Anemia Drugs Under FDA Scrutiny – Again

The popular anemia drugs Epogen, Aranesp and Procrit are under FDA (U.S. Food & Drug Administration) scrutiny yet again. In reaction to a recent clinical trial published in the New England Journal of Medicine (NEJM) which highlighted the safety of these drugs, the FDA says that it will again scrutinize how these drugs are used.

Epogen, Aranesp & Procrit: What are they and why are they dangerous?

Epogen, Aranesp and Procrit are anemia drugs known as erythropoiesis-stimulating agents (ESAs) which raise the body's level of red blood cells. Here's a bit more on each:

• Epogen. Approved by the FDA in 1999, Epogen (epoetin alfa) is manufactured by Amgen for the treatment of anemia associated with chronic renal – kidney – failure (CRF) in patients who are undergoing dialysis.
• Aranesp. Approved by the FDA in 2002, Aranesp (darbepoetin alfa) is manufactured by Amgen for the treatment of anemia associated with CRF in patients both on dialysis and not on dialysis.
• Procrit. Approved by the FDA in 1993, Procrit (also epoetin alfa) is manufactured by Johnson & Johnson to treat anemia in patients who are receiving chemotherapy, being treated for CRF who may or may not be on dialysis, being treated with zidovudine to treat infections relating to HIV (human immunodeficiency virus) or trying to reduce the need for transfusion while scheduled for elective non-cardiac, non-vascular surgery.

In March 2007, the FDA required manufacturers to include a black box warning – the strictest warning available – on these drugs to warn:

• kidney disease patients that using the drugs to achieve higher hemoglobin levels may increase the risk of death and severe cardiovascular events which may include heart attacks and vascular thrombosis (blood clots).
• cancer patients that using the drugs to achieve hemoglobin levels above 12 g/fl may result in quicker cancer progressions and shorter survival rates in patients with advanced breast, head, neck, lymphoid and lung cancer.

Under scrutiny – again

Even with black box warnings, the FDA says that it will re-evaluate the safety of these drugs after recent clinical trial information published in the NEJM revealed that patients with chronic kidney (renal) failure had an increased risk of death, blood clots, strokes and heart attacks when used at higher doses and that cancer patients not undergoing chemotherapy had an increased risk of death when given recommended doses.

Product liability lawyers who represent those injured by Epogen, Aranesp or Procrit caution users that every state has its own statute of limitations for filing a lawsuit against drug manufacturers. Anyone who believes they have been injured should at least contact an attorney to discuss and evaluate their situation as soon as possible to determine whether they might be entitled to compensation for their injuries such as lost income, medical bills and pain and suffering.

The foregoing article has been prepared by an attorney who is a regular contributor to FreeAdvice, and is now undergoing review by the site's editorial staff.