The U.S. Food and Drug Administration (FDA) has warned the public that the anti-anemia drug darbepoetin alfa—sold under the brand name Aranesp—might cause life-threatening heart-related side effects and worsen cancer.
What Is Aranesp? When Is It Prescribed?
Aranesp is the brand name for the drug darbepoetin alfa. Made and sold by Amgen, Inc., a U.S. pharmaceutical company, this prescription medication is used to treat anemia brought on by chronic kidney disease (CKD) or concomitant myelosuppressive chemotherapy that will last at least an additional two months. The FDA approved the drug in 2001, and Amgen sells it in the form of intravenous and subcutaneous injections.
Darbepoetin is a hormone similar to a naturally occurring one called erythropoietin (EPO). When the kidneys detect reduced oxygen levels in the blood, they secrete EPO, which stimulates the body’s creation of red blood cells. By injecting a similar compound into patients’ bodies, medical professionals can counteract symptoms of anemia, a condition characterized by a shortage of red blood cells.
Aranesp is not without controversy, however. Because it can stimulate red blood cell formation, it is sometimes used by athletes as a performance enhancing drug. More seriously, in late 2012, Amgen plead guilty to illegally marketing Aranesp to cancer patients who were not undergoing chemotherapy, a condition for which the FDA specifically forbade Amgen from marketing the drug. According to the New York Times, Amgen agreed to pay $762 million with $136 million going to criminal fines, $14 million to forfeitures, and $612 million to settle 11 whistleblower lawsuits. The Times reported that a federal prosecutor accused Amgen of leading its salespeople to believe Aranesp was approved to treat off-label uses.
At its height, Aranesp sales were worth $4 billion, but they began declining in 2007 due to reports of serious adverse side effects.
Aranesp Might Cause Deadly Side Effects
In February 2010, the FDA issued an Aranesp drug safety communication warning the public that studies had shown that Aranesp use could increase the risk of tumor growth and cause heart-related problems. The FDA required Amgen to create a risk evaluation mitigation strategy to prevent Aranesp injuries. The FDA Aranesp warning was based on no fewer than eight studies showing that the drug reduced cancer patient survival rates.
In June 2011, the FDA issued a second Aranesp drug safety communication that recommended reducing the drug’s dosage when used to treat CKD. This Aranesp warning was based on three studies of people with CKD who used the drug and suffered some kind heart-related problem or death. The agency’s analysis found that use of Aranesp corresponded to an increased likelihood of those events, prompting the communication.
The FDA’s Aranesp drug label states: “Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.”
Symptoms of Aranesp-related side effects include:
- Blood clots
- Heart attack
- Heart failure
- Faster tumor growth (for cancer patients)
- Early death
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Aranesp lawsuit on your behalf if necessary.
If you or a loved one has taken Aranesp, and you believe it caused an injury, contact RLG today.