The FDA has added a new warning for these patients to heed. In 2015, they cautioned that Invokana was linked to an increased risk of bone fractures, followed by the increased risk of acute kidney damage, last year. Now, the warning box will include notices of the increased risk for lower limb amputations.
In clinical trials, the amputation risk was equal to 5.9 out of 1,000 for patients taking canagliflozin and only 2.8 out of every 1,000 for those taking the placebo. Due to these findings, not only is the FDA issuing this new warning, they also suggest talking to your medical provider immediately if you notice new pain or tenderness, sores or ulcers, or infections in your legs or feet.
If you have suffered injuries from an unsafe or defective product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.