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FDA Updates Warning About Invokana Bone Risks

InvokanaThe FDA has strengthened warnings that diabetes drug Invokana is related to an increased risk of bone fractures and a significantly greater loss of bone density than a placebo.

The move comes as a result of the findings of clinical trials involving Invokana (canagliflozin) and 714 elderly subjects with Type 2 diabetes.

The subjects displayed greater bone density loss near the hip and lower spine areas than those subjects who used a placebo. The fractures occurred as early as 12 weeks after a patient began using the drug.

Johnson & Johnson has had high hopes for Invokana, approved by the FDA in 2013, to be their newest blockbuster drug after achieving sales of $596 million in the first six months of 2015. In the twelve month period from July 2014 to June 2015, 1.1 million patients were prescribed Invokana to battle their type 2 diabetes.

Johnson & Johnson fears losing market share

However, with this new FDA directive, Johnson & Johnson now fears that the strengthened warnings about fractures and bone density loss will set them back in the race to market share against Lilly and Boehringer Inglehiem’s SGLT2 inhibitor entry, Jardiance, into the Type 2 diabetes competition. Jardiance (empagliflozin) also sought to pull away from Invokana with last month’s announcement that it is now the first diabetes drug to lower the risk of heart attack, stroke, and cardiovascular disease.

Canagliflozin is a prescription medicine belonging to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It is intended to lower blood sugar in adults with type 2 diabetes when combined with a sound diet and an exercise regimen. Both Invokana and Invokamet cause the kidneys to remove sugar from the blood through the urine.

Invokana side effects

Aside from a propensity to bone fractures and decreased bone density, users have reported other adverse side effects of Invokana and other SGLT2 inhibitors. Ketoacidosis, yeast infections, increased cholesterol counts, kidney problems, dehydration, higher than normal potassium levels, and low blood sugar when combined with other diabetes medicines have been noted.

Regarding the increased risk of bone fractures and decreased bone density from the use of canagliflozin, the FDA said, “We added a new Warning and Precaution [based on additional data that fractures occur more frequently with canagliflozin than a placebo] and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.” The FDA advises all Invokana and Invokamet users to “talk to their health care professionals about factors that may increase their risk for bone fracture. Patients should not stop or change their diabetes medicines without first talking to their health care professional.”

The FDA also added new safety information to the Adverse Reactions section of the Invokana label as a result of the findings of the 714-patient clinical trial which showed “a greater loss of bone mineral density at the hip and lower spine than a placebo.”

The FDA is asking both health care professionals and patients to report side effects from canagliflozin or other SGLT2 inhibitors to the FDA MedWatch program.

“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,” said health regulators at the FDA.

  1. FDA, Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density 

  2. Institute for Safe Medication Practices, Adverse Event Signals for Canagliflozin