Amgen Told to Reword Drug Label

The FDA required Amgen to revise the label for Procrit and Aranesp so that these agents are not used until a patient's hemoglobin drops below 10 or in the setting of potentially curative therapy.

While the debate arisen in the last years about the optimal target of haemoglobin in uremic patients finished when Choir and Create’s studies were published, in cancer patients’ field the discussion is still open. Nowadays there is not yet evidence that the normalization of haemoglobin’s level in cancer patients is safe and useful, but, rather, high levels can worsen thrombosis process and the evolution...

It is important to remember that there are many more "treatable" cancers diagnosed than curable cancers. The initiation of chemotherapy after surgical removal of a neoplasm is a signal that there may be undetectable metastatic disease.  You are therefore hoping for a cure but accepting the reality. When there is a need to increase the blood volume a product such as those in this article do not...

1)  Concerns over the new FDA restrictions on ESA's is being overstated. 2)  Amgen will continue to do well in the ESA market place, in spite of these changes. 3)  J&J will receive the brunt of these changes, strictly because of their market concentration in the oncology market. 4)  Amgen will continue on as the "King of US ESA's".

The FDA used new power to order Amgen to change its product label for its Epo Stimulating Agents (ESAs).  The new label will reflect what Medicare reimbursement guidelines have recently oulined.