Skip to content

Diabetes Health Center

FDA Panel Splits Over Avandia Ban

20-12 Vote to Strengthen Avandia Warning, but Many Panelists Want Ban
Font Size
A
A
A
By
WebMD Health News
Reviewed by Laura J. Martin, MD

July 14, 2010 -- Avandia should carry more severe label warnings and perhaps require patient education, most members of an FDA advisory panel today voted.

However, 12 of the panel's 33 members advised the FDA to take the drug off the market. Several other panel members said they nearly voted the same way.

Only three panelists voted to leave Avandia on the market with its current label. Many panelists who voted not to ban Avandia said they did so because of worries that a small number of patients may need the drug if other treatments fail.

Ten of the panelists want Avandia maker GlaxoSmithKline to develop patient and doctor education programs to raise awareness of the drug’s risks. Avandia and Actos, the other approved drug in the same class, both increase risk of heart failure.

But there is growing but inconclusive evidence that Avandia also increases the risk of heart attack, fracture, infection, and high cholesterol.

"The evidence is much less convincing than we would like it to be … but there is meaningful evidence of Avandia harm, and I have not heard meaningful evidence of benefit that cannot be obtained by another drug. The public would be best served by not having the drug available," said panelist Richard Platt, MD, chair of population medicine at Harvard University.

"I absolutely could not vote for withdrawal," said panelist Arthur J. Moss, MD, professor of cardiology at the University of Rochester, N.Y. "I wanted to send a message to the FDA because a proper trial should have been done in 1993 when they first had an investigational new drug application [for Avandia], and that trial still needs to be done.

Critics: Avandia Clinical Trial Unethical

The split vote puts the decision on whether to ban Avandia back in the hands of the FDA. Although the FDA is likely to go with the panel vote, it may decide to ban the drug based on the reservations expressed by the majority of panelists.

The dramatic panel vote followed a discussion in which the 33 panel members agonized over their decision. They are fully aware that their deliberations will be a major factor in the way the FDA approves all new drugs in the future.

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!


or
Answer:
Low
0-69
Normal
70-130
High
131+

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.
 
Woman serving fast food from window
Video
Can Vinegar Treat Diabetes
Video
 
Middle aged person
Tool
are battery operated toothbrushes really better
Video
 

Prediabetes How to Prevent Type 2 Diabetes
Article
type 2 diabetes
Slideshow
 
food fitness planner
Tool
Are You at Risk for Dupuytrens Contracture
Article