Skip to content
My WebMD Sign In, Sign Up

Diabetes Health Center

Font Size
A
A
A

Calm Urged for Avandia Patients

No Urgent Need to Stop Avandia, Some Experts Say; More Study Needed

Calls for Independent Look at Avandia Risk continued...

GSK's Krall says this is unnecessary as the FDA is already assembling an expert panel. He promises that GSK will make all of its data available to the FDA panel.

"We will try to share everything we have with the community of physicians," he says.

Nissen is skeptical.

"I have been discussing this with GSK, and they do not want to have a complete analysis done of all their data," he says. "If they are going to clear the air, now is the time. The reason they don't want to do it, I think, is they have already done it themselves and don't like the results."

Drexler says GSK's reassurances have so far been more of a public relations effort than a scientific effort. Krall bristles at that suggestion.

"There are a number of scientific manuscripts in preparation, that have been in preparation, that will help communicate to the scientific community the data that the FDA and European regulatory authorities already have seen," Krall says. "All of this is not under GSK control. Some of these studies have been done by external academic experts. It is they who are writing the actual manuscripts. There is an interest in this scientific data, and we are trying to respond as quickly as we can with scientific communications."

Avandia gained FDA approval in 1999. That approval was based on the drug's ability to lower diabetes patients' blood-sugar levels.

"Why do we control blood sugar in diabetes? The reason is to control complications of diabetes," Nissen says. "Avandia has never been shown to control any diabetes complication. They have had eight years to show a health-outcome benefit. Yet they've shown no reduction in microvascular [eye, kidney, and extremity] complications and no reduction in cardiovascular [heart] outcomes."

Krall says such studies began very soon after Avandia approval.

"It takes studies of 10 years' duration or more to show clinical endpoints," he says. "It took 10 years to see clinical results in studies of [the older diabetes drugs] metformin and sulfonylura. It is not fair to expect those results yet for Avandia. What is clear is that if you do manage [blood sugar levels], you do see those endpoints in 10-plus years' time."

Alternatives to Avandia

Another drug in the same class as Avandia, Actos, has already been shown to lower -- not raise -- the risk of heart disease in diabetes patients.

"It may be hard to justify continuing to prescribe Avandia if there is an alternative, Actos, that does not have same risk profile," Meneghini says. "So in terms of new Avandia prescriptions, I don't think so. It is not so much a clinical decision as a liability decision. Because if a patient says, 'I want to come off the drug,' and his doctors says, 'No, continue taking it,' and the patient has a heart attack -- for whatever reason -- well, you can imagine what comes after that."

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 and 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

Woman holding cake
Slideshow
feet
Slideshow
 
man organizing pills
Slideshow
Close up of eye
Slideshow
 

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
 

WebMD Special Sections