An agency panel meets Thursday to review safety issues surrounding Amgen’s Aranesp and J&J’s Procrit, particulary in cancer patients. And documents released today on the FDA web site indicate FDA medical reviewers remain cautious.

More data is needed on risks, labeling changes may be necessary to restrict which patients should use them or further limit dosing may also be appropriate. The drugs “clearly demonstrated to be unacceptable” in high doses, an FDA analysis indicates.

The agency staff cited five studies showing patients died sooner on the drugs than those in a control group. A number of studies showed an increased risk of thrombovascular problems, which can include heart attacks and strokes, FDA staffers wrote.

“We need clear guidelines for the use of these products that say where to start using them and where to stop,” Peter Eisenberg, a cancer physician in Marin County, California, told Bloomberg News. “`We need them because there’s a risk we didn’t fully appreciate before.”

In March, FDA officials called for a Black Box warnings on the meds and urged docs to use the lowest dose to avoid blood transfusions. The drugs are approved to treat anemia in cancer patients receiving chemotherapy, and are also cleared for patients with chronic kidney failure.

Separately, Amgen and J&J conducted a review and analysis of available safety data, which they said supports use of anemia drugs as labeled. “Ongoing pharmacovigilance studies will further inform the risk/benefit assessment in the near future,” they wrote in another document.

Analysts have been mixed over what the FDA panel will do. In an investor note this morning, Mark Schoenebaum of Bear Stearns, who met with Amgen execs recently, wrote that the “meeting is unlikely lead to further restrictions on Aranesp use.” However, he added Amgen is “unlikely to convince the FDA to remove any of the new warnings from the Aranesp label.” The Amgen presentation will be led by Duke University’s Jeff Crawford.

Further reading…
Reuters;
Bloomberg News;
The Wall Street Journal (subscription required);
FDA and Amgen briefing info.
[tags]Amgen, Aranesp, Drug Safety, Johnson & Johnson, Procrit[/tags]