The U.S. Food & Drug Administration (FDA) has issued a safety alert regarding an increased risk of leg and foot amputations — mostly affecting the toes — associated with canagliflozin, the active ingredient in Invokamet.
Update: FDA Requires Boxed Warning on Amputation Risk with Invokamet
May 16, 2017 – Based on the final results of 2 long-term clinical trials, FDA has concluded that type 2 diabetes patients who take Invokana or Invokamet are twice as likely to have their foot or toe amputated. As a result of these findings, the agency is requiring that both medications carry a boxed warning regarding the amputation risk.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
May 18, 2016 – FDA’s warning was issued in response to the interim results of an ongoing clinical trial which determined the amputation risk to be:
- 7 out of every 1,000 patients treated daily with 100 mg canagliflozin;
- 5 out of every 1,000 patients treated daily with 300 mg canagliflozin, and
- 3 out of every 1,000 patients treated with placebo.
The alert comes just weeks after the European Medicines Agency (EMA) announced that it was investigating reports of lower limb (mainly toe) amputations with the drug.
FDA cautioned that the study did not conclusively prove that Invokamet causes amputations, but rather identified a link. Further studies will be required to investigate whether the medication is actually responsible for the amputation risk, and the agency has asked patients not to stop taking the drug in the meantime.
“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” FDA said. “Doing so can lead to uncontrolled blood sugar levels that can be harmful.”
Patients should seek immediate medical attention if they experience any pain, tenderness, sores or ulcers in their legs or feet, according to the FDA.
Why are Amputations Performed on Diabetes Patients?
Most amputations are carried out on diabetics who have severely reduced blood circulation in one of their feet as a result of complications of the disease, according to the American College of Foot and Ankle Surgeons. Diabetes can cause a person’s blood sugar levels to become too high, which can result in nerve damage (peripheral neuropathy) — particularly in the feet.
Neuropathy can reduce sensations in the feet, meaning that a person can injure their foot without even realizing it. Blood vessel damage can also restrict blood supply to the feet, making ulcers take longer to heal and prone to infection. These infections can spread rapidly through the foot and up into the leg, and an amputation may be required to avoid further spreading.
How to Avoid Amputations
- Talk to your doctor about switching from Invokamet to another diabetes medication with fewer potential side effects.
- Check your feet for blisters, cuts and infections daily.
- Quit smoking if you’re a smoker. Cigarette smoking is a huge risk factor for diabetic foot disease.
- Watch your blood sugar. People with type 2 diabetes who lower their blood glucose are at reduced risk for neuropathy.
- Choose shoes carefully.
- Cut and file your toenails regularly, or have someone else do it if you already have numbness.
Invokamet Side Effects
Invokamet was approved in August 2014 as a type 2 diabetes drug belonging to the sodium-glucose cotransporter-2 (SGLT2) inhibitor class of medications. SGLT2 inhibitors work by lowering blood sugar by causing the kidneys to remove sugar from the body through the urine.
On May 15, 2016, FDA issued a safety alert regarding an increased risk of diabetic ketoacidosis, or DKA, associated with SGLT2 inhibitors like Invokamet. Other side effects linked to Invokamet include chronic kidney disease, kidney failure, heart attack, bone fractures and more.
Do I Have an Invokamet Amputation Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokamet lawsuits. We are handling individual litigation nationwide and currently accepting new amputation cases in all 50 states.
Free Confidential Case Evaluation: Again, if you required an amputation after taking Invokamet, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.