FDA issues new warnings on anemia drugsMar 9, 2007 | AP
Federal health officials issued stern new warnings Friday for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease.
At issue are drugs sold under the brand names Procrit, Epogen and Aranesp. These drugs are genetically engineered versions of a natural protein, erythropoietin, that increases the number of red blood cells.
Anemia is common with certain forms of kidney disease, especially once a patient is on dialysis, and when cancer patients take chemotherapy.
But the Food and Drug Administration pointed to recent studies that found using too much of the drugs increased the risk of death, blood clots, strokes and heart attacks in patients with chronic kidney failure. In other studies, patients with head and neck cancer had more rapid tumor growth if they used higher-than-recommended doses.
Even when the anemia drugs were used at FDA-recommended doses, giving them to cancer patients not on chemotherapy increased the risk of death, the agency warned. Moreover, some doctors have begun giving the drugs to patients following orthopedic surgery, also increasing the risk of blood clots, FDA said.
Friday, the agency added stern warnings to each of the drug's labels urging that:
- doctors monitor patients' levels of red blood cells and use the lowest possible dose to avoid the need for blood transfusions.
- doctors and patients carefully weigh the risks of using anemia drugs vs. the risk of a transfusion if anemia gets too bad.
Amgen Inc. and Johnson & Johnson, companies that manufacture and market the drugs, both said they would work to inform doctors about the new warnings, outlined in a so-called "black box." The warnings are the most serious a drug label can bear.
"Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice," said Dr. Roger Perlmutter, Amgen' s executive vice president of research and development.
The FDA also said it would take a new look at how the drugs are marketed, including claims they can improve the quality of life of cancer patients. The Web site for Procrit, for example, says the drug "helps you find the strength you need."
"With the new label being revised today, we will certainly evaluate any marketing claims and revise them as needed," said Stephanie Fagan, a spokeswoman for J&J's Ortho Biotech Products LP.
A panel of FDA advisers is scheduled to discuss the drugs at a May 10 meeting. Their recommendations could lead to further revisions of the drugs' labels, FDA officials said.
In December, lawmakers and some experts raised concerns that Medicare's payment system encouraged overuse of Epogen, endangering patient lives and wasting taxpayer money. FDA officials said they would forward the recent data on the class of drugs to the Centers for Medicare and Medicaid Services.
The three drugs are huge sellers, with combined 2006 U.S. sales of $10 billion, according to IMS Health Inc.