FDA: More Label Warnings for Anemia Drugs

The Food and Drug Administration on Wednesday issued anticipated label revisions for anemia drugs such as Amgen's (AMGN Quote) Aranesp and Johnson & Johnson's (JNJ Quote) Procrit.

Revisions have been expected since a March advisory panel recommended to limit the drugs' use. The drugs, formally known as erythropoiesis stimulating agents, or ESAs, prompt the production of hemoglobin in patients undergoing cancer treatments, which can often cause severe anemia.

But data from clinical trials have shown that higher doses of the drugs may result in worse outcomes, such as higher risk of death and possibly tumor growth, for cancer patients.

Following a previous FDA advisory panel, in May of 2007, labels were changed to recommend the lowest dose of the drug also that patients hemoglobin levels not rise above 12 grams per deciliter.

The new revisions -- subsequent to the March 2008 advisory panel -- go a bit further. The new label mandate that patients with hemoglobin levels greater than or equal to 10 grams per deciliter not be started on the anemia drugs. Recall that Amgen had previously argued against Medicare's decision to not reimburse for use in patients with hemoglobin levels above 10.

Following the recommendation of the advisory committee, the new labels will also say the ESAs should not be used when chemotherapy is being used with the "intent to cure" the patient of cancer. Exactly how this will be interpreted is yet unknown, although it may refer to early-stage cancer patients who are being treated with adjuvant chemotherapy with the goal of complete elimination of the cancer.