By Emily Miller
The U.S. Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar.
Farxiga is a once-a-day tablet designed to help diabetics eliminate excess sugar via their urine. That differs from older drugs that decrease the amount of sugar absorbed from food and stored in the liver.
The FDA reported that type 2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk of serious complications, including heart disease, blindness, nerve and kidney damage.
“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment options for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
The approval marks a milestone for the drug as it was rejected last year after studies raised concerns about links to bladder cancer and liver toxicity.
Ten cases of bladder cancer were found in patients taking the drug during clinical trials, so Farxiga warns patients with this disease to not take the drug. This is presented on Farxiga’s warning labels.
Last month a panel of FDA advisers stated that the uptick in cancers was likely a statistical fluke, and not related to the drug. But the FDA is advising patients with a history of bladder cancer to consult with their physician before using Farxiga.
The FDA is also requiring Bristol and AstraZeneca to track rates of bladder cancer in patients enrolled in a long-term follow-up study. In addition, the two companies will monitor rates of heart disease – a frequent safety issues with newer diabetes medications.
Other side effects associated with Farxiga include fungal and urinary tract infections. If you notice any side effects, please contact your physician immediately.
Farxiga was approved as a stand-alone drug, but could also be used in combination with other common diabetes treatments – such as insulin.
It is not uncommon for diabetics to use multiple drugs with different mechanism of action to help control their blood sugar levels. So consult with your physician to see if Farxiga is right for you and whether it is covered under your current health insurance policy.
