In the final week of July 2017, the FDA issued a notification that it had approved a revised drug label for Invokana and Invokamet, as well as a revised Medication Guide for these two diabetes drugs from Janssen Pharmaceuticals.
From the most recent drug label, or Full Prescribing Information, for Invokana (accessed 7/27/17), here is the text of the so-called Black-Box Warning:
WARNING: LOWER LIMB AMPUTATION
• An approximately 2-fold increased risk of lower limb amputations associated with INVOKANA use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving INVOKANA for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur [see Warnings and Precautions (5.1)].
And from the Invokana Medication Guide revised in July 2017, in the “Amputations” section, we get this information directed to patients who are taking this drug, or Invokamet:
You may be at a higher risk of lower limb amputation if you:
o have a history of amputation
o have heart disease or are at risk for heart disease
o have had blocked or narrowed blood vessels, usually in your leg
o have damage to the nerves (neuropathy) in your leg
o have had diabetic foot ulcers or sores
We are currently investigating possible drug injury cases against the drug company, Janssen Pharmaceuticals, where a patient who used Invokana or Invokamet had to have a lower limb amputation. If you or someone in your family has had a toe, foot, or leg amputation, you can get Free Case Evaluation for such a case.
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