Diabetes Self-Management Blog

On January 8, the US Food and Drug Administration (FDA) approved the oral Type 2 diabetes medicine Farxiga (generic name dapagliflozin), a joint development of Bristol-Myers Squibb and AstraZeneca. Farxiga will join Invokana (canagliflozin) as a member of the class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.

In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Farxiga blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.

The medicine, which is already available in Europe under the brand name Forxiga, was initially denied approval in 2012 over a lack of information about its risks and benefits. In mid-December of 2013, an FDA advisory panel voted 13 to 1 in favor of approving the medicine, and 10 to 4 that it had an acceptable cardiovascular risk level.

Farxiga tablets are approved for use in conjunction with diet and exercise in adults with Type 2 diabetes alone or in combination with metformin, Actos (pioglitazone), Amaryl (glimepiride), Januvia (sitagliptin), and insulin.

The medicine comes in tablet strengths of 5 milligrams and 10 milligrams. The recommended starting dose is 5 milligrams once daily, taken in the morning with or without food. In certain people requiring increased blood glucose control, the dose can be increased to up to 10 milligrams daily.

The safety and effectiveness of Farxiga were established through 16 clinical trials, involving more than 9,400 people with Type 2 diabetes, that showed improvements in A1C levels (a measure of blood glucose control over the previous 2–3 months).

This medicine should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body). It should also not be used in people who have kidney problems.

Because an increased number of bladder cancers were diagnosed in people using Farxiga in clinical trials, it is also not recommended for those who have active bladder cancer. People with a history of bladder cancer should talk to their health-care providers before using the medicine.

The FDA is requiring six trials of Farxiga once it is on the market, including one focusing on cardiovascular events; an “enhanced pharmacovigilance program” to monitor liver abnormalities and adverse pregnancy outcomes; two studies looking at how the drug works and how safe and effective it is in children; an assessment of bladder cancer risk; and a study looking at the medicine’s effects on bladder tumors in rodents.

Because of its diuretic effect, Farxiga may cause postural hypotension, or sudden low blood pressure upon standing; this can cause symptoms such as dizziness or fainting. The most common side effects of Farxiga are genital fungal infections and urinary tract infections.

For more information, see the press release on the FDA’s Web site.

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Comments
  1. Diane: Thank you for informing us of this new interesting drugs. Dr. Parker’s web site also had data and info.

    Now we have a drug that can help throw excess glucose over the side. In combination with metformin provide a one - two - punch to excess glucose in the blood.

    Most amazing new data and an intriguing drug!

    Posted by jim snell |
  2. Would this or has this also been shown to lower weight? If excess sugar is eliminated I would think weight loss would follow.

    Posted by SweetGuy |
  3. The side effects make me question whether I would want to take a chance on it. Diabetics already have medical problems just by having the disease. I would also want to know the cost because so many new drugs are so expensive and drug insurance companies won’t pay for them.

    Posted by Ferne |
  4. I know new drugs to treat all diseases are important, but I just wish there was more emphasis on diet & exercise to treat diseases like type 2 diabetes. This is a disease that CAN be treated successfully with drastic changes in lifestyle. Little changes are always emphasised because they’re easier to do. But if people with type 2 REALLY want to improve their lives, they need to get on board with bigger changes! Don’t just change from white bread to whole wheat, try getting by with higher amounts of fruits & vegetables instead. I did that, lost over 20 lbs, exercise 6 days a week and have gone off Glyburide and also have brought my A1c down to 5.7. It’s never too late…I turn 70 in a couple of months.

    Posted by Pam |
  5. what type of genital infections are associated with this?then there is the uti’s which a lot of people have serious concerns off.i would like more information, before deciding on trying it.

    Posted by bennie trevino |
  6. Since I cannot have certain drugs, I need to know if this has anything with sulfites, sulfur, sulfa in it.
    I am interested since stress has me in another world lately with Mom and her dementia. Then I got injured which both raise glucose and my A1C rose.

    Posted by Daizie |
  7. My diabetic specialist just ordered some for me but I am on Medicare disability and Medicare will not cover this drug!!!!!!!!!!!!

    Posted by Phyllis |
  8. I have to disagree with Pam’s all assertion that diet and exercise can fix all cases.

    For those with no medical complications such comments are not reasonable nor acceptable.

    I do agree that there are three aspects so far that in some of the worst cases require diet, exercise and meds.

    I faced that and did extensive diet and exercise that today while still critical, closing the loop required careful and timely use of metformin to yank back the liver’s excess glucose release uneeded.

    I worked the extensive diet 2 years and the mess did not stop till targeted meds finished the job.

    I agree that diet and exercise can haul back dietary sources of excess glucose but when other organs defeat that, additional help may be needed.

    I wish folks would not hop on this with their own schmoo diagram experiences and somehow believe that is all one needs to do for everybody!

    Posted by jim snell |
  9. Thank you for those comments, Jim

    Posted by Ferne |
  10. Ditto Jim Snell. I get sick of hearing this too. Also, to Bennie Trevino, she stated the genital infections are fungal.

    Posted by Valerie |
  11. The extra glucose in the exhausted urine apparently does help feed the yeast and fungus ( candida albacans et all) from using this drug. From Dr. Parker’s Diabetic Mediterranean Diet web site.

    Posted by jim snell |
  12. I have diabetes type 2 and I’m not overweight. I’m 80 years old, 5 ft 1/2 inch tall and weigh 116 this morning. My doctor put me on glipizide a couple of years ago and all of a sudden in the last week or two, my A1C has jumped; this morning I recorded a 275. I only had a banana yesterday with pancakes (which never made it jump before), homemade soup for lunch, pork chop for dinner with a half of a small potato and carrots for veggie. I don’t know what the heck I’m doing wrong; all of a sudden the numbers are high and I don’t like it. What can I do?

    Posted by Kallie |
  13. Basically, this drug is the same as Invokana, which is already available with a prescription. It helped me lose weight but did not lower my blood sugar reading because my doctor cut my amaryl in half.

    Posted by Ira |

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