FDA: More Label Warnings for Anemia Drugs

The March panel also recommended that anemia drugs should not be used in patients with metastatic breast cancer or cancer of the head and neck. This is one place that the FDA apparently overruled, as that recommendation will not be in the label revisions.

The aforementioned safety concerns and reimbursement issues have depleted sales of these drugs -- which make up Amgen's most profitable franchise -- over the past year. In the recent quarter, Aranesp sales were down 13% year over year but surpassed expectations, contributing $835 million to Amgen's quarterly revenue. CEO Kevin Sharer said sales will likely enter 2009 at a yet lower rate in light of label changes.

"This label is consistent with our expectations," said Amgen in a statement on Wednesday in response to receipt of the FDA's revisions. "We will soon be communicating the revised product labeling for ESAs to both physicians and patients."

The company also said that the potential impact of this revised label was factored into its updated guidance -- on Monday Amgen raised its revenue guidance to between $14.6 billion and $14.9 billion, from a prior range of $14.2 billion to $14.6 billion. On a per-share basis, the company anticipates adjusted profit of between $4.25 and $4.45, up from a prior range of between $4 and $4.30.

Amgen's shares closed Wednesday essentially flat. J&J closed down 0.6%.