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
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.
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.
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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.
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