Avandia Gets Black Box Warning Label
The Food and Drug Administration (FDA) has announced that the makers of Avandia and Actos have agreed to black box warning labels, the strongest label a prescription drug can receive in the United States. The new labels will alert consumers and healthcare professionals of the serious risk of heart failure posed by both diabetes drugs.
Avandia has been under fire from researchers and members of the FDA for its connection to heart failure and heart attack. Both Avandia and Actos are approved to help people with Type 2 diabetes control their blood sugar levels.
The updated warning labels will only reflect the connection between the diabetes drugs and heart failure. Heart attack was not placed on the black box warnings, although it has been identified a as potential risk of taking Avandia and Actos.
"Avandia Actos to include 'black box' warnings." The Associated Press. August 14, 2007.
"Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk." FDA Press Release. August 14, 2007.