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Sheller, P.C.
Sheller, P.C.
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FDA Updates Invokana Label, Includes Stronger Warnings

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The U.S. Food and Drug Administration (FDA) has strengthened the warning for the Type II diabetes drug canagliflozin (Invokana, Invokamet) to include the increased risk of bone fractures and added new information about decreased bone mineral density.

In 2013, Invokana became the first sodium-glucose co-transporter 2 (SGLT2) inhibitor approved by the FDA.  A year later, the FDA approved Invokamet, which is a combination of canagliflozin and metformin.  Doctors prescribe these medications in addition to diet and exercise to reduce blood sugar levels in adults with Type II  diabetes.

The labels for Invokana and Invokamet included information about the risk for bone fractures in the adverse reactions section.  However, after recent clinical trials confirmed evidence that the drugs increased the risk of bone fracture, the FDA updated the information under the Warnings and Precautions section of the label.  The drug label’s Warnings and Precautions section now reflects clinical data showing that fractures occur at a higher rate with canagliflozin then without treatment.  Fractures can occur as soon as 12 weeks after starting the drug.

A separate clinical trial also found that elderly patients taking canagliflozin for more than two years suffered losses in bone mineral density in their hips and lower spines. The FDA added this new safety information to the adverse reactions section of the drug’s label.

The new and strengthened warnings are in addition to an FDA warning in May in which the agency said Invokana could cause ketoacidosis. Ketoacidosis is a condition where dangerous levels of toxic acids accumulate in the blood. It can be fatal if is not treated.

The FDA is still continuing to monitor whether the same risks apply to other drugs in the SLGT2 inhibitor class like dapagliflozin (Farxiga), empagliflozin (Jardiance) and linagliptin (Glyxambia) to determine if additional label changes and studies are needed.