Invokamet, Invokana Amputation Lawyer
The team at PBC is investigating claims for type 2 diabetes patients who have taken Invokamet or Invokana and are experiencing pain, soreness, and/or infection in their feet or legs, or patients who have already had an amputation of their toe, foot, or leg after use of these drugs.
The FDA’s Safety Alert on Amputation Risk From Invokamet, Invokana
In a newly released safety alert, the FDA warns of an increased risk of foot and leg amputations resulting from the use of canagliflozin, the active ingredient in Invokamet and Invokana, two commonly used diabetes drugs. The safety alert stems from the FDA’s review of the final results from two clinical trials that studied the drugs and its long-term effects over a large subset of type 2 diabetes patients.
The final results from the two clinical trials found the amputation risk to be 7 out of 1,000 patients who were treated every day with 100 mg canagliflozin, and 5 out of 1,000 patients who were treated daily with 300 mg canagliflozin.
The FDA has found that diabetes patients taking Invokamet or Invokana have double the risk of having their toe, foot, or leg amputated. The agency is requiring that new warnings, including the Black Box Warning, be added to all canagliflozin drug labels detailing this amputation risk. The FDA’s Black Box Warning is reserved for only the most serious possible risks.
What are the Symptoms?
Patients should immediately seek medical attention if they have any of the following symptoms in their feet or legs:
Resulting amputations have most often involved the toe as well as the middle of the foot, while some have also involved a total leg amputation, above and below the knee. Some patients have been forced to undergo a second amputation, and some lost both of their limbs.
PBC is currently reviewing amputation cases in all 50 states. If you or a loved one were forced to have your toe, foot, or leg amputated after taking Invokana or Invokamet, contact us at (888) 725-2477 immediately.