WASHINGTON The Food and Drug Administration is questioning the evidence used to support an anemia drug made by Amgen and Johnson & Johnson. Anemia is a deficiency of red blood cells.
The FDA has said it found "important deficiencies" in material that is being used to prove the drugs improve quality of life for anemic kidney disease patients by boosting their energy. The names of the drugs are Epogen and Aranesp, manufactured by Amgen and Procrit by Johnson and Johnson.
The agency is also questioning the proper dosage for the drugs when given to patients who are suffering from kidney failure. High doses of the drugs have been linked to cardiovascular and cancer-related risks.
Medicare will be watching this outcome closely as they have also expressed concerns regarding dosages and are stating that they will limit coverage depending on dosage requirements.