The Food and Drug Administration is considering new limits on widely used anemia drugs that emerge to double the risk of stroke in patients with kidney disease. The FDA posted its safety appraisal of the three blood boosting medications from Amgen Inc. on Thursday, focusing on their use in patients with chronic kidney disease who are not yet sick sufficient to receive dialysis. The medicines Procrit, Aranesp and Epogen are multibillion dollar sellers because of their capability to boost oxygen-carrying red blood cells, reducing the require for painful blood transfusions. But sales have fallen stridently since 2007, when the FDA added the first of many safety warnings to the drugs, based on evidence they can cause tumor enlargement and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers.
Anemia, which causes weakness and smallness of breath, is a side result of chemotherapy and kidney failure. Now the FDA is review a study published last year that show kidney disease patients taking Aranesp were twice as likely to knowledge stroke compare with those taking a dummy treatment. The goal of the study was to show that the drug could avoid heart attack, stroke and other heart related problems, as had been assumed for years. But FDA reviewers, using the chemical name for Aranesp, said in their posting that the "proof raises considerable doubt about the safety and desirability of using darbepoetin in this manner."
Amgen has argued that its drugs should carry on to be used because they help avoid blood transfusions, which carry their own risks. But the FDA's scientists point out that 15 percent of patients who took the company's drug still wanted transfusions, compared with 25 percent of those taking a placebo treatment. "Treatment did not eliminate the risk of need transfusions," states the FDA review. On Monday the agency will ask a panel of outside expert to review the data and create recommendations on how to safely use the drugs. Panelists could recommend bolstered warning labels, extra studies or lower doses of the drugs. The FDA is not necessary to follow the group's advice, although it often does.
useful links : transport rankings
Anemia, which causes weakness and smallness of breath, is a side result of chemotherapy and kidney failure. Now the FDA is review a study published last year that show kidney disease patients taking Aranesp were twice as likely to knowledge stroke compare with those taking a dummy treatment. The goal of the study was to show that the drug could avoid heart attack, stroke and other heart related problems, as had been assumed for years. But FDA reviewers, using the chemical name for Aranesp, said in their posting that the "proof raises considerable doubt about the safety and desirability of using darbepoetin in this manner."
Amgen has argued that its drugs should carry on to be used because they help avoid blood transfusions, which carry their own risks. But the FDA's scientists point out that 15 percent of patients who took the company's drug still wanted transfusions, compared with 25 percent of those taking a placebo treatment. "Treatment did not eliminate the risk of need transfusions," states the FDA review. On Monday the agency will ask a panel of outside expert to review the data and create recommendations on how to safely use the drugs. Panelists could recommend bolstered warning labels, extra studies or lower doses of the drugs. The FDA is not necessary to follow the group's advice, although it often does.
useful links : transport rankings
No comments:
Post a Comment