Restrictions on widely used anaemia drugs are being reviewed by the Food and Drug Administration (FDA) after a study suggested they double the risk of stroke among patients with kidney disease.
Three of Amgen Inc’s blood-boosting drugs have been the subject of an FDA safety review, which concentrated on their use in patients who have chronic kidney disease but are not yet sick enough to be given dialysis.
Aranesp, Epogen and Procrit reduce the need for blood transfusions by increasing the count of oxygen-carrying red blood cells. However, after the FDA issued the first of a number of safety warnings on the drugs in 2007, because evidence suggested they can cause tumour growth and hasten death in cancer patients, sales declined sharply.
Patients with several types of cancer are no longer given the drugs.
Anaemia, which causes weakness and shortness of breath, is a side effect of chemotherapy and kidney failure.
Now the FDA is reviewing a study published last year that showed kidney disease patients taking Aranesp were twice as likely to experience stroke compared with those taking a dummy treatment. The goal of the study was to show that the drug could prevent heart attack, stroke and other heart-related problems, as had been assumed for years.
Copyright Press Association 2010