FDA Requires Safety Warnings On Two Anemia Drugs
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.