Type 2 Diabetes
Nearly 3 million Americans suffer from type 2 diabetes, a condition that prevents the body from thoroughly processing food into insulin, and causes the blood to overload with glucose. Diabetes has been associated with various health issues including heart disease, blindness, kidney failure, and amputations.
Unlike type 1 diabetes, type 2 diabetes can be controlled by a healthy diet and ample exercise – without the need for any medication. However, as is often the case, drug manufacturers have developed medications that take the place of us having to do the hard work associated with changing our diets and exercising. And so long as the risks are not substantial, many people will opt for the easy way out – just take a pill as prescribed by your doctor and the drug will allow the glucose to exit the body instead of building up in the system.
Invokana® and its Purpose
One drug that was created explicitly for this purpose was Invokana®. Invokana® is among a group of newer medications known as sodium-glucose co-transporter-2 or SGLT2 inhibitors. The active ingredient in Invokana® is canagliflozin. Invokamet is a similar drug that contains metformin as well as canagliflozin.
Invokana® was approved by the FDA in March 2013 for treatment of type 2 diabetes. Janssen Pharmaceuticals, a division of Johnson & Johnson, manufactured the drug, and it became popular and profitable.
Invokana® was supposed to help patients manage their diabetes by blocking the normal response of glucose being reabsorbed back into the bloodstream after it is filtered through the kidneys. Invokana®, unlike competing drugs, effectively controls blood sugar levels by allowing glucose to exit through the urine.
Unfortunately, Invokana’s® promising start in 2013 has been plagued by post-marketing evidence of serious side effects, life-threatening injuries, and fatalities, which have led to repeated warnings by the FDA and which appear more hazardous to the health of many patients who have been diagnosed with type 2 diabetes than the disease itself.
Dangerous Side Effects and Serious Injuries
Two years after the introduction of Invokana®, reports of potentially fatal side effects appeared. Patients who took Invokana developed serious side effects like decreased bone mineral density, which could result in bone fractures, urinary tract infections, and yeast infections. Although diabetics bear a higher risk for toe, foot, or leg amputations, Invokana® use virtually doubles the amputation risk, according to two clinical trials known as CANVAS and CANCAS-R. CANVAS started in 2009 before the drug was approved, and CANVAS-R was done in 2014. Both studies, originally investigating the effect of Invokana® on patients with heart disease, revealed the increased risk of toe, foot and leg amputation.
Other life-threatening side effects include heart complications, blood infections, kidney damage and failure, pancreatitis, breast and bladder cancer, and diabetic ketoacidosis (DKA). DKA creates deadly levels of acidity in the blood called ketones and can lead to diabetic comas or fatalities. At a minimum, patients who contract DKA may require significant recovery time at the hospital.
FDA Warnings Against Invokana®
In 2015, the FDA’s Adverse Event Reporting System picked up 20 cases of type 2 diabetics who, while taking SGLT2 inhibitors, had developed severe enough DKA to require hospitalization. This prompted the FDA to issue a drug safety communication to declare that SGLT2 inhibitors would require warnings about the risk of excessive blood acids. In the following months, the FDA required the manufacturer to include additional information about bone density changes, and increased bone fracture risk as well as warnings about DKA and serious urinary tract infections.
Yet another FDA warning in June 2016 cautioned consumers about the increased risk of acute kidney injury, which originated from a 2013 patient study.
The most recent warning which was issued in May 2017, forcing the drug manufacturer to add a Black Box Warning regarding the increased risk of toe, foot and leg amputations to its package label, and recommending that doctors consider other patient conditions such as neuropathy, peripheral vascular disease, foot ulcers, and prior history of amputation when deciding whether to recommend Invokana® for their patients.
How Manufacturers Failed to Protect Consumers
The manufacturers of Invokana® failed to protect their consumers by producing a dangerous and defective drug with so many devastating consequences. Claims against the manufacturer state that they failed to warn the public about the potentially lethal risks associated with Invokana® such as amputations, kidney failure, and DKA; that they overstated the benefits of the drug while understating its risks; and that they manufactured and marketed a drug that had not been properly tested.
If you or a loved one has developed medical conditions after taking Invokana®, you may require the guidance of an experienced defective drug attorney to discuss your options if this dangerous drug has interrupted your quality of life.
Dangerous drug manufacturers must be held accountable for their actions. At Williams Cedar, our dangerous drug lawyers are dedicated to protecting our clients. Call us today at 215-557-0099 and ask for Diane Fenner or contact us online to schedule a consultation if you have suffered an injury that might be assocaited with your use of Invokana®. While our offices are located in Philadelphia, Pennsylvania and Cherry Hill, New Jersey and we are dedicated to serve clients nationwide in bringing defective drug claims against drug manufacturers and distributors.