New warnings on Amgen and Johnson & Johnson's anemia drugs don't just highlight the risk of heart attack, heart failure, stroke, and cardiac death. They also point out that the drugs sometimes cause tumors to grow faster and cut certain cancer patients' lives short. And though the warnings state that cancer-progression risks are greatest at higher doses, they also emphasize that there's no evidence that lower doses don't cause the same problems. Adding insult to injury, the new labeling also states that the drugs don't improve quality of life for patients.
Harsh language? Amgen isn't billing it that way. The companies called the new warnings a simple communication of information that doctors and patients can use to make decisions. And industry analysts said the labeling could have been worse. "Not bad," one told The New York Times.
One analyst suggested that the new label would cut sales because dialysis centers will no longer give patients huge doses to boost hemoglobin. Those enormous doses "have historically been a major source of revenue for Amgen," the analyst wrote in a note to clients. Meanwhile, Amgen is still fighting with Medicare about the programs' dosing limits--even using the new warnings' language as ammo. But the FDA says the Medicare limits are consistent with the new label.