Thursday, June 07, 2007

Actos (Diabetes Drug) To Add Boxed Warning

Actos - the rival drug to Avandia - made by Takeda, will have added to its package insert a black box warning. The warning will increase awareness of risk of congestive heart failure. There are reports that the FDA asked to have the warning added. Source here.


An FDA commissioner told Congress on 6/6/07 hat the FDA was ordering GlaxoSmithKline and Takeda Pharmaceutical Co. Ltd. to add "black box" warnings to their diabetes drugs Avandia and Actos, strengthening existing warnings about heart failure, a condition where the heart does not adequately pump blood.

Congestive heart failure (CHF), or heart failure, is a condition in which the heart can't pump enough blood to the body's other organs. This can result from
  • narrowed arteries that supply blood to the heart muscle — coronary artery disease
  • past heart attack, or myocardial infarction, with scar tissue that interferes with the heart muscle's normal work
  • high blood pressure
  • heart valve disease due to past rheumatic fever or other causes
  • primary disease of the heart muscle itself, called cardiomyopathy.
  • heart defects present at birth — congenital heart defects.
  • infection of the heart valves and/or heart muscle itself — endocarditis and/or myocarditis

Source: Here.