Stronger warnings regarding bone fracture risk in people taking the type 2 diabetes treatments Invokana and Invokamet will be added to the drugs’ safety labels following an evaluation by the Food and Drug Administration (FDA).
A new warning will be added to the WARNINGS AND PRECAUTIONS section and the listing under ADVERSE REACTIONS will be revised to reflect this increased risk in particular with individuals who have decreased bone mineral density.
Invokana and Invokamet, which contain the active drug ingredient canaliflozin, were approved by the FDA in 2013 and 2014, respectively. The drugs are in a new class of type 2 diabetes treatments known as SGLT2 inhibitors. Other drugs in this class include the brand names Farxiga, Xigduo XR, Jardiance, Glyxambi, and Synjardy. The FDA says it will continue to evaluate bone fracture risk in these other SGLT2 inhibitors to determine if further label changes are warranted.
Fractures in patients taking Invokana or Invokamet can occur as early as 12 weeks after staring the medication. The medication has also been linked to decreases in bone mineral density at the hip and lower spine.
Before prescribing Invokana or Invokamet, doctors are advised to consider factors that contribute to a patient’s fracture risk, such as low bone mineral density, which indicates a patient has weaker bones.
Any side effects, such as decreases in bone mineral density or bone fractures, in patients taking these drugs should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.