Boston: The warning labels have been strengthened on three anemia drugs - Amgen's Aranesp and Epogen, and Johnson & Johnson’s Procrit, to alert the users about increased risk of heart attack, stroke, and even death.    

U.S. Food and Drug Administration noted the issue and made decision with drug manufactures about the risk of cancer growth. The anemia drugs are also known as erythropoiesis-stimulating agents or EPO drugs.

Numerous studies have revealed that risks of death in cancer patients with anemia may be due to overusing of the drugs and they increase tumor growth and decrease survival.  

The FDA said that it had approved revised boxed warnings and other labeling changes for Amgen’s Aranesp and Epogen and J & J’s Procrit due to the cases of increased risks of cancer and kidney failures in the patients.

The drug manufacturer, Amgen said six new clinical trials have been projected to assess the safety of such drugs when used to treat chemotherapy-induced anemia in particular tumor types.

The updated label for Aranesp includes instructions that therapy should be discontinued following the completion of a chemotherapy course, and lowest dose should be given to avoid a blood transfusion.
 
Hemoglobin levels should not be above 12 grams per deciliter of blood for patients with cancer. The risk of shortened survival and cancer progression is not less when the drugs are given to achieve hemoglobin of less than 12gms per deciliter.  

Aranesp is approved for the treatment related with chemotherapy and kidney disease. Epogen is given to treat anemia related with kidney disease. The two drugs generated 2006 sales of $4.1 billion in 2006 but those sales have been reducing because of safety concerns.

Amgen said, it had planned to submit new evidence to the Centers for Medicare and Medicaid Services in hope the agency would reverse its decision to pay for drugs in cancer patients undergoing chemotherapy when hemoglobin levels decrease below 10 grams.  

The warnings specify that ESAs should not be used by cancer patients unless the anemia was caused by chemotherapy, and once chemotherapy has finished they should stop taking ESAs.

To update patients on safety and effectiveness of ESAs, a new Medication Guide will also be issued.