Editor's note: On Jan. 19, 2012, the pharmaceutical companies AstraZeneca and Bristol-Myers Squibb announced that the FDA rejected their approval request for dapagliflozin, calling for more research data on the drug’s benefits and risks. Both companies say they remain committed to developing the drug and will work with the FDA to determine the next steps.
July 19, 2011 -- In a 9-6 vote, an advisory panel said the FDA should not yet approve dapagliflozin, a new type of diabetes drug that makes the body dump sugar and lose weight.
Signals of possible liver damage and of breast and bladder cancer worried the experts.
The split vote, as well as panelist comments, makes it uncertain whether the FDA will approve the drug, jointly made by Bristol-Myers Squibb and AstraZeneca. The FDA will certainly ask the companies to gather more data on side effects; the key question is whether the agency will ask for this data before or after approval.
Dapagliflozin is the first in a new class of diabetes drugs. Normally, the kidney recycles sugar back into the body. But dapagliflozin inhibits a transporter molecule called SGLT-2. The result: Sugar passes out of the body in the urine, lowering blood sugar without affecting insulin levels.
Another result: Patients lose weight. In clinical trials, type 2 diabetes patients who took dapagliflozin for six months lost 1 to 5 pounds. In a special study to look at weight loss in people with diabetes, 30% of those who took dapagliflozin plus metformin lost 5% of their body weight.
A downside to the drug is that diabetes often damages the kidneys. Even moderate loss of kidney function makes dapagliflozin much less effective. The drug would be given only to patients with sufficient kidney function, but some panelists questioned the value of a proposed test to determine which patients could take dapagliflozin.
And the drug has side effects. All that sugar in the urine increases patients' risk of urinary tract and genital infections. There are other worries, too -- including dehydration and heat intolerance -- but members of the advisory committee were far less worried about these side effects than about the possible risk of cancer and liver toxicity.
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.
Thank you for signing up for the WebMD Diabetes Newsletter!
You'll find tips and tricks as well as the latest news and research on Diabetes.
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.