What is Invokamet?
Invokamet contains canagliflozin and metformin, oral diabetes medications that help control blood sugar levels in patients with type 2 diabetes. Canagliflozin works by helping the kidneys expel glucose from the blood through the urine. Invokamet is made by Janssen Pharmaceuticals (a Johnson & Johnson company), and was approved by the U.S. Food & Drug Administration (FDA) on August 8, 2014.
What Serious Side Effects has Invokamet Been Linked to?
Invokamet belongs to a class of type 2 diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which have been linked to the following serious side effects:
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Ketoacidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Kidney Failure (Renal Failure) / Kidney Cancer / Kidney Infections (Pyelonephritis)
- Kidney Stones
- Amputations of the leg, foot, toe
- 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
- Yeast Infections (both men and women)
Are There Other Side Effects?
Other, less severe side effects of Invokamet may include:
- Abdominal or stomach discomfort
- Bladder pain
- Bloody or cloudy urine
- Decreased appetite
- Difficult, burning, or painful urination
- Fast, shallow breathing
- Frequent urge to urinate
- Frequent urination
- General feeling of discomfort (malaise)
- Increased urge to urinate during the night
- Increased volume of pale, dilute urine
- Itching of the vagina or genitals
- Itching, stinging, or redness of the vaginal area
- Lower back or side pain
- Muscle pain or cramping
- Shortness of breath
- Thick, white vaginal discharge with mild or no odor
- Unusual tiredness or weakness
- Waking to urinate at night
Has the FDA Issued a Warning on Invokamet?
- September 10, 2015 – Invokamet and Invokana labels updated to note that the drugs may increase the risk of bone fracture and decrease bone mineral density. According to the warning, fractures may occur in as little as 12 weeks after initiating treatment.
- May 15, 2015 – FDA issues a Drug Safety Communication regarding an increased risk for diabetic ketoacidosis (DKA) with SGLT2 inhibitor diabetes drugs. The agency received at least 20 reports of DKA in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All cases required hospitalization or an emergency room visit to treat, according to the FDA. Since this warning, the agency has continued to receive reports of diabetic ketoacidosis in SGLT2 inhibitor users.
- May 18, 2016 – FDA warns of an increased risk of leg, foot and toe amputations with canagliflozin. The warning was issued in response to an interim analysis of the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS), which found the amputation risk to be roughly: 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.
What is Diabetic Ketoacidosis?
Diabetic ketoacidosis is a severe complication of diabetes that occurs when the body produces high levels of blood acids called ketones. The condition develops when the body is unable to produce enough insulin, which helps sugar (glucose) enter the cells. Without enough insulin, the body starts breaking down fat as fuel, which causes a buildup of acids in the blood called ketones, eventually leading to DKA if left untreated.
Signs and symptoms of diabetic ketoacidosis include:
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal pain
- Weakness or fatigue
- Shortness of breath
- Fruity-scented breath
Has Invokamet Been Recalled?
Invokamet is a new drug, and no recall has been issued for it or any other SGLT2 inhibitor. However, the investigation into the health risks involved with this class of medications is still in its early stages, and it often takes many years and thousands of hours of investigation for all the facts to come out which may ultimately result in a recall.
Have There Been Any Settlements?
The first lawsuits alleging injuries from Invokamet were filed in mid-2015, and the litigation is still in its early stages. It will likely be some time before J&J considers settling cases. However, we feel that the company will eventually be required to pay substantial compensation as a result of its decision to place profits ahead of safety when they failed to adequately warn about Invokamet’s serious side effects.
What are Invokamet Lawsuits Alleging?
Invokamet lawsuits allege that Janssen and J&J:
- Failed to study Invokamet side effects
- Failed to adequately warn about the risk of diabetic ketoacidosis (DKA), kidney failure, amputations and other side effects from Invokamet
- Misrepresented the risks and safety of the drug
- Failed to Issue a recall