung cancer patient whose cancer went into remission after she stopped using a TNF blocker.
TNF blockers receiving black box warnings from the FDA:
Cimzia
Enbrel
Remicade
Humira
Simponi
HealthScout August 4, 2009
Wall Street Journal August 4, 2009
Remicade and Simponi are trademarks of Centocor Ortho Biotech.
Enbrel is a trademark of Amgen and Wyeth Pharmaceuticals.
Humira is a trademark of Abbott Laboratories.
Cimzia is a trademark of UCB.