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(NaturalNews) Two drugs widely used to treat the anemia caused by chemotherapy can increase cancer patients' risk of dying by 10 percent, according to a study conducted by researchers from Northwestern University and published in The Journal of the American Medical Association. In response to the study, the FDA has convened an advisory committee to consider placing new restrictions on the drugs.
Researchers conducted a meta-analysis on 51 different clinical trials of two anemia drugs, involving a total of 13,611 patients. They found that cancer patients taking the drugs had 10 percent higher chance of dying and a 57 percent higher risk of blood clots than patients not taking the drugs.
The increased risk of death did not appear to come to the blood clots, but rather from a direct stimulation of tumor growth.
The FDA already strengthened warning labels on the drugs in 2007 when evidence of their risks first emerged, and Medicare revised its guidelines to only reimburse for certain uses in cancer patients.
After meeting March 13, the advisory committee is expected to recommend one of three courses of action. It could recommend that the agency place an outright ban on using the drugs in patients with certain varieties of cancer, such as of the breast or head and neck. It could recommend that the drugs only be used in more severe cases of anemia, or it could recommend that the FDA bring its guidelines into line with the new Medicare rules.
A complete ban on the drugs for chemotherapy patients would cost Amgen $1 billion per year in sales of the drug Aransep; synchronizing the FDA and Medicare rules would cost the company $300 million.
The other drug that would be affected by new FDA rules is Johnson & Johnson's Procrit. The Amgen drug Epogen, which is chemically identical to Procrit, would not be affected, because that drug is used for kidney dialysis patients and not for cancer patients.
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