Avandia Gets New Black-Box Warning

'Strongest' FDA Label Warns Diabetes Drug May Up Heart Attack/Angina Risk

Nov. 14, 2007 -- The FDA has ruled that the diabetes drug Avandia must now carry a "black box" label warning that the drug may increase a person's risk of heart attack and angina.

The action follows the recommendation of the FDA's outside advisory panel. The panel last July voted 22-1 against removing the drug from the market, but said the drug's label should carry a stronger warning.

Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research, said the agency has now formally decided not to ban Avandia.

"We are keeping Avandia on the market because we have concluded there isn't enough evidence to determine that Avandia is more risky than other treatments for type 2 diabetes," Woodcock said at a news conference.

The FDA decision against an Avandia ban came after a split vote from its own internal safety review board.

While she declined to say how close the vote was, Woodcock said a majority of the safety board agreed to keep the drug on the market as long as its black-box label -- the FDA's strongest warning -- is updated.

In August, the FDA announced that all thiazolidinedione diabetes drugs -- the class of drugs including Avandia, Actos, Avandaryl, Avandamet, and Duetact -- would carry a black-box warning that the drugs may cause or worsen heart failure in some patients.

Avandia will now carry an additional black-box warning. The warning alerts patients and doctors to troubling but inconclusive evidence that the drug may increase a patient's risk of heart attack and angina (heart-related chest pain).

In addition, Woodcock said Avandia maker GlaxoSmithKline has agreed to fund a major clinical trial looking at whether Avandia carries a higher heart attack/angina risk than Actos.

Definitive results of that trial would not be available until 2014, although interim data analyses could possibly spot serious problems before then.

Avandia's new label also notes that the drug is not recommended -- but not contraindicated -- for patients already taking insulin or nitrate drugs. This means that doctors may still prescribe Avandia for such patients if they feel the benefit outweighs the risk.

"Avandia remains a safe and effective medicine for most patients with type 2 diabetes when used appropriately," GlaxoSmithKline Chief Medical Officer Ronald Krall, MD, says in a news release.

Answer:

Your level is currently NormalHigh (hyperglycemia).Low (hypoglycemia).

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.

Your blood sugar level is slightly high. You should call your health care provider and ask if laboratory tests to check for diabetes are needed. 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 currently normal. However, if you are concerned about diabetes speak with your physician. There may be other risk factors that increase your risk for diabetes.

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.

Your blood sugar level may be high, depending on when you last ate. If you have not eaten for at least 8 hours, your blood sugar should be less than 100. If you've eaten within the last 2 hours, your blood sugar should be less than 140. You should call your health care provider and ask if you need laboratory tests to check for diabetes. If you are pregnant always consult with your health care provider.

Blood sugars consistently above 180 warrant prompt medical attention.

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.

Your blood sugar level is high. You should call your health care provider and ask if laboratory tests to check for diabetes are needed. If you are pregnant always consult with your health care provider.

Today in Diabetes