Diabetes drug Farxiga label updated to include new warnings for bladder cancer risk

actos pioglitazone hydrochloride Diabetes drug Farxiga label updated to include new warnings for bladder cancer riskThe safety labels of the new type 2 diabetes drug Farxiga (dapagliflozin) have been updated to advise patients and health care professionals not to monitor glycemic control with urine glucose tests in patients taking Farxiga or similar drugs in the class because the drugs increase urinary glucose excretion and will lead to positive glucose tests. Alternative methods are advised to monitor glucose control.

Farxiga was approved by the Food and Drug Administration (FDA) in January to help lower blood sugar levels in patients with type 2 diabetes. Manufactured by AstraZeneca and Bristol-Myers Squibb, Farxiga had been previously rejected because of bladder cancer, heart disease and liver toxicity concerns.

The most common side effects with Farxiga include fungal and urinary tract infections; however, 10 cases of bladder cancer have been found in patients who used the drug in clinical trials. As a result, the drug’s makers are required by the FDA to monitor bladder cancer rates in patients who used the medication. A warning was also placed on the drug’s label. The drug companies are also required to keep record of cardiovascular risks.

The bladder cancer warning is especially worrisome. Not only are patients with type 2 diabetes at greater risk for developing bladder cancer, some medications can increase the risk for the disease. In 2011, the FDA warned that studies had linked Actos to an increased risk of bladder cancer.

Takeda, maker of Actos, is currently embroiled in lawsuits that number in the thousands. The cases allege the company tried to cover up the risks of bladder cancer associated with the drug in order to reap greater profits.

Source: FDA