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.

From philly.com:

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.