Hot on the heels of a growing number of Invokana side effect lawsuits, now comes disturbing medical research that links Invokana use to leg amputations.
Invokana lawsuits have been growing over injuries associated with the new diabetes drug, which has been on the market since 2013. The plaintiffs have similar allegations, claiming that the drug manufacturers placed profits before patient safety by failing to research the diabetic medication before it was released.
FDA Warns About Invokana Risks
Invokana (canagliflozin) was approved in March 2013, it is a new class of diabetes drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Johnson & Johnson aggressively marketed the drug, as a superior treatment for type 2 diabetes.
SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
In May 2015, the FDA investigated the link between Invokana and ketoacidosis, after noting 20 reports of patients being hospitalized due to diabetic ketoacidosis injuries with the drug.
The FDA required Johnson & Johnson to add new Invokana warnings about diabetic ketoacidosis in December 2015, warning patients to stop taking the drug and seek immediate medical attention if they develop abdominal pain, fatigue, nausea, respiratory issues or vomiting, all symptoms of diabetic ketoacidosis.
The FDA Adverse Event Reporting System (FAERS) database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors. FAERS includes only reports submitted to FDA, so there are likely additional cases about which the FDA was unaware. All patients required hospitalization or treatment in an emergency department.
In many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases.
FDA investigators identified reports of kidney failure and other problems that they suspected were caused by the medication. Other members of the SGLT2 inhibitor class of diabetes drugs include Invokamet, Farxiga, Xigduo, Jardiance and Glyxambi.
The FDA on May 18 issued a safety alert about the diabetes medicine Invokana, and Invokamet). An ongoing clinical trial has found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the drug.
In the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS), over 1 year, amputations occurred in seven out of every 1,000 patients treated with 100 mg daily of canagliflozin, five out of every 1,000 patients treated with 300 mg daily and three out of every 1,000 patients treated with placebo.
This latest FDA warning comes after European regulators also sounded the alarm. The European Medicines Agency (EMA) announced it was also launching an Invokana safety review regarding reports of amputations.
The FDA has not determined whether Invokana increases the risk of leg and foot amputations, it is currently investigating the issue and will update the public when it has more information.
What is Diabetic Ketoacidosis?
Diabetic ketoacidosis is a serious complication of diabetes that occurs when your body produces high levels of blood acids called ketones. This develops when the body can’t produce enough insulin. Insulin plays an essential role in helping sugar (glucose) — a major source of energy for muscles and other tissues — enter the cells. Without enough insulin, the body begins to break down fat as fuel. This process produces a buildup of acids in the bloodstream called ketones, eventually leading to diabetic ketoacidosis if untreated.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.