Safety Advisories in Anemic Cancer Patients
Amgen sent a "dear doctor" letter in January, 2007, that highlighted results from a recent anemia of cancer trial, and warned doctors to consider use in that off-label indication with caution.
Amgen advised the U.S. Food and Drug Administration (FDA) as to the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that 3-year loco-regional control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01).
In response to these advisories, the FDA released a Public Health Advisory on March 9, 2007, and a clinical Alert for doctors on February 16, 2007, about the use of erythropoeisis-stimulating agents such as epogen and darbepoetin. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings.
In addition, on March 9, 2007, drug manufacturers agreed to new "black box" warnings about the safety of these drugs. On November 8, 2007, additional "black box" warnings were included on the aranesp label, at the request of the FDA.
On March 22, 2007, a congressional inquiry into the safety of erythropoeitic growth factors was reported in the news media. Manufacturers were asked to suspend drug rebate programs for physicians and to also suspend marketing the drugs to patients.
Read more about this topic: Darbepoetin Alfa
Famous quotes containing the words safety, cancer and/or patients:
“Man gives every reason for his conduct save one, every excuse for his crimes save one, every plea for his safety save one; and that one is his cowardice.”
—George Bernard Shaw (1856–1950)
“I’m beginning to believe that Killer Illiteracy ought to rank near heart disease and cancer as one of the leading causes of death among Americans. What you don’t know can indeed hurt you, and so those who can neither read nor write lead miserable lives, like Richard Wright’s character, Bigger Thomas, born dead with no past or future.”
—Ishmael Reed (b. 1938)
“The doctor should be opaque to his patients and, like a mirror, should show them nothing but what is shown to him.”
—Sigmund Freud (1856–1939)