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FDA Drug Safety Podcasts
Transcript [music] Welcome to the Food and Drug Administration's drug safety update. I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research. On March 9, 2007, we issued a public health advisory to alert you that recent reports of studies with the use of Erythropoiesis [ee-RITH-row-poe-EE-sis] -stimulating agents (or ESAs) have shown a higher chance of serious and life-threatening side effects and a greater number of deaths in patients treated with these agents. Marketed under the trade names Aranesp, Epogen and Procrit, ESAs stimulate the bone marrow to make more red blood cells. We have approved them for use in reducing the need for blood transfusions in patients with chronic kidney failure, cancer patients on chemotherapy, patients scheduled for major surgery (except heart surgery) and patients with HIV who are using AZT. Because all ESAs work the same way, the findings from these studies apply to all ESAs. We are re-evaluating the safe use of ESAs. FDA and Amgen, the manufactuer of the three ESA-agents, have changed the full prescribing information for these drugs. The new product labeling includes a new boxed warning, updated warning, and change to the dosage and adminstration sections for all ESAs. We are asking health-care professionals to report serious adverse events in connection with ESAs 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 MedWatch. To hear the full public health advisory, listen to part 2 of this broadcast. Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site F-D-A dot G-O-V slash C-D-E-R. [music] Additional Information
Date created: March 13, 2007 |
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