Skip to content

Diabetes Health Center

Font Size

Stronger Warning for Actos, Avandia

Previous Heart Warnings for 2 Diabetes Drugs Elevated to ‘Black Box’ Status
WebMD Health News
Reviewed by Louise Chang, MD

June 6, 2007 -- The diabetes drugs Actos and Avandia will soon carry a "black box" warning that the drug may trigger heart failure.

The surprise announcement came in statements made by FDA commissioner Andrew C. Von Eschenbach, MD, before a U.S. House committee investigating whether the FDA failed to heed warnings of possible heart attack risks posed by Avandia.

The new black box warnings have nothing to do with heart attacks. The label will warn that the class of drugs to which both Actos and Avandia belong increase a person’s risk of congestive heart failure. The drugs current labels warn of this risk, but the new warning will be far more prominent.

The two drugs increase the body's tendency to accumulate fluids due to inadequate pumping from the heart -- a complication of diabetes. This can trigger heart failure.

A heart attack is a different issue. Heart attacks occur when something blocks blood flow to the heart, causing heart tissue to die.

The recent firestorm over Avandia concerns evidence suggesting - but by no means proving -- that Avandia may increase the already high risk of heart attacks in people with diabetes. GlaxoSmithKline points to studies that show no clear increased risk of heart attack in patients taking Avandia. However, editorials in this week's issue of The New England Journal of Medicine warn that the jury is still out and that Avandia may pose a heart attack danger.

In testimony before the House committee, GSK research and development chair Moncef Slaoui, PhD, defended Avandia's heart safety.

"Avandia, when compared to other widely used antidiabetes medicines, is not associated with an increased risk of death, including death from a cardiovascular event," Slaoui said in a prepared statement.

Actos has not been linked to any increased risk of heart attack.

"Takeda remains confident in the safety and efficacy of Actos when used according to its label, and with this revision, we can heighten patient and physician awareness of an already known but serious side effect," Takeda senior medical director Robert Spanheimer, MD, says in a news release.

Is This Normal? Get the Facts Fast!

Check Your Blood Sugar Level Now
What type of diabetes do you have?
Your gender:

Get the latest Diabetes newsletter delivered to your inbox!


Your level is currently

If the level is below 70 or you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

Did You Know Your Lifestyle Choices
Affect Your Blood Sugar?

Use the Blood Glucose Tracker to monitor
how well you manage your blood sugar over time.

Get Started

This tool is not intended for women who are pregnant.

Start Over

Step:  of 

Today on WebMD

Diabetic tools
Symptoms, diagnosis, treatment, and more.
woman flexing muscles
10 strength training exercises.
Blood sugar test
12 practical tips.
Tom Hanks
Stars living with type 1 or type 2.
kenneth fujioka, md
Can Vinegar Treat Diabetes
Middle aged person
Home Healthcare

Prediabetes How to Prevent Type 2 Diabetes
type 2 diabetes
food fitness planner