Today an article published in the Journal of the American Medical Association claims that commonly used anemia drugs sold by Amgen and Johnson & Johnson raise the risk of death in cancer patients by about 10 percent. The publication, based on new analysis of existing clinical trial data, comes just as the FDA is planning to convene an advisory panel to address concerns associated with the medications. Amgen’s Aranesp and J & J’s Procrit will be evaluated by the panel to see if further restrictions should be placed on the drugs’ labels. The new analysis may play heavily on the advice of the panel.
One option that analysts expect to be discussed at the meeting in March would be to bar use of the drugs for specific types of cancer, such as breast cancer and head and neck cancer. Another option would be to delay treatment with the drugs until patients became more anemic than the current threshhold, a change that would more closely match the Medicare reimbursement policy.
The study also found a 57 percent increased risk of blood clots associated with the medications, reaffirming earlier concerns. A meta-analysis published in 2006 showed an 8 percent increased risk of death but this was just under the threshold of being considered statistically significant. The new study looked at 51 clinical trials of over 13,600 patients. This time the 10 percent increased risk was established to be statistically significant prompting publication and heightened concern about the future of these medications. The FDA advisory panel will convene on March 13th.