Japanese drug authorities have approved Forxiga (dapagliflozin) for the treatment of type 2 diabetes.
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, is a once-daily oral treatment that works independent of insulin to help remove excess glucose from the body. It is currently approved in more than 40 countries around the world, including the United States, where it is marketed under the brand name Farxiga.
SGLT-2 inhibitors are a relatively new class of diabetes medications. It was the first of its kind to be approved in Europe, and the second, behind Johnson & Johnson’s Invokana, in the United States. The class of drugs offers a new option for treating type 2 diabetes, a chronic disease related to obesity and sedentary lifestyles. Clinical trials on dapagliflozin suggests the drug can help patients lose weight.
Dapagliflozin side effects include fungal and urinary tract infections, and drug regulators have raised concerns whether the medication can also increase the risk of bladder cancer. Ten patients who used the medication during clinical trials developed bladder cancer. The drug’s approval in the U.S. hinges on the company’s willingness to collect long-term data on bladder cancer risk.
Cancer risks are a valid concern with type 2 diabetes medications. In 2011, studies revealed that Actos had been associated with an increased risk of bladder cancer. More recent studies suggest the diabetes drugs Januvia and Byetta are linked to a painful inflammation of the pancreas called acute pancreatitis as well as pancreatic cancer.