Erythropoiesis-Stimulating Agents (ESAs) 11.08.07- Overview
Run Time -- 00:01:25
Welcome to the Food and Drug Administration's drug safety update.
I am Mandy Eisemann from F-D-A's Center for Drug Evaluation and Research.
On November 8, 2007, we issued a public health advisory about revisions to the product labeling for the erythropoiesis- [eh RITH ro POH eh sis] stimulating agents, known as E-S-As.
The advisory alerts patients and health-care providers that we have approved revised labeling for the ESAs. The revisions clarify how to safely and effectively use these products and strengthen the information about risks from using E-S-As.
The advisory applies patients taking E-S-As who have cancer or chronic kidney failure or who are taking zidovudine [zye DOE vue deen] for H-I-V.
To hear the full public health advisory, listen to part two of this Podcast.
We are asking health care professionals and patients to report serious side effects after using E-S-As to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot G O V slash M-E-D-W-A-T-C-H.
Date created: November 8, 2007
Erythropoiesis-Stimulating Agents (ESAs) 11.08.07 - Overview mp3(MP3 - 667KB) Erythropoiesis-Stimulating Agents (ESAs) 11.0807 - Full Version Public Health Advisory: Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (marketed as Procrit and Epogen), Darbepoetin alfa (marketed as Aranesp)