The report stated that anti-anemia doses in excess of the FDA's recommendations is common practice in the dialysis industry. It's known that the dialysis industry derives much of its revenue from administration of one of the anti-anemia drugs, Epogen -- which is made by Amgen, a large drug design and manufacturing company.
In addition to the recent report, an article published yesterday in the online edition of the British medical journal The Lancet went on to state that half of all kidney dialysis patients have their red blood cell counts boosted beyond what the FDA regards as a safe dosage.
Many kidney failure patients suffer from anemia -- low red blood cell counts -- and would require blood transfusions without treatment. The UK's The Globe newspaper reported in September that in addition to the fact that half of all kidney dialysis patients had their red blood cell counts pushed higher than what the FDA recommends, about 20 percent of all dialysis patients -- about 65,000 total patients -- had counts in the potential danger zone revealed in the clinical trial.
The anti-anemia drugs known commonly as Epogen and Aranesp are manufactured by Amgen and Johnson & Johnson's Procrit division. Both drugs -- which stimulate bone marrow to produce red blood cells -- are also prescribed for cancer patients undergoing chemotherapy.
The FDA alert this week also raises questions about new clinical prescribing guidelines issued by the National Kidney Foundation and underwritten by pharmaceutical companies -- including Amgen -- that suggest it is desirable to boost red blood cell counts to 13 grams per deciliter.
The limit of 12 grams per deciliter is the FDA-imposed suggested limitation and this new suggestion from the National Kidney Foundation goes beyond what the FDA states as safe. When asked, the Nation Kidney Foundation did not immediately respond to a request for comment this week, although a Foundation official stated that study's findings would be reviewed.