Anemia drug linked to Blood Clots, death in
Cancer Patients
Newswise — Treating anemia with a class of drugs known as
erythropoiesis-stimulating agents (ESAs) is
associated with an increased risk of venous
thromboembolism (blood clots in the deep
veins of the legs or in the lungs) and death
among patients with cancer, according to an
article in the February 27 issue of JAMA.
The ESAs erythropoietin and darbepoetin are widely used to
treat anemia in patients with cancer.
Some studies have indicated that there may be a higher risk
of venous thromboembolism (VTE) with these
medications, but it has not been known if
there is an associated increased risk of
death, according to background information
in the article.
Charles L. Bennett, M.D., Ph.D., of the Northwestern
University Feinberg School of Medicine,
Chicago, and colleagues examined the rate of
VTE and death associated with ESA
administration for treatment of anemia among
patients with cancer by conducting a review
of phase 3 trials.
The researchers identified 51 clinical trials with 13,611
patients to examine survival. Analysis of
the data indicated that the risk of death
was significantly higher for patients with
cancer who were treated with ESA vs. the
control (placebo) group.
Venous thromboembolism was evaluated for 38 trials that
included 8,172 patients. The researchers
found that there was a significantly
increased risk (57 percent) of VTE among
patients treated with ESA (334 events among
4,610 patients treated with ESA vs. 173
events among 3,562 control patients).
“These risks are important given the prevalence of ESA use as
a supportive care drug among patients with
cancer as well as the dissemination of a
series of safety advisories by the Food and
Drug Administration (FDA) and ESA
manufacturers,” the authors write.
“Safety concerns account in large part for changes observed
in patterns of use, reimbursement policies,
clinical guidelines, and FDA-approved
package inserts pertaining to ESAs in the
oncology setting. Our findings, in
conjunction with basic science reports on
erythropoietin and erythropoietin receptors
in solid cancers, raise concern about ESA
safety for patients with cancer.”