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Farxiga Approved By the FDA for Type II Diabetes

by Roni Shye on January 9, 2014 at 4:08 pm

Farxiga (dapagliflozin) was approved by the FDA for the treatment of type II diabetes this week, after a previous denial in January 2012 due to bladder cancer concerns. Here’s what you need to know:

How does Farxiga work, and are there any similar drugs available?

Dapagliflozin is part of a newer class of drugs: Sodium Glucose Co-Transporter 2 inhibitors (SGLT2 inhibitors). Invokana (canagliflozin), approved in March 2013, is the only other medication in this class.

SGLT2 inhibitors help remove excess sugar from the body via urination, which keeps it from being reabsorbed by your kidneys.

How is it usually taken?
Farxiga will be available as 5 mg and 10 mg tablets, taken once daily in the morning with or without food.

What are the common side effects?

Common side effects include fungal infections & urinary tract infections (UTIs).

What are the benefits?

Not only has dapagliflozin been shown to lower blood glucose levels but it can also help with weight loss, reducing A1C levels, and to lower blood pressure—all of which can be concerns for diabetics.

Should I be worried about the bladder cancer risk?

The current recommendation is that Farxiga shouldn’t be used by anyone who has active bladder cancer, and you should discuss with your doctor if you have a history of bladder cancer.

However, the FDA has granted the approval based on new information from the manufacturer and the recommendation of an FDA advisory panel that the benefits of dapagliflozin outweigh the risks. The FDA is also requiring post-market studies to continue assessing any risks associated with Farxiga.

Where can I find more information about Farxiga?
Check out this article from the FDA.
Check out the package insert here.

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