Anemia Drugs Aranesp, Epogen & Procrit
Federal regulators have announced new warnings for anemia drugs following evidence that they can cause blood clots, worsen cancer, and increase the risk of death in some patients.
Aranesp, Epogen, and Procrit are in a class of drugs called erythropoiesis-stimulating agents (ESAs), primarily used to treat anemia in patients with chronic kidney failure (such as those with end-stage renal disease who require dialysis) and in patients with cancer whose anemia is caused by chemotherapy.
According to an FDA Public Health Advisory, reports of studies with ESAs have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents. FDA officials say Aranesp, Epogen, and Procrit will now carry "black-box" warnings (the most serious kind) on the labels of the anemia drugs to warn about the newly identified risks, including: “Increased Mortality, Serious Cardiovascular and Thromboembolic Events”. The agency is currently re-evaluating the safe use of this drug class.
On March 21, 2007, The House Committee on Energy and Commerce sent letters to drug makers Amgen (Epogen and Aranesp) and Johnson & Johnson (Procrit), asking them to clarify when they knew about the possible risks associated with the drugs and how they have promoted the drug. In these letters, committee members said they viewed reports of safety issues associated with the drugs "with increasing alarm." They also noted reports that as much as $700 million in annual sales of the three drugs were for uses that did not conform to the label.
As the fifth-leading class of prescription pharmaceuticals sold in the US, these drugs are overtly advertised directly to consumers, even though they are extremely expensive and only available by injection. Many believe these advertisements have contributed to over-prescribing by doctors, for uses which are often not FDA-approved.
If you or a loved one have been prescribed Aranesp, Epogen or Procrit, please contact our attorneys immediately.
FDA Public Health Advisory: March 9, 2007
Patients currently using or considering the use of an ESA (erythropoiesis-stimulating agents) should know the following:
- A higher chance of death and an increased rate of tumor growth were reported in patients with advanced head and neck cancer receiving radiation therapy and in patients with metastatic breast cancer receiving chemotherapy, when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
- A higher chance of death was reported and no fewer blood transfusions were received when ESAs were given to patients with cancer and anemia not receiving chemotherapy.
- A higher chance of death was reported and an increased number of blood clots, strokes, heart failure, and heart attacks was reported in patients with chronic kidney failure when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
- A higher chance of blood clots was reported in patients who were scheduled for major surgery and given ESAs.
- ESAs are not approved for treatment of the symptoms of anemia, such as fatigue in patients with cancer, surgical patients and patients with HIV.
Important study results include the following:
- Patients with chronic kidney failure had an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain higher red blood cell levels (hemoglobin more than 12 g/dL).
- Patients with head and neck cancer receiving radiation therapy had faster tumor growth when ESAs were adjusted to maintain hemoglobin levels higher than 12 g/dL.
- Patients with cancer not receiving chemotherapy died sooner and had no fewer blood transfusions when ESAs were given according to the dosing recommendations for cancer patients receiving chemotherapy.
- Patients scheduled for orthopedic surgery who received ESAs to reduce blood transfusions during and after surgery had more blood clots than those not given an ESA.
