FDA Panel Wants Anemia Drug Warnings
Experts Concerned Drugs Are Overprescribed Despite Risks
May 10, 2007 -- An expert panel on Thursday urged the FDA to further rein in
doctors' use of drugs that stimulate red blood cells because of mounting
evidence that the medications cause some patients to die early.
The experts called for new warnings on anemia drugs used to boost production
of red blood cells. The move comes only weeks after the agency warned the
public that the drugs may speed cancer growth and spur heart attacks and other
The drugs were approved because of their ability to lower the need for blood
transfusions in cancer patients who have anemia (low red blood cell count) due
to chemotherapy. But clinics and hospitals have seen an explosion in use of
these drugs that FDA scientists and cancer experts say has gone beyond the
state of scientific knowledge.
Experts Thursday complained that aggressive industry marketing to doctors
and patients has prompted overuse of the drugs and may be contributing to
In March, the FDA placed "black box" warnings on the three drugs
available in the U.S.: Epogen, Procrit, and Aranesp. The warnings alert
patients and doctors to lessen the risk of blood clots by using the lowest dose
of medication needed to avoid the need for blood transfusion.
The boxed warning also includes information that the drugs can increase the
risk of death or serious medical complication such as heart attacks and strokes
if used too aggressively in some patients.
Most evidence suggests that the increased risks are the result not of
recommended use, but instead are due to overdosing and overprescribing to a
largely unstudied swath of patients. As many as 450,000 American patients are
taking the drugs, which can cost $1,000 per treatment.
Many doctors prescribe the drugs to improve quality of life by helping with
the fatigue often resulting from anemia. But FDA scientists said Thursday that
no scientific studies have shown the drugs improve cancer patients' quality of
At the same time, evidence from at least two recent studies showed they may
promote tumors and cause early death, says Vinni Juneja, an agency safety
"FDA believes there should be a reconsideration of the risk to benefit
ratio ... in cancer patients," he says.
Industry scientists maintain that the drugs can improve quality of life and
don't spur cancer growth.
"We do not have data that tumor progression is an issue as a result of
erythropoietin treatment. We simply don't," says Roger M. Perlmutter, MD,
executive vice president of Amgen, which sells Epogen.
But agency officials and experts blamed aggressive industry marketing for
promoting the drugs as a way to boost energy -- a claim not approved by the
Television and print advertisements widely distributed by Procrit maker
Johnson & Johnson urged patients to seek out the drug as a way to improve