FDA adds two new warnings to diabetes drug Invokana

Invokana 149x210 FDA adds two new warnings to diabetes drug InvokanaThe Type 2 diabetes treatment Invokana hit the market in 2013 as the first drug in a new class of diabetes medications known as SGLT2 inhibitors. As with all new diabetes drugs, the Food and Drug Administration (FDA) ordered Johnson & Johnson’s unit Janssen Pharmaceuticals to collect data on heart risks. However, recent FDA alerts suggest that Invokana, and possibly other SGLT2 inhibitors, may carry other serious health risks.

Janssen is still collecting data on cardiovascular events in patients using Invokana. But last week, Eli Lilly and Co. announced that its SGLT2 inhibitor Jardiance cut death risk in diabetic patients at risk for heart attack and stroke. The news was encouraging for other drugs in the class, but the celebration was stunted for Invokana.

In May, the FDA issued a Drug Safety Communication warning that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood known as ketoacidosis. The agency had identified 20 cases of diabetic ketoacidosis (DKA) in patients treated with SGLT2 inhibitors from March 2013 to June 2014.

“All patients required emergency room visits or hospitalization to treat the ketoacidosis,” the agency said in a press release. “Since June 2014, we have continued to receive additional … reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.”

In September, the FDA singled Invokana out among all SGLT2 inhibitors in a warning for an increased risk of bone fractures and decreased bone mineral density, in particular at the hip and lower spine. The agency said it was reviewing similar risks with other SGLT2 inhibitors but only Invokana and Janssen’s similar drug Invokamet (a combination of Invokana and metformin) were ordered to update their labels to include warnings for osteoporosis risk including bone fractures and bone density loss.

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