Invokana® (canagliflozin), Invokamet (canagliflozin + metformin), and Invokamet XR (canagliflozin + metformin hydrochlorie) are prescription drugs used to treat Type 2 Diabetes. These drugs are of the gliflozin class or subtype 2 sodium-glucose transport (SGLT-2) inhibitors class of drugs. These drugs work by inhibiting SGLT2, which is responsible for at least 90% of renal glucose reabsorption in the body. Blocking this transporter causes up to 119 grams of glucose per day to be eliminated through the urine, which decreases the amount of glucose in the blood. Unfortunately, patients who are prescribed these drugs may face an increased risk of severe side effects such as ketoacidosis (higher than normal levels of acid in the blood) and amputation of the leg or foot.
Increased Risk of Ketoacidosis
Ketoacidosis is a condition in which a patient’s blood is too acidic. In ketoacidosis, the body fails to adequately regulate ketone production, which causes an accumulation of keto acids in the blood, which makes the blood too acidic. This condition is most commonly seen in patients with Type 1 diabetes mellitus or in patients with prolonged alcoholism. In May 2015, the U.S. Food and Drug Administration issued a safety announcement warning that a search of the FDA Adverse Reporting System database identified 20 cases where patients were admitted to the ER with increased levels of acidity in their blood. Later that year in December 2015, as a result of an FDA Safety Review, the FDA issued another safety announcement requiring the manufacturers of SGLT2 inhibitors to update their warning labels to include warnings about ketoacidosis.
Symptoms of ketoacidosis include:
- Abnormal Smelling Breath
- Nausea and Vomiting
- Difficulty Breathing
- Unusual Fatigue
Increased Risk of Leg and Foot Amputations
In May 2016 the U.S. Food and Drug Administration released a safety announcement stating that the interim results of a clinical trial showed an increased risk of leg and foot amputations in patients taking Invokana and Invokamet. Almost exactly one year later, the FDA released another safety announcement confirming the increased risk of foot and leg amputations in patients taking Invokana and Invokamet. The FDA also included Invokamet XR in this safety warning. The 2017 announcement was based on data from two large clinical trials, the CANVAS Study and the CANVAS-R Study, which showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin. As a result of this information the FDA required the manufacturers of these medications to include a boxed warning, the FDA’s strongest and most prominent type of warning that can be added to a medication, about the risk of amputation to these products.
Symptoms that an Amputation Might be Needed
The FDA’s May 2017 safety announcement instructs patients to tell their physicians if they experience any of the following symptoms that might indicate a problem that may require an amputation:
- New Pain or Tenderness to the leg, foot or toes
- Sores or Ulcers
- Infections to the Legs or Feet
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