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Type 2 Diabetes Drug Invokana Receives Second FDA Safety Warning of 2015

Filed October 28th, 2015 F.A. Kelley

An increased risk of bone fractures prompted the Food and Drug Administration (FDA) to issue a safety announcement to patients and health care providers about the type 2 diabetes drugs Invokana and Invokamet (canagliflozin), the second safety warning this year.

The FDA felt the safety announcement was necessary because bone fractures have been reported in patients taking canagliflozin and fractures have been seen as early as 12 weeks after the patient started using Invokana or Invokamet, according to the FDA. Canagliflozin has also been linked to decreases in bone mineral density in the hip and lower spine. 

The labels for Invokana and Invokamet already contain information about the fracture risk, but the FDA has now updated the Warnings and Precautions section in light of clinical trial results that confirm the increased risk of fractures. A clinical trial in elderly patients found that those who took canagliflozin for more than two years had reduced bone mineral density in their hips and lower spines. The FDA has added that information to the section on adverse reactions on the drug’s label.

The FDA advises physicians treating patients with type 2 diabetes to consider the individual patient’s fracture risk factors before prescribing Invokana or Invokamet. And patients should discuss any factors that might increase their risk for bone fractures. But the FDA reminds patients that it can be dangerous to stop or change any diabetes medicine without first discussing this with a doctor. Invokana and Invokamet help to control blood sugar in adults with type 2 diabetes. If blood sugar levels are not controlled, the patient can face serious health consequences, including heart disease, blindness, and nerve and kidney damage.

Invokana received FDA approval in 2013. It is the first drug in a new class of type 2 diabetes medications: sodium-glucose co-transporter 2 (SGLT-2) inhibitors. Invokamet received FDA approval in 2014, the FDA. Invokamet is a combination drug containing canagliflozin and metformin.

In May 2015, Invokana drew an FDA safety warning. The FDA warned that Invokana could cause ketoacidosis, a dangerous condition in which toxic acids accumulate in the blood. Ketoacidosis can be fatal if not treated, the FDA warns.

The FDA continues to evaluate the bone-fracture risk in Invokana, Invokamet, and other drugs in the SGLT-2 inhibitor class, including Farxiga and Xigduo (dapagliflozin), and Jardiance, Glyxambi, and Synjardy (empaglifozin). The agency wants to determine if additional label changes or studies are needed.



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