FDA Puts Severe Restrictions on Use of Anemia Drugs in Cancer Patients

By February 19, 2010Uncategorized

I wrote here last week about a heightened risk of death in cancer patients taking the antidepressant Paxil. This week, the FDA announced more bad news for cancer patients taking another commonly prescribed class of drugs. The agency announced Feb. 16 that it will require drug manufacturers to strictly control how three anti-anemia drugs — Procrit, Epogen and Aranesp — are prescribed and used among cancer patients. The move came after the agency spent about two years reviewing studies showing that this class of drugs, called erythropoiesis-stimulating agents (ESAs), can actually increase the risk of tumor growth and death in cancer patients. Studies have also shown that ESAs increase the risk of heart attacks, heart failure, stroke and blood clots in patients taking the drugs for other conditions.
This announcement is important for cancer patients, because ESAs are frequently prescribed to them. Cancer itself can cause anemia in some patients, and chemotherapy causes it in many others. Prior to the invention of ESAs, the Associated Press reported Feb. 16, the only treatment available was blood transfusion. Not all ESAs are approved for use in cancer patients in the United States, but they are prescribed with the goal of improving patients’ energy levels and quality of life. As a dangerous prescription drug attorney, however, I have been following this issue since 2007, when evidence emerged that ESAs may increase risks for cancer patients without increasing quality of life. That year, the FDA ordered “black box” warnings on this class of drugs, and Congress launched an investigation into off-label use and allegedly false quality-of-life claims.
This new order strengthens patient protections considerably. Doctors treating cancer of the lungs, head, neck, cervix and breasts will not only have to talk to patients about the risks, but document those talks. Every doctor who prescribes the drugs will have to join a safety register and complete education offered by drug makers Amgen and Johnson & Johnson. The manufacturers will also distribute a pamphlet on the risks.
As a defective medication lawyer, I am surprised only that this announcement took so long. Drug industry watchers have expected it since 2008. While I am pleased that the FDA’s action will do more to increase public awareness of the risks, I am concerned that it fails to address problems on several other fronts. This action affects only the risks suffered by cancer patients; patients taking ESAs for other problems must wait for an FDA ruling. But perhaps more importantly, the FDA’s action ignores clinical trials showing weak, if any, evidence that ESAs improve patients’ quality of life. If there is no benefit, why should patients assume the well-documented risks of taking ESAs? This is especially important considering their expense and the allegations of kickbacks raised in a 15-state lawsuit against manufacturers.


Carey, Danis & Lowe represents people from around the United States who have suffered serious illnesses, injuries or death because they took a faulty prescription drug. Our pharmaceutical liability attorneys help patients in this position, and their families, hold drug manufacturers legally responsible for the harm they do when they sell defective products or fail to warn patients about serious risks. Just as importantly for many families, we offer a way to recover the steep financial costs of treating a major health problem like a cancer reoccurrence or a heart attack. In a lawsuit, injured patients can request compensation for their illness, injury and personal losses, as well as all of their past and future medical costs and any lost income.
If you believe your family suffered a death or serious health problem because of a dangerous prescription drug, don’t hesitate to call Carey, Danis & Lowe. We offer free, confidential consultations, so you risk nothing by talking to us about your case and your rights. To set up a meeting, please call us toll-free at 1-877-678-3400 or contact us through the Internet.