The change is being made to Amgen’s Aranesp and Johnson & Johnson’s Procrit to address concerns about the risks to cancer patients. The labels for the drugs now must say they are not indicated for patients undergoing chemotherapy with the intention to cure the patient, Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs.

The move follows a recommendation made last March by an FDA advisory committee that called for new limits on use for cancer patients over worries the drugs can increase the risk of tumor growth and death (back story).

This marks the first time the FDA is using authority granted last year to force a drugmaker to change labeling. Why? The agency and Amgen butted heads over two changes - Amgen wanted to include statements that weren’t supported by current data, while the FDA wanted the label to say the drugs aren’t to be administered when hemoglobin levels are greater to or equal to 10 grams per deciliter and that usage should stop if the hemoglobin exceeds a level needed to avoid transfusion.

And so the agency ordered Amgen to make all of the revisions. In a statement, Amgen pooh-poohed the disagreement and maintained the changes were “consistent with our expectations.”

Sources: Here and here