In a development sure to spawn headlines across the country, the FDA is looking into a possible link between autoimmune drugs such as Remicade and Humira--known as TNF blockers for their action against tumor necrosis factor--and childhood cancers. The meds are already labeled with potential cancer risks for adults, but this is the first time the FDA has analyzed the risk in patients up to 18 years old. Why now? We're not sure, given that 30 reports of cancer in children and adolescents trickled into the FDA over the 10 years since the first TNF blocker was approved.
It's not a huge cognitive leap: TNF blockers do their job by suppressing the TNF protein, an immune-system component that causes inflammation. It also is potentially helpful against tumor cells. But these meds aren't for lightweight diseases, either. Thousands of kids take Amgen and Wyeth's Enbrel and Abbott Laboratories' Humira for rheumatoid arthritis, a serious and painful disorder that erodes joints. Johnson & Johnson and Schering-Plough's Remicade is approved for kids with Crohn's disease, which, left untreated, can destroy the intestines' ability to absorb nutrients. The FDA said in a statement that it believes the benefits of the drugs outweigh the risks--but also recommended that doctors consider the potential cancer link when prescribing.
FDA says the review will take about six months. Analysts are already hand-wringing over a possible black-box warning; Humira was Abbott's best-seller last year, with $3 billion in sales, and Remicade delivered $1.65 million to Schering-Plough. (The number of adults using these meds far outweighs the juvenile use, though.) Expect to hear more discussion of the possible cancer link June 18, when an agency advisory panel hashes over Amgen's application to market Enbrel for kids with psoriasis.