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FDA Warns Invokana May Increase Bone Fracture Risk


The FDA strengthened the warning for type 2 diabetes drug, canagliflozin (Invokana, Invokamet), to note that the drugs may increase the risk of bone fracture and decrease bone mineral density.

In a drug safety communication, posted last week, the FDA said they have added a new warning and precaution and have revised the adverse reactions section of the drug labels to reflect this fact.

Last year, a researcher wrote in Lancet Diabetes & Endocrinology that there is a possible relationship between the drug, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, and bone fractures, especially for postmenopausal women. She cited numerous studies showing a possible link as evidence.

The FDA said that healthcare professionals should consider factors that may contribute to fracture risk before starting their patients on canagliflozin. The agency also noted the following information:

  • Bone fractures have been seen in patients on canagliflozin
  • Fractures can occur as early as 12 weeks after starting the drug
  • In addition to bone fractures, canagliflozin has also been linked to decreases in bone mineral density at the hip and lumbar spine

Other side effects of canagliflozin may include dehydration, kidney problems, low blood sugar (when used with other diabetes medications), high potassium levels in the blood, increased cholesterol, and yeast infections. The FDA asked that healthcare professionals and patients are encouraged to report adverse events related to this drug to their MedWatch Safety Information and Adverse Event Reporting Program.

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