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FDA Strengthens Warnings About Invokana Side Effects

FDA Warns Invokana Can Cause Bone Fractures in New Warning Label

Invokana Bone FracturesInvokana is the brand name Type 2 diabetes treatment manufactured in the U.S. by Janssen / Johnson & Johnson, and now has a stronger warning after a more in-depth FDA investigation.

The stronger warning was issued after a new trial involving 714 elderly patients taking the diabetes medication showed a significant amount of bone density loss – a problem people already face as they age. The bone loss was focused especially around the hip and lower spine area, and began as soon as 12 weeks (just 3 months) after patients began taking the drug. The bone loss led to an increased risk of bone fractures, an especially dangerous issue in patients who may already suffer a fall risk.

The “adverse reactions” section on Invokana’s label already features a warning about potential bone fractures, but the FDA has strengthened that warning after the latest investigation showed how serious the bone loss could be.

Invokana was approved as a Type 2 diabetes treatment in 2013, with a similar drug, Invokamet, receiving approval just a few months later. The drugs are in a class called SGLT2 inhibitors. The FDA approved Invokana to treat diabetes despite warnings from medical professionals regarding the serious risks to patients who lose bone density, especially when that bone loss involves vertebrae or the hip.

“Although canagliflozin causes a small increase in mean PTH concentration (7.9%), the standard deviation is large. Thus, a substantial number of patients treated with canagliflozin might have a 50% or greater increase in PTH concentrations — a change that could be clinically significant,” the study authors wrote. Canagliflozin is the generic form of Invokana.

The FDA also issued a statement saying that J&J must complete a study in the next 2 years to further examine how bad the bone loss and bone fractures can be.

There has not been a drug recall for Invokana yet, but several patients and their families have filed personal injury lawsuits because of the treatment. Many of the lawsuits involve kidney failure and ketoacidosis, not bone loss.  The problem could become such a great issue as more and more patients receive Invokana prescriptions that a separate class action could be filed just due to severe bone fractures and bone loss. Other severe side effects involving Invokana patients include a greater risk of heart attack and stroke.  However, because Type 2 diabetes increases a patient’s risk of heart attacks and strokes anyway, it is difficult to tell if Invokana can be linked to this problem specifically.

“The additional data confirm the finding that fractures occur more frequently with canagliflozin than placebo, which is an inactive treatment,” the new FDA warning states. “Fractures can occur as early as 12 weeks after starting the drug. In the clinical trials, when trauma occurred prior to a fracture, it was usually minor, such as falling from no more than standing height.”

The FDA added in a statement: “We are continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapaglifozin (Farxia, Xigduo XR) and empagliflozin (Jardiance, Glyxambi, Synjardy) to determine if additional label changes or studies are needed.”



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