As a defective prescription drug attorney, I am familiar with at least one older study linking a class of anemia drugs to potentially life-threatening blood clots. On Nov. 10, a study to be published in the Dec. 2 Journal of the National Cancer Institute confirmed that link. According to a Nov. 10 article from HealthDay, the study found that a class of drugs called erithropoiesis-stimulating agents (ESAs) doubled the risk of blood clots in cancer patients receiving the drugs during chemotherapy. Of those patients, 14.3% developed thromboembolism (blood clots big enough to block blood flow), while 9.8% of those not receiving an ESA developed it.
ESAs are typically prescribed to people undergoing chemotherapy — of which anemia can be a side effect — or people with chronic kidney disease. Common brand names for these drugs include Procrit, Epogen (both epoetin alfa) and Aranesp (darbepoetin alfa). They were approved in the late 1990s to reduce the need among chemotherapy patients for blood transfusions and are now widely prescribed. According to the article, U.S. ESA sales were $10 billion in 2006, and Medicare spent more on ESAs than on any other drug. However, the new study found no difference in number of transfusions between patients receiving ESAs during chemotherapy and chemotherapy patients not taking the drugs. Survival rates were also similar.
However, patients taking ESAs had an higher risk of developing veinous thromboembolism — blood clots in veins big enough to block at least some blood flow. Specifically, they had a higher rate of pulmonary embolism and deep vein thrombosis, both of which can cause life-threatening complications. When a blood clot passes into the lungs in a pulmonary embolism, it can cause breathing problems, heart palpitations, abnormally low blood pressure, collapse and sometimes death. Deep vein thrombosis that doesn’t result in a pulmonary embolism can still cause swelling, pain and skin problems. Because of the risk of death, both are considered medical emergencies.
As a dangerous medication lawyer, I’m not sure whether it’s more disturbing that these drugs can cause sudden death from pulmonary embolism — or that they don’t appear to do what they were approved to do. The study’s lead author, Dr. Dawn Hershman of the Herbert Irving Comprehensive Cancer Center in New York, said her results raise questions about the approval process and post-marketing research for ESAs. After the first studies connecting ESAs with blood clots, the Food and Drug Administration added a black box warning to their labels — the most serious warning available — disclosing the risk of blood clots and death and suggesting limitations on which patients should receive them. With this new study, I hope doctors and regulators seriously consider whether chemotherapy patients truly need an ESA before prescribing one.
Based in St. Louis, the Lowe Law Firm represents clients injured by a prescription drug in Missouri, Illinois and throughout the United States. When we’re given prescription drugs by our doctors, we should be able to trust that those drugs are safe to use as directed. Unfortunately, a long history and my own experience as a pharmaceutical injury attorney has shown that not all drugs are safe — and some manufacturers even take steps to suppress safety information that could hurt their drugs’ sales, even when patients are hurt. Patients who suffer death or serious health consequences from such a drug can and should hold manufacturers legally responsible for the results. That includes all of the financial costs of the injury, such as health care bills or funeral costs, as well as compensation for their injuries, pain, suffering and any wrongful death or permanent disability.
If you or a loved one has been seriously injured by a prescription drug you thought you could trust, the Lowe Law Firm would like to help. To learn more about your legal options at a free consultation, please call us toll-free anytime at 1-877-678-3400 or contact us through our Web site.