Invokana Risk of Amputation Warning. Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has issued a warning against type 2 diabetes medicine canagliflozin, sold under the brand names Invokana, Invokamet, and Invokamet XR. The new warnings will mandate that Johnson & Johnson add the most prominent Boxed Warning to the canagliflozin drug labels to describe the risk of increased potential of leg and foot amputations.
The two clinical trials, the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus), showed that leg and foot amputations occurred about twice as frequently in patients treated with canagliflozin compared to patients treated with a placebo. Most common were amputations of the toe and middle of the foot, but amputations involving the leg, below and above the knee, also occurred. In some cases, more than one amputation was necessary, according to the FDA.
Update to 2016 MedWatch Safety Alert
This new information is an update to the May 18, 2016 MedWatch safety alert. Canagliflozin is a prescription drug used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It is part of a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the excretion of urine.
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Increased Risk of Amputation due to Diabetes Drugs
Results showed that 5.9 out of every 1,000 patients treated with canagliflozin underwent some amputation, compared to 2.8 out of every 1,000 patients treated with placebo who also underwent amputation. Of the patients who underwent amputations, 99 out of 140 receiving canagliflozin had their toe or mid-foot removed, while amputations involving the leg and the knee accounted for 41 out of 140 amputations. Some patients underwent more than one amputation, according to Pulse Headlines.
Now regulators say doctors should “consider factors that may predispose patients to the need for amputations,” such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, before prescribing Invokana, FiercePharma reports.
If left untreated, type 2 diabetes can lead to kidney damage, heart disease, and blindness. The doctor should also inform the patient how canagliflozin is linked to an increased risk of amputation. The European Medicines Agency advised in a statement in February, “Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine preventative foot care. They should also tell their doctor if they notice any wounds or discoloration, or if their feet are tender or painful.”
Canagliflozin Side Effects
As with all medications, there are side effects and benefits must be weighed against risks. Caniglaflozin can cause hypotension, ketoacidosis, kidney problems, a large amount of potassium in the blood, urinary infections, high cholesterol, yeast infections, bone fractures, and low blood sugar, if combined with other drugs taken for treating diabetes.
Invokana Ketoacidosis Lawsuits
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and Mitsubishi Tanabe are already involved in product liability lawsuits over Invokana. Plaintiffs allege that the type 2 diabetes drug causes a condition called ketoacidosis, where the blood is too acidic. Plaintiffs allege that the companies failed to sufficiently warn of the risks associated with the drugs.
FDA Warnings Concerning Invokana
The U.S. Food and Drug Administration (FDA) approved Invokana in 2014. In patients with diabetes, the body is unable to properly break down sugar for energy. When sugar cannot be utilized, the body resorts instead to fat for energy. This results in the production of ketone bodies, which accumulate in the blood and makes the blood more acidic.
The FDA’s adverse event reporting database shows that patients taking Invokana are more likely to suffer from diabetic ketoacidosis (DKA) than are those taking non-SGLT2 diabetes drugs. Signs of ketoacidosis are frequent urination, excessive thirst, nausea and vomiting, abdominal pain, shortness of breath, fruity-scented breath, and confusion, according to the Mayo Clinic.
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