The U.S. Food & Administration (FDA) is reviewing the safety of anemia drugs Epogen and Aranesp – manufactured by Amgen, and Procrit – manufactured by Johnson & Johnson, as more clinical trials have shown that higher doses of the drugs may increase the risk of heart attacks and strokes. The Administration says that numerous studies “raise major concerns” about the popular drugs.
Clinical trials show increased dangers
Numerous clinical trials have suggested that Epogen, Aranesp and Procrit – anemia drugs known as erythropoiesis-stimulating agents which raise the body's level of red blood cells – may cause an increase in strokes and heart attacks and may worsen the condition of cancer patients. Anemia is a common side effect for patients undergoing chemotherapy and with chronic kidney disease. The FDA says that it will re-examine the safety of these drugs after an article was published in the New England Journal of Medicine (NEJM) suggested that a re-examination was necessary – particularly when used to target blood hemoglobin at levels below 12.
That article details a clinical trial known as TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) which was presented at the annual meeting of the American Society of Nephrology (ASN). According to the NEJM, the results of the study stated that Aranesp:
...failed to meet its primary objectives of demonstrating a reduction in all-cause mortality, cardiovascular morbidity, including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia, or end-stage renal disease (ESRD).
The FDA will create an outside advisory committee which will consider alternative measures to control dosages and re-evaluate how patients with chronic kidney disease use the epoetin alfa anemia drugs. In addition, a Medicare advisory panel will meet in March 2010 to discuss how these drugs will be covered when used by patients with kidney disease.
A re, re-evaluation
This is not the first time that the FDA has re-evaluated these controversial drugs. In March 2007, the Administration reported that the ESA drugs have, “shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents … which reduce the need for blood transfusions in patients with chronic kidney failure, patients with cancer on chemotherapy, patients scheduled for major surgery (except heart surgery) and patients with HIV (Human Immunodeficiency Virus) that are using AZT (azidothymidine).” All three drugs now carry a black box warning – the strictest warning the FDA can require – meaning that a drug carries a significant risk of serious or even life-threatening adverse effects.
Have you been injured?
If you've been injured after taking Epogen, Aranesp or Procrit, contact an experienced FDA and Drug Litigation lawyer to discuss your situation in confidence. Drug manufacturers have a duty to conduct clinical trials before releasing potentially dangerous products into the marketplace. Unfortunately, the FDA is limited in conducting its own research and oftentimes will simply accept the manufacturer's studies – leaving patients to rely on the research of giant pharmaceutical companies which do not have your best interests at heart.
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.