On Sept. 10, the U.S. Food and Drug Administration (FDA) strengthened the warning for the type-2 diabetes medication canagliflozin (Invokana, Invokamet) due to the increased risk of bone fractures, and provided new information about decreased bone mineral density.

What is Invokana?

Invokana (canagliflozin) is a prescription medication designed to be used in combination with diet and exercise to lower blood sugar in adults with type-2 diabetes. It belongs to a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Canagliflozin is available as a single-ingredient product under the brand name Invokana and also available in combination with the diabetes medicationmetformin under the brand name Invokamet.

Diabetes Medication – The First FDA Warning

In May 2015, the first FDA warning on Invokana was issued. At that time, the FDA had determined the SGLT2 inhibitors in the drug were causing ketoacidosis, a condition where high blood acid levels can result in some serious health conditions.

The symptoms of ketoacidosis include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue.  If left untreated, these symptoms can spiral into a greater more permanent health problem- even resulting in death.

FDA Now Warns of Bone Fracture

Now, an entirely different side effect has been associated with the diabetes medication; mass reports of bone fracture were recorded after as little as 12 weeks of taking the drug. This new warning from the FDA states that patients taking Invokana face a risk of bone fracture and decreased bone mineral density.

Since its release in the U.S. in May 2013, the FDA has been investigating Invokana for bone safety and risk of bone fracture as it showed some early concerns.

Although information concerning fractures was originally in the Adverse Reactions section of the drug label at the time of the drug’s approval, recent information gained from several clinical trials, necessitated the updated warning.

The updated data confirmed the findings that bone fractures occur more frequently with canagliflozin than with a placebo. In the clinical trials, when the trauma did occur prior to a fracture, it was usually minor, such as falling from no more than standing height.

The FDA also added new information regarding the risk of decreased bone mineral density at the hip and lower spine to the canagliflozin label. A clinical trial was conducted and showed changes to bone mineral density over two years in 714 elderly individuals.

The clinical trial also revealed canagliflozin caused greater loss of bone mineral density at the hip and lower spine than a placebo.

Healthcare professionals are advised to consider factors that contribute to fracture risk before starting patients on canagliflozin, and to counsel patients about factors that might contribute to bone fracture risk.

Additionally, the FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed.

Diabetes Medication Lawsuits

Currently, attorneys are investigating the possibility of filing diabetes medication lawsuits against several pharmaceutical manufacturers, claiming that the drug makers knew or should have known of the high risk of diabetic ketoacidosis and bone fractures associated with their diabetes medications, but failed to provide adequate warning in an effort to protect company profits.

If you or a loved one suffered serious Invokana side effects or side effects from Farxiga, Jardiance or another SGLT2 inhibitor drug, you may be owed substantial compensation for medical expenses and other damages.

In general, diabetes medication lawsuits are filed individually by each plaintiff and are not class actions.