Type II diabetes is a life-threatening disease, and as such, those who suffer from type II diabetes often turn to medication for help in treating the illness. One such prescription medication is Invokana (canagliflozin), which helps to lower blood sugar by forcing the kidneys to remove sugar through urination. However, in June 2016, the FDA released a safety announcement which read that, based on recent reports, the FDA had revised the drug’s warning label due to risks of kidney harm.
In May 2017, the FDA released a FDA Drug Safety Communication confirming an increased risk of leg and foot amputations with diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). Based on the the data from two large clinical trials, the FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the drug label to describe the risk .
Invokana & Kidney Failure – What You Need to Know
Invokana has been associated with acute kidney failure, hence the change in the black box warning label. The signs of acute kidney failure include swelling in the feet and legs, and a decrease in urine production. As the failure progresses, other symptoms may include vomiting, nausea, fatigue, cramping, and even decreases in mental clarity. When untreated, kidney failure can lead to death.
How Dangerous Is Invokana?
It’s not just kidney failure that those taking Invokana may need to be worried about – the drug has also been associated with diabetic ketoacidosis, heart attacks, and leg amputations.
Ketoacidosis is a serious medical condition involving high levels of ketones being produced in the body due to insufficient levels of insulin. Ketoacidosis can result in a diabetic coma, long hospitalization and even death.
Those who have suffered kidney failure or other serious complications as a direct result of Invokana have filed suit against the drug’s maker, Janssen Pharmaceuticals, Inc. The suits allege that the company manufactured a drug unsafe for patient use, and failed to disclose of known risks.
Your Rights If You Have Been Impacted
If you have taken Invokana and suffered harm, or if you have lost a loved one to this dangerous drug, you have the right to take legal action. When you contact the law firm of Napoli Shkolnik PLLC, our attorneys will review your case for free, and provide you with legal counsel moving forward. To learn more about your options and what types of compensation may be available to you, contact our team today.