| March
9, 2007--The
FDA has issued a public health advisory outlining new
safety information about erythropoiesis-stimulating agents
(ESAs), which are widely used for the treatment of anemia.
Drugs affected by the safety update are darbepoetin alfa (Aranesp)
and epoetin alfa (Epogen and Procrit).
The
FDA and the drugs' manufacturer, Amgen, have agreed on
revised product labeling that includes updated warnings, a
new boxed warning, and modifications to the dosing
instructions.
Recently
completed studies describe an increased risk of death,
blood clots, strokes, and heart attacks in patients with
chronic kidney failure when ESAs were given at higher than
recommended doses. In other studies, more rapid tumor
growth occurred in patients with head and neck cancer who
received these higher doses.
In
studies where ESAs were given at recommended doses, an
increased risk of death was reported in patients with
cancer who were not receiving chemotherapy and an
increased risk of blood clots was observed in patients
following orthopedic surgery. FDA
News
|
