The drumbeat of data is getting louder. A new analysis of the blockbuster anemia drugs sold by Amgen and Johnson & Johnson concludes they raise the risk of death among cancer patients by about 10 percent. It's the first meta-analysis to show a statistically significant increase in the risk of death from these drugs, said the lead author of the study, to be published in the Journal of the American Medical Association today.
The FDA is convening an advisory panel March 13 to discuss whether to further restrict the drugs, which already have seen their usage limited by Medicare, the U.S. Department of Veterans Affairs and Canadian regulators. The FDA ordered stronger warnings on the drugs--Amgen's Epogen and Aranesp and J&J's Procrit--last year. Since then, sales have declined by hundreds of millions of dollars.
Monday, the U.K.'s National Institute for Clinical Excellence posted proposed guidelines that advocate their use only in patients with ovarian cancer or in cancer patients whose anemia became life-threatening. The guidance didn't offer changes to the meds' use in kidney patients. NICE is accepting comment on the proposal through March 7.
- see the article in the New York Times
- check out the FDA's advisory meeting announcement
- read the proposed NICE guidelines (.pdf)
- find links to related NICE documents (.pdf)