FDA Warns of Increased Risk of Bone Fractures with Diabetes Medication Invokana

Concerned about an increased risk of bone fractures, the Food and Drug Administration (FDA) recently issued a safety announcement to patients and health care providers about the type 2 diabetes drugs Invokana and Invokamet (canagliflozin).

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

Invokana and Invokamet labels already contained information about the risk for bone fractures in the adverse reactions section. After recent clinical trials confirmed the increased risk of fractures, the FDA updated the information included in the Warnings and Precautions section of the label. 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 adverse reactions section of the drug’s label.

The FDA recommends that physicians treating patients with type 2 diabetes carefully consider the individual patient’s fracture risk factors prior to prescribing Invokana. And patients should be sure to discuss any factors that might increase their risk for bone fractures. But the FDA reminds patients that they should not stop or change any diabetes medicine without first discussing this with their doctor.

Invokana received FDA approval in 2013—the first drug in a new class of type 2 diabetes medications: sodium-glucose co-transporter 2 (SGLT-2) inhibitors. In 2014, the FDA approved Invokamet, a combination drug containing canagliflozin and metformin. These medications are used, in conjunction with diet and exercise, to help control blood sugar in adults with type 2 diabetes. Poorly controlled blood sugar can lead to a number of serious health consequences including blindness, nerve and kidney damage, and heart disease.

This is the second FDA safety warning for Invokana in 2015. In May, the FDA warned that Invokana could cause ketoacidosis, a dangerous accumulation of toxic acids in the blood. If not treated, ketoacidosis can be fatal, the FDA warns.

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

 

 

from Parker Waichman http://www.yourlawyer.com/blog/fda-warns-of-increased-risk-of-bone-fractures-with-diabetes-medication-invokana/