A new study published in the Journal of the American Medical Association (AMA) reports that cancer patients taking Ortho Biotech’s (a Johnson & Johnson company) Procrit and Amgen Inc.’s Aranesp, both anemia drugs used to treat weakness and fatigue caused by kidney disease and side effects of chemotherapy, may increase the risk of blood clots and death.

The study

The study, which was conducted over 20 years and on 13,600 patients in 51 clinical trials, showed that approximately 7.5 percent of cancer patients who were given the drugs developed blood clots (a 57 percent increase from those given placebos) and were at a 10 percent higher risk of death. The FDA will review the latest study on March 13, 2008 to determine if further steps should be taken.

Drug details

Procrit. The FDA approved Procrit, also known as erythropoiesis-stimulating agents (ESAs) and marketed as Epogen, for treatment of cancer patients in 1993 as it reduced the need for patients to undergo blood transfusions. According to the manufacturer, Ortho Biotech:

Procrit is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal [kidney] failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine [a drug used to treat infection] for HIV [Human immunodeficiency virus] . . . and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery.

Aranesp. The FDA approved Aranesp, also known as erythropoiesis-stimulating agents (ESAs), for treatment of cancer patients in 2002 as it reduced the need for patients to undergo blood transfusions. According to the manufacturer, Amgen:

Aranesp is approved in the United States, most countries in Europe, Canada, Australia, and New Zealand for the treatment of anemia associated with chronic renal failure in patients both on dialysis and not on dialysis.

FDA reevaluated use in 2007

The FDA reevaluated the use these drugs in March 2007. According to an FDA press release:

Recent reports of studies with erythropoiesis-stimulating agents (ESAs) have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents. ESAs stimulate the bone marrow to make more red blood cells and are FDA approved for use in reducing 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 that are using AZT.

If you or a loved one has been injured due to use of these drugs, contact an attorney to discuss your situation. The consultation is free, without obligation and strictly confidential. To contact a qualified attorney whose practice focuses in this area of law, please click here.