FDA Requires Safety Warnings On Two Anemia Drugs

Armen Hareyan's picture
Amgen Drug Warning from FDA

FDA has ordered two new safety warnings for two commonly used anemia drugs Procrit and Aranesp.

Procrit and Aranesp are erythropoiesis-stimulating agents (ESAs) both made by Amgen and are a part of cancer treatment. Chemotherapy is known to cause adverse side effects called anemia.

Two years ago there were several incidents occurring when use of these two drugs were associated with adverse side effects, such as heart attack, stroke, and and death. Since then Procrit and Aranesp were being investigated by FDA and this year finally the association decided to require safety warnings.


FDA requires that the drugs should not be prescribed to those patients who are expected to be cured. They can be prescribed only if patients can not receive transfusions of red blood cells. The drugs are not anymore allowed to be used for patients with high levels of hemoglobin - the levels must be below 10 grams per deciliter of blood.

An Amgen spokesman said, "This label is consistent with our expectations... We will soon be communicating the revised product labeling for ESAs to both physicians and patients. We are working with the agency to ensure that the medication's benefit outweighs the risk in this patient population."

Last year Congress decided that FDA can request safety warnings for drugs without negotiating with drug makers. This is the first time when FDA uses its authority to order such labeling and prescribing requirements.

Last year, in November, FDA "approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure."

The labeling changes, which incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007, also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs, states FDA press release from November 8, 2007.



The new label says that therapy shouldn't be initiated until red blood cell counts fall below 10 grams per deciliter of blood and it will no longer include an upper bound of 12 g/dl, which had been tantamount to declaring the drugs safe at that level for which, as the NYT's article points out, there is no evidence. It has been pointed out why did it take since March, when an advisory committee recommended the changes, for the FDA to act? Despite authority in the last year's FDA reform law to order changes without company negotiations, Amgen had been pushing to exclude certain restrictions from the label change, specifically, including a ban on using the drugs for breast or head and neck cancers, which the advisory committee had also recommended. The companies won that battle. But, the FDA left out the warning about tumor growth. For over a year now, regulators have been looking into suggestions that these drugs might fuel the growth of tumors. But much of that evidence comes from studies in which patients were treated more aggressively than the drugs' labels recommend. The FDA had said there was now "mounting evidence" of documented effects on tumor progression which require a reassessment of the net benefit of this class of drugs. Dr. Charles Bennett, a professor at Northwestion University, who authored the most recent analysis of anemia drug risks, said "It's clear that these drugs were overused because sales dropped so dramatically in the past years without seeing reports of people dying in the streets. At the 12th annual NCCN conference, an executive with United Health Group, pointed out that in reviewing records of patients who were prescribed the drugs, 44% of those patients had blood work-ups that would indicate they were not even anemic. Until this revelation, the drugs had a combined sales of over $6 billion a year. After this issue had started to be reported, U.S. Oncology took an 8-10 million dollar hit in its first-quarter SEC report last year, including reduced pre-tax income due to lower use of anemia drugs. The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for.