The U.S. Food & Drug Administration (FDA) is warning that the type 2 diabetes medication Invokamet (canagliflozin/metformin HCl) has been linked to an increased risk for leg, foot and toe amputations.
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.
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.
What’s the Problem?
May 18, 2016 – The FDA warning followed interim results of the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) trial, which found that amputations occurred roughly twice as often in patients treated with canagliflozin (the active ingredient in Invokamet and Invokana) compared to those treated with a placebo. Specifically, the risk of amputation was equivalent to 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.
FDA noted that the study did not determine conclusively that canagliflozin causes amputations, but rather identified a correlation. Additional research will be needed to assess whether the drug is actually responsible for the increased 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 have also been advised to seek immediate medical attention if they experience any pain, tenderness, sores or ulcers in their legs or feet.
“We are continuing to evaluate this safety issue and will update the public when we have more information,” the agency concluded.
EMA Investigates Amputation Risk
Safety regulators with the European Medicines Agency (EMA) have requested more data from Janssen Pharmaceuticals about the increased risk of amputations with canagliflozin. EMA could recommend changes to the way the drug is prescribed in Europe if the increased amputation risk is confirmed.
Type 2 Diabetes & Foot Complications
Diabetes patients are already prone to a wide variety of foot problems, according to the American Diabetes Association (ADA). These complications typically occur when the patient suffers damage to their peripheral nerves, a condition referred to as peripheral neuropathy. This causes tingling, pain and/or weakness in the foot. It can also cause loss of feeling in the foot, so patients can injure themselves and not even know it. Poor blood flow or changes in the shape of your feet or toes may also lead to problems, according to the ADA.
How to Avoid Amputations
If you take Invokamet and are worried about the possibility of an amputation, you should talk to your doctor about alternative courses of treatment. However, you should never switch or quit taking a medication without consulting your physician first.
Other things you can do to reduce your amputation risk include:
- Check your feet for blisters, cuts and infections daily.
- Quit smoking if you’re a smoker. Cigarette smoking is a 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 has previously been linked to the following serious side effects:
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Acidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Infections (Pyelonephritis)
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
Do I Have an Invokamet Amputation Lawsuit?
The Pharmaceutical 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 were forced to have your leg, foot or toe amputated after taking Invokamet, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.