A new drug has been approved by the Food and Drug Administration (FDA) to help regulate blood sugar in patients with type 2 diabetes. Farxiga, developed by AstraZeneca and Bristol-Myers Squibb, has been available in Europe under the name Forxiga. U.S. drug regulators rejected the drug last year because of bladder cancer, heart disease and liver toxicity concerns.
Farxiga is the second in a class of drugs known as SGLT2 inhibitors to be approved in the United States. Johnson & Johnson’s Invokana was approved earlier this year. Other drugmakers, including Boehringer Ingelheim, are also developing SGLT2 inhibitors. Drugs in this class have been associated with weight loss. Obesity is linked to the development of type 2 diabetes.
Most common side effects with Farxigna include fungal and urinary tract infections. However, more serious health concerns have been noted. Ten cases of bladder cancer were found in patients using Farxiga in clinical trials, which FDA advisors said was likely a statistical fluke.
Even so, the drug’s makers are required to track rates of bladder cancer in patients enrolled in a long-term follow up study. A warning is also placed on the drug’s label. The drug companies are also required to monitor rates of cardiovascular events.
Heart disease and cancer risks are common safety issues with newer diabetes medications. In 2010, the FDA severely restricted the use of Avandia after the drug was linked to fatal heart attacks. The agency lifted many of those restrictions last year even though there was still “uncertainty” about its cardiovascular risks.
In 2011, the FDA warned that studies had linked Actos to bladder cancer. And, last year, studies showed that the type 2 diabetes drugs Byetta and Januvia had been linked to pancreas inflammation leading to acute pancreatitis and pancreatic cancer.