FDA strengthens boxed warnings for high profile drugs-Avandia, and ESAs Aranesp, Epogen, and Procrit.
The US Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) has added and strengthened boxed warnings for two high profile drugs - the Anti-Diabetes drug Avandia, manufactured by GlasoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) ), Philadelphia, PA, and the drugs Aranesp, Epogen and Procrit, manufactured by Amgen, Inc., Thousand Oaks, CA. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, NJ, a subsidiary of Johnson & Johnson.
Avandia's black box warning, which is used to treat type 2 diabetes type 2 diabetes
See diabetes mellitus. , will have new information about the potential increased risk for heart attacks. The FDA says people who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. The FDA also advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.
The revision of Avandia's existing boxed warning - FDA's strongest form of warning - includes the following statement:
"A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart.
pertaining to the muscular tissue of the heart (the myocardium). ischemic Ischemic
An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery.
Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation
ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive."
The FDA approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs) which treat certain types of anemia. The new statements address the risks the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure Chronic Kidney Failure Definition
Chronic kidney failure occurs when disease or disorder damages the kidneys so that they are no longer capable of adequately removing fluids and wastes from the body or of maintaining the proper level of certain .
For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and serious cardiovascular reactions such as stroke, heart attack or heart failure.
In addition to the box warning, the new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not response to ESA treatment with an adequate increase in their hemoglobin levels.
The new labeling also emphasizes that there are no data from controlled trials demonstrating that ESAs improve symptoms or anemia, quality of life, fatigue, or patient well-being for patients with cancer or for patients with HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. undergoing AZT AZT or zidovudine (zīdō`vydēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called therapy.
For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer Lung Cancer, Non-Small Cell Definition
Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors.
There are two kinds of lung cancers, primary and secondary. when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter deciliter /dec·i·li·ter/ (dL) (des´i-le?ter) one tenth (10minus;1) of a liter; 100 milliliters.
100 cubic centimeters (cc).
Mentioned in: Hypercholesterolemia (g/dL) or greater.
The boxed warnings also emphasize that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive ESA dose that attempts to achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level commonly achieved in clinical practice.