FDA Mandates Stronger Warnings on Amgen’s Epogen and Aranesp, and Johnson & Johnson’s Procrit Which are all Prescribed to Treat Anemia

By November 9, 2007 Drug Safety

The manufacturers of Epogen, Aranesp, and Procrit used to treat anemia, strengthened the warnings to drugs yesterday, to warn that the drugs could cause heart attacks, worsen cancer and even cause death.
The changes, were made after they submitted data to the Food and Drug Administration which evidenced that the drugs can be dangerous if overused. The new warnings also state for the first time that the drugs’ risks for cancer patients cannot be excluded even at doses previously considered safe and routinely used.
The drugs are used by about one million Americans a year, mostly people with anemia caused by cancer chemotherapy or kidney failure. Combined sales worldwide were nearly $10 billion last year.
For cancer patients, the new label calls for using the lowest possible dose that allows a patient to avoid blood transfusions, with hemoglobin levels not to exceed 12 grams for each deciliter. “The label gives physicians discretion between 10 and 12,” Kevin W. Sharer, Amgen’s chief executive, said yesterday. “ “This is not a target,” Dr. Richard Pazdur, the director of the agency’s cancer drug office, said about the hemoglobin level of 12. “This is an upper boundary for safety concerns.”
The new labels came after the F.D.A. held two advisory committee meetings to consider the safety of the drugs. The agency had first slapped a so-called black box warning, the toughest kind, on the drugs in March as an interim measure.
For patients with kidney failure, the label calls for hemoglobin levels to be maintained at between 10 and 12. That is perhaps a bit less restrictive than the label in March. But new wording in the label calls for doctors to exercise restraint or possibly discontinue use for patients who do not reach the desired hemoglobin levels after 12 weeks of treatment. Until now, dialysis centers have tended to give such patients very large doses in an effort to raise their hemoglobin levels.
This along with all of the other new warnings and limitations on drugs after they have been on the market demonstrate the weakness in drug safety in the United States. To get a drug approved the FDA does not require studies of a sufficient number of patients to demonstrate safety risk that occurs infrequently. This gap in our drug safety system is part of the cause of all of recent drug debacles such as Vioxx, Bextra, Avandia, Fen Phen, Baycol, etc…. This problem keep on occurring until the system is fixed.