FDA restricts use of erythropoiesis stimulating drugsBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1050 (Published 22 February 2010) Cite this as: BMJ 2010;340:c1050
The US Food and Drug Administration and a manufacturer of erythropoiesis stimulating agents have announced a new safety plan for use of these drugs in patients with cancer.
Studies found that when the drugs were used in patients with cancer they caused tumours to grow faster and led to earlier deaths in some patients (Clinical Cancer Research 2008;14:3242, doi:10.1158/1078-0432.ccr-07-1872; CMAJ 2009;180:e62-71, doi:10.1503/cmaj.090470). In April 2008 the FDA required the manufacturer, Amgen, to establish a risk management programme for these drugs.
The FDA said that such a programme was needed to ensure that the drugs’ benefits “outweigh the risks of shortened overall survival and/or increased tumour progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.”
The drugs are epoetin alfa (marketed in the United States as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), by Amgen and Centocor Ortho Biotech Products, part of Johnson and Johnson. The drugs stimulate bone marrow to produce more red cells. They are used to treat anaemia related to chemotherapy in patients with cancer.
The drugs are also used to treat anaemia in patients undergoing dialysis, people with chronic renal failure, and some other patients, but the risk management programme applies only to their use in patients with cancer.
The new risk evaluation and mitigation strategy requires health professionals to give patients receiving the drugs a guide on how to use the drugs safely.
If health professionals are giving the drugs to patients with cancer they must also participate in Amgen’s “assisting providers and cancer patients with risk information for the safe use of ESAs [erythropoiesis stimulating agents]” (APPRISE) programme, a part of the risk evaluation programme. Amgen must make sure that these health professionals maintain active enrolment in the APPRISE programme, complete a training module on how to use these drugs in cancer patients, and discuss with patients the risks, benefits, and FDA approved uses of the drugs before the patients begin treatment with them. They must also get a written acknowledgement of the discussion from the patient.
“Amgen is also required to oversee and monitor healthcare professionals and hospitals that use ESAs for patients with cancer to ensure that these caregivers are fully compliant with all aspects of the overall risk management programme,” FDA said in a statement.
Roger Perlmutter, executive vice president for research and development at Amgen, said, “This programme supports a thoughtful dialogue between healthcare providers when considering ESA treatment.”
To support the programme, Amgen and Centocor Ortho Biotech will send a letter to healthcare providers introducing the rationale for the programme, its objectives, requirements for training and enrolment, and the consequences of not enrolling. From 24 March healthcare providers who prescribe the drugs and hospitals that dispense them will be able to enrol in the APPRISE programme through its website (www.esa-apprise.com).
Cite this as: BMJ 2010;340:c1050