Acting on growing safety concerns, the FDA on Tuesday ordered strict new procedures on the prescribing and dispensing of medication that treats anemia in cancer patients undergoing chemotherapy.
The new strictures ordered by the FDA affect a class of drugs called erythropoiesis-stimulating agencts, which rev up the production of red blood cells that are often depleted by cancer-fighting therapies, as well as certain drugs that treat HIV/AIDS. The drugs are sometimes given to surgical patients in an effort to reduce their need for blood transfusions and are prescribed to patients with chronic kidney disease, who often suffer anemia.
Marketed under the brand names Procrit, Epogen and Aranesp, these biologic agents can now be prescribed and dispensed only after hospitals and physicians prescribing them have certified that patients have been apprised of the drugs' risks. Several new studies have found that cancer patients and others taking this class of medications have had higher rates of tumor growth and of heart attack, heart failure, stroke or bloodclots than patients who are not on the medication. Compared with patients not on medication, patients taking the erythropoeisis-stimulating agents (or ESAs) overall have been found to die sooner as well.
The biotechnology company Amgen, whichs makes Aranesp, Epogen and Procrit (although Procrit is marketed by Johnson & Johnson Pharmaceuticals), is expected to establish a training program for physicians and hospitals wishing to prescribe any of the ESAs and to track data on their use.
The new policy follows by less than five weeks the publication of an editorial in the New England Journal of Medicine which outlines the welter of clinical trials that have turned up evidence for concern over the safety of ESAs. The editorial concludes that the medical community should reconsider its widespread use of these medications until clinical trials have established safer guidelines for their use. Among the authors of the editorial was Dr. Robert Temple, acting director of the FDA's office of drug evaluation.
The medications have been widely advertised to patients as a means of improving energy and quality of life during cancer treatment.
— Melissa Healy