FDA Issues Warning About Type 2 Diabetes Drug Invokana

The FDA has issued a Drug Safety Communication about a type-2 diabetes drug, canagliflozin, marketed under the names Invokana and Invokamet, to warn about a possible decrease in bone density and the increased risk of bone fracture with use.

The FDA strengthened its Warning and Precaution labeling on the type 2 diabetes drug and also made labeling changes to warn of decreased bone density especially in the hip and lumbar spine, bone fractures from minor incidents that can occur as early as 12 weeks after starting the drug and increased risk of bone fracture to post-menopausal women.

Other side effects with use include:

  • Dehydration
  • Kidney problems
  • Low blood sugar if used in conjunction with other type-2 diabetes medications
  • Elevated potassium levels in the blood
  • Increased cholesterol
  • Yeast infections

The FDA warns healthcare providers to consider all risk factors of individual patients before prescribing the diabetes drug and advises patients to communicate any risk factors to their prescribing healthcare provider. The FDA also cautions patients currently taking the drug not to stop taking it until speaking with their healthcare provider who should warn patients of all potential risks before prescribing the drug so patients can make an informed decision.

In order to continue to monitor the risk factors and adverse effects of the drug, the FDA asks all doctors and patients to report any adverse events by completing an Adverse Event Report online at http://www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a copy of the form.