The FDA has approved dapaglifozin (Farxiga) to treat adults with type 2 diabetes, the agency said Wednesday in a news release.
The drug, to be used for blood sugar control along with proper diet and exercise, is designed to prevent re-absorption of glucose by the kidneys. Dapaglifozin’s safety and effectiveness were established in clinical trials involving more than 9,400 patients with type 2 diabetes. The most common side effects were fungal infections and urinary tract infections. More serious adverse reactions included dehydration, hypotension, and fainting.
Bladder cancer developed in an abnormally high number of clinical trial participants who used dapaglifozin, so the drug is not recommended for patients with active bladder cancer. Patients with a history of the disease should consult a physician before using the drug, the FDA said.
The agency said it is requiring six post-marketing studies to further evaluate issues such as risk for cardiovascular disease, bladder cancer risk, use among children and pregnant women, and effects on the liver.
The drug is marketed by Princeton, N.J.-based Bristol-Myers Squibb and Wilmington, Del.-based AstraZeneca.