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On 03/09/2007, the FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs. These research studies were evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. FDA believes these new concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have changed the full prescribing information for these drugs to include a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs.
Anemia is a condition caused when the body produces too few red blood cells. This condition can be caused by a large number of factors, including disease, improper diet, pregnancy, and genetic disorders. Chronic anemia can become a serious threat to the health of an individual if left unchecked, for it can cause lethargy, behavioral irregularities, and aggravation of chronic pulmonary disease.
Modern medicine has developed several drugs that can attempt to combat anemia, but unfortunately these drugs have many severe side effects. Drugs such as Aranesp, Epogen, and Procrit have been known to adversely affect the people who take them.
Aranesp is an anti-anemia drug used to treat victims of chronic renal failure. Patients with this disease often cannot generate enough of the proteins necessary to create enough red blood cells, so Aranesp artificially creates the conditions to stimulate red blood cells.
There are many side effects of using Aransep. Some common side effects include infection, hypertension, hypotension, and a potentially condition called red blood cell aplasia. This condition causes white blood cells to attack and destroy the bone marrow, weakening the already damaged red blood cell production center.
In January 2005 the Food and Drug Administration and Amgen, the company who makes Aranesp, alerted healthcare professionals to new updates to the potential dangers of the drug. These new precautions were intended to warn of the risks of prescribing Aransep for off label uses.
Aranesp is well known for causing a large number of serious side effects, including hypotension, fever, nausea, chest pains, and muscle pain. Because it affects the way the body generates red blood cells, there is also a significant danger of cardiac arrest, strokes, congestive heart failure, and myocardial infarction. It can also cause a condition called red blood cell aplasia, a disease that destroys the bone marrow in some people.
Epogen is an anti-anemia drug intended to restore the proper amount of red blood cells to people undergoing dialysis due to renal failure. Victims of this condition cannot usually produce enough red blood cells to maintain their health, so drugs such as Epogen help stimulate their bodies into producing sufficient amounts of blood.
Epogen can be responsible for a number of side effects. These effects include hypotension, headache, nausea, fatigue. In rare cases it causes a condition called red blood cell aplasia, which causes white blood cells to attack and destroy the bone marrow. Because people take Epogen to increase their red blood cells, destruction of the bone barrow negatively affects their already weakened condition.
Epogen is an anti-anemia drug that is used to counteract the red blood cell depleting processes common to kidney dialysis or chemotherapy treatment. These medical procedures often interfere with the way the bone marrow produces red blood cells, so Epogen artificially stimulates the bone marrow into creating new red blood cells.
Unfortunately, drugs like Epogen have been known to cause a number of potentially serious side effects. Some people have experienced allergic reactions such as hives, seizures, and rashes. More serious side effects include severe headaches, increased heart rate, fatigue, and muscle aches.
Procrit is an anti-anemia drug used to treat the loss of red blood cells caused by invasive chemotherapy and dialysis for renal failure patients. The body cannot function properly without red blood cells because these structures are responsible for distributing oxygen to every cell throughout the body. Procrit uses artificial hormones to stimulate the bone marrow to produce more red blood cells.
Unfortunately, the hormones in Procrit are known to cause severe side effects in some people. These side effects include headaches, high blood pressure, fatigue, nausea, and fluid retention. Some people even experienced severe allergic reactions such as rashes, hives and even seizures.
The anti-anemia drug Procrit is intended to encourage bone marrow to produce more red blood cells. Red blood cells are responsible for distributing oxygen to the cells of the body, but some conditions like hemodialysis and cancer chemotherapy can interfere with this natural process.
Procrit is known to cause a number of potentially serious side effects, including allergic reactions like hives, difficulty breathing, throat swelling, hives, and rashes. Rarer side effects include increased blood pressure and heart rate, nausea, and flu-like symptoms. Procrit also cause a higher than expected number of blood clots in patients during a clinical trial in 2003.
Aplasia and Red Blood Cell Damage
Aplasia is a type of anemia that affects the precursors of red blood cells. It results from a mutation in the bone marrow that prevents red blood cells from forming. Furthermore it can even cause white blood cells, the type that attack diseases, to actually assault and destroy the bone marrow to the point that it cannot generate any red blood cells at all.
Many drugs such as Procrit, Aransep, and Epogen are speculated to cause red blood cell aplasia. What complicates these situations is that these drugs are used to treat anemia, when they cause red blood cell aplasia they can cause significant further damage to the body.
The Food and Drug Administration altered doctors to developments about the popular anti-anemia drug Aransep on January 14, 2005. Studies of patients who received elevated doses of the drug to combat aggressive cancer chemotherapy exhibited unsafe numbers of potentially fatal blood clots in their circulatory systems.
Aransep stimulates the bone marrow to produce more red blood cells to replace those that are lost through cancer chemotherapy. Without red blood cells the body begins to malfunction, for these cells distribute energy to every system so that individual cells can perform their functions and reproduce. Unfortunately too many blood cells can form clots which can result in heart attacks, heart failure, and strokes.
If you have taken an anemia drug and you suffered adverse side effects you may be entitled to take legal action against those responsible. Fill out the free initial contact form and get in touch with a lawyer today.
