Erythropoiesis-Stimulating Agents (ESA’s) are used in the treatment of patients diagnosed with anemia who are also suffering from chronic kidney disease (CKD). However, recent evidence suggests that ESA’s may be responsible for severe, life-threatening complications. As a result, the U.S. Food and Drug Administration (FDA) has recommended a more conservative approach in using these medications because of their elevated risks of cardiovascular events such as stroke, heart attack, deep venous thrombosis, and death.
If you or a loved one has been injured by an Erythropoiesis-Stimulating Agent, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
What’s the problem?
The U.S. Food and Drug Administration approved of the use of Erythropoiesis-Stimulating Agents because of their inherent ability to treat the symptoms of anemia that have been triggered by chronic kidney disease, chemotherapy, and a number of other conditions.
Erythropoiesis-Stimulating Agents are a synthetic version of a human protein known in the healthcare community as an erythropoietin. Erythropoietin initiates the stimulation of primitive cells in bone marrow to produce red blood cells, which are considered the prominent oxygen-carrying cells in the entire bloodstream. Blood hemoglobin, the laboratory measure of the number of red blood cells in the blood, is significantly low in the presence of anemia. Therefore, by stimulating the production of red blood cells, Erythropoiesis-Stimulating Agents increase the amount of oxygen in the bloodstream to combat anemia.
Unfortunately, Erythropoiesis-Stimulating Agents may not promote a favorable risk-benefit profile. ESA’s may increase the risk of a patient developing cardiovascular events such as stroke, heart attack, deep venous thrombosis, and death. As a result, the FDA has recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents when used to treat anemia in patients with chronic kidney disease. Due to the severity of these catastrophic side effects, many patients may seek compensation for their pain and suffering by filing a Erythropoiesis-Stimulating Agent lawsuit.
Erythropoiesis-Stimulating Agent Side Effects
The following is a list of Erythropoiesis-Stimulating Agent side effects:
- Heart attack
- Deep venous thrombosis
Due to the severity of these catastrophic side effects, many patients may seek compensation for their pain and suffering by filing a Erythropoiesis-Stimulating Agent lawsuit.
Brand Name ESA’s
ESA’s currently on the U.S. market include the following brand names:
These brand name medications are currently being investigated for Erythropoiesis-Stimulating Agent lawsuits.
FDA Label Change
The following FDA news release illustrates the dangers associated with taking Erythropoiesis-Stimulating Agents:
Modified recommendations are being added to the Boxed Warning and other sections of the package insert in response to clinical trials showing an increased risk of cardiovascular events, such as heart attack and stroke, when ESAs are dosed to achieve a normal or nearly normal blood hemoglobin level.
The modified recommendations for dosing ESAs in patients with CKD are based on data from clinical trials including TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy), which showed that using ESAs to target a hemoglobin level of greater than 11 g/dL increased the risk of serious adverse cardiovascular events, such as heart attack and stroke, and provided no additional benefit to patients. Due to the severity of these catastrophic side effects, many patients may seek compensation for their pain and suffering by filing a Erythropoiesis-Stimulating Agent lawsuit.
In addition to revising the package, the FDA is issuing a Drug Safety Communication informing health care professionals about its modified recommendations and issuing a response to a related Citizen Petition. The FDA will continue to evaluate the safety of ESA’s.
Do I Have A Erythropoiesis-Stimulating Agent Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Erythropoiesis-Stimulating Agent lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by an Erythropoiesis-Stimulating Agent, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.