The FDA has expanded warnings about risks of death and tumor growth in relation to use of Erythropoiesis Stimulating Agents (ESAs). ESAs are used to treat the blood-disorder anemia in patients with kidney failure or who are undergoing chemotherapy.
The new warnings approved Friday by the Food and Drug Administration warn that the drugs increase death and accelerate tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling added to the drugs in November warned of similar risks in other types of cancers.
The warnings apply to drugmaker Amgen's Aranesp and Epogen, as well as Procit, sold by Johnson & Johnson.
Labeling approved by FDA said risks occurred when doctors treated patients with elevated levels of the drugs, which stimulate red blood cell levels.
The action by FDA and the drugmakers comes less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications.
If you or a loved one has suffered these serious complications as the result of taking ESAs, you may be entitled to compensation. For a free legal consultation, contact us today!