- SIGNS OF STROKE: Call 911 if you experience pain or swelling in the face or a limb, sudden shortness of breath, sudden confusion or loss of balance, a cough, sometimes with blood, and pain when you inhale.
The anemia drugs epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) are among the top-sellers in the U.S., as consumers and their insurance companies spent $7.2 billion in 2008 on this class of drugs alone, while costing Medicare more than any other medication in 2007. But recent research has shown that these drugs, called erythropoiesis-stimulating agents (ESAs), can trigger deadly blood clots, make some cancers grow faster, and increase the overall death rate in certain patients. And while they can reduce the need for blood transfusions in anemic patients, there's no firm evidence that they ease symptoms or improve the quality of life.
The Food and Drug Administration recently issued a black-box-warning, the strongest type, about those risks while narrowing and re-defining the approved uses. If you and your doctor are considering the use of one of those drugs, you need to understand the potential risks, and participate actively in making the decision.
ABCs of ESAs
These drugs are synthetic versions of a hormone, normally produced by healthy kidneys, that stimulates bone marrow to produce oxygen-bearing red blood cells. If you have too few red cells—signaled by a hemoglobin level less than about 13 grams per deciliter (g/dL)--you are anemic. That may make you feel tired and weak. ESAs are FDA approved mainly to treat anemic patients with low hemoglobin caused by cancer chemotherapy or kidney disease. And, ESAs can be used before surgery to prevent anemia when significant blood loss is expected, to reduce the need for a transfusion, which may carry a slight risk of viral infection. In addition, the drugs may be used to treat anemia from other causes, even though the FDA hasn't approved such uses.This drug safety alert is made possible through a partnership between Consumer Reports Best Buy Drugs and The Research on Adverse Drug Events and Reports (RADAR) group, a pharmacovigilance group led by Charles Bennett, MD PhD MPP. This is the second in a series of reports based on research by the RADAR group.
These materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).
If you think you have experienced an adverse event with this drug or any drug, especially if it is of a serious nature, it is important to 1) tell your doctor immediately and 2) report the event to the Food and Drug Administration via the FDA's MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by calling 1-800-FDA-1088.
