FDA is tacking new, stronger warnings on TNF-alpha blockers. The new label language highlights an increased risk of cancer in children and adolescents who take the blockbuster meds. These drugs include the Johnson & Johnson/Schering-Plough treatment Remicade, Amgen's Enbrel, Abbott Laboratories' Humira, UCB's Cimzia, and J&J/Schering's newly approved Simponi. These are billion-dollar meds, with Remicade alone generating almost $5.9 billion in global sales last year.
Used to treat rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriasis, and other inflammatory disorders, the meds already carry warnings of potential infection, because they work by suppressing the immune system. The new cancer warning is based on an FDA safety review begun over a year ago; the agency concluded that the drugs carry an increased cancer risk after 30 months of treatment on average. About half those cancers were lymphoma--which makes sense, because it involves immune-system cells--and some of the cancers were fatal.
Just how much might these warnings affect sales of the drugs? The conditions they treat are serious, even disabling. An Arthritis Foundation spokeswoman told HealthDay that patients should weigh the risks and benefits with their doctors. "The risks of the side effects are often very small, but the chance that a person with juvenile arthritis will be disabled and deformed is very high if they don't take therapy," Dr Patience White said. "People often focus on risks and forget the benefits."
- see the FDA release
- check out the story from HealthDay
- see the Wall Street Journal coverage