FDA Eyes Anemia Drugs‘ Cancer Risk Again

Jan. 3, 2008 -- The FDA today announced that it's reviewing more data on cancer risks tied to the anemia drugs Aranesp, Epogen, and Procrit.

Those drugs are erythropoiesis-stimulating agents (ESAs). They boost production of red blood cells and already bear?a "black box warning" (the FDA's toughest warning) about cancer risk.

That warning, launched in March 2007 and revised in November 2007, is based on six studies. Now, the FDA is reviewing two more studies from Amgen, the company that makes all three ESAs.

An FDA advisory committee will discuss the data and revisit the drugs' risks and benefits in the next few months.

Meanwhile, the FDA advises doctors and patients to review and discuss the risks and benefits of ESAs outlined in the product label.

The new studies provide "further evidence" of the drugs' risks, states an FDA news release.

The FDA notes that together, all eight studies (including the two new studies) show that tumors grew faster and survival rates were worse among patients with breast, non-small-cell lung, head and neck, lymphoid, or cervical cancers who took ESAs compared with those who weren't taking those drugs.

An FDA advisory committee will discuss the data and revisit the drugs' risks and benefits in the next few months.

Amgen provided the two new studies to the FDA in late November and early December 2007, according to the FDA. While Amgen makes all three ESAs, Procrit is marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson & Johnson.