FDA orders Amgen to revise labels on growth factors

The Food and Drug Administration has ordered pharmaceutical giant Amgen to revise labels on its growth factor products, which stimulate the production of blood cells and are used in patients with low blood counts undergoing treatment for diseases such as kidney disease and cancer. Some data released in the past year has shown that these drugs may actually be dangerous for cancer patients if used too prolifically. Sales of Amgen’s products have been falling since this data was released; moreover, Medicare has cut back coverage/reimbursement for some uses of the drugs and narrowly restricted their use — these drugs are expensive.

 The new labels will restrict starting therapy until a patient’s hemoglobin drops to 10. The label will no longer suggest that it is safe to treat until the hemoglobin rises to 12. Normal hemoglobin range is about 13 – 18 for men (grams per deciliter) and 12 – 16 for women (grams per deciliter).

 A change in labeling might continue to negatively impact Amgen’s sales in this area, but many hospitals and physicians have been trimming the drug’s use with cancer patients already, so the fall might not be as big as some analysts are predicting. Overall, Amgen is still strong. They have seen good results in a clinical trial of a new bone drug, and their shares are on the rise.