Erythropoiesis-Stimulating Agents (ESAs)
The dangerous drug attorneys working with the Law Offices of Gregory Krasovsky provide legal support and representation to plaintiffs seeking to pursue an Erythropoiesis-Stimulating Agent lawsuit. In order to secure a maximum Erythropoiesis-Stimulating Agent settlement, it is crucial to have a competent and experienced Erythropoiesis-Stimulating Agent lawyer to guide you through all of the legal hurdles. Contact an Erythropoiesis-Stimulating Agent attorney today to schedule a free consultation and take your first step to recovering damages.
An Erythropoiesis-Stimulating Agent is a drug that is a genetically engineered version of the naturally 0ccuring protein erythroprotein, which causes an increase in the amount of red blood cells. Erythropoiesis-Stimulating Agents are used in a variety of different drugs, but the three most common drugs are Aranesp, Epogen, and Procrit, which are all used to treat anemia in patients suffering either from kidney failure or from anemia caused by chemotherapy in cancer treatment. Aranesp and Epogen are both manufactured and marketed by Amgen, while Procrit is marketed by Janssen Pharmaceuticals.
Anemia is a disorder in which there occurs a decrease of red blood cells. It is a type of hemoglobin deficiency. When anemia is caused by kidney complications or by chemotherapy, Epogen, Procrit, and Aranesp can be used to stimulate the growth of more red blood cells, and by extension, these drugs increase the amount of oxygen that reaches the bloodstream, which mitigates anemia. Ultimately, these drugs are supposed to decrease the amount of blood transfusions a patient is supposed to get; however, some studies have shown that these drugs do not reduce the net amount of blood transfusions given to these patients.
The larger issue with these drugs is the potential for causing debilitating side effects. Erythropoiesis-Stimulating Agent adverse effects include the following:
- Heart Attack
- Deep Vein Thrombosis
- Stroke
- Blood Clots
- Bone Pain
- Nausea
- Retinopathy of Prematurity (in infants)
- Death
In effect, there are concerns that Erythropoiesis-Stimulating Agents might mitigate the effects of anemia, but exacerbate the harmful effects of cancer or kidney disorders. Most notably, these drugs have been linked to an increase in the rate of tumor progression in patients who had been suffering from a variety of cancers. Additionally, these drugs significantly increased the chance of blood clots for patients who were not suffering from any cancer, but had just undergone orthopedic surgery.
ESAs and Cancer
Erythropoiesis-Stimulating Agents are thought to have a link with worsening cancer conditions. Namely, studies have shown that tumour growth progresses more quickly in patients taking Erythropoiesis-Stimulating Agents than it does in patients who have not had them administered. Additionally, survival time of patients may have been shortened as a result of taking Erythropoiesis-Stimulating Agents in patients who had cervical cancer, non-small cell lung cancer, head and neck cancer, and breast cancer.
Loco-regional cancer control was also significantly worse in patients who were prescribed Aranesp tahn for those who have not been prescribed Aranesp.
Amgen, in regard to Epogen, have written the following warning concerning cancer:
"ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers."
It was in response to these studies that the FDA issued a series of warnings to the public and to doctors about the risks of taking Erythropoiesis-Stimulating Agents.
History of ESAs and FDA Black Box Warnings
Since at least 2007, Amgen and the FDA have been aware of the potentially harmful effects of these drugs. In 2007, Amgen warned doctors about administering Erythropoiesis-Stimulating Agents for off-label uses. Amgen had also warned the FDA about the potential effects its drugs might have on loco-regional cancer control. In other words, cancers were possibly exacerbated as a result of the administration of these drugs.
Subsequently, the FDA released a clinical advisory for doctors in February 2007 and a Public Health Advisory on March 9, 2007, which warned about the use of ESAs. Basically, the report stated that there was not sufficient evidence that these drugs neither improved the quality of life of patients nor did they reduce transfusion requirements.
Amgen and other manfucturers agreed to place a Black Box Warning on these drugs. In 2011, the Black Box Warning was further revised to say that ESAs should only be used to treat anemia for chemotherapy patients and not for patients suffering from anemia for other reasons. Additionally, the Warning states that because of the risk of ESA side effects, the lowest possible dose should be administered.
Erythropoiesis-Stimulating Agents all use the following generic name – Epoetin Alfa – and are marketed under the following names:
If you or a loved one has been injured as a result of taking a Erythropoiesis-Stimulating Agent (ESAs), you might be entitled to compensation. Doctors who prescribe Erythropoiesis-Stimulating Agents without giving the patients sufficient warning of the side effects may be committing medical malpractice. Additionally, if a doctor continues to prescribe a drug like Procrit or Aranesp after ESA adverse effects are manifesting themselves, he or she may be acting in a negligent fashion.
Contact a dangerous drug lawyer or a medical malpractice lawyer today to schedule a free and confidential consultation. Our expert legal advice can be just what you need to reclaim compensation for your pain and suffering.
