FDA plan requires Amgen, J&J to educate doctors and patients on risks of anemia drugs
By APTuesday, February 16, 2010
FDA asks Amgen, J&J to discuss anemia drug risks
RISK PLAN: Under a plan reached with the Food and Drug Administration, Amgen and Johnson & Johnson are required to document that cancer patients are briefed on the risks of anemia drugs before receiving them.
BIG SELLERS: The three medicines at issue are multibillion dollar sellers because of their ability to boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions.
HISTORY OF PROBLEMS: Sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth. The new risk plan was developed with the FDA following a 2008 meeting.
LOWER SALES: Combined sales of Epogen, Aranesp and Procrit fell nearly 30 percent between 2006 and 2008, according to health care data firm IMS Health.
Tags: Anemia, Diagnosis And Treatment, Diseases And Conditions, Geography, Medication, North America, United States, Washington
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