Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

The clinical trials were named CANVAS and CANVAS-R, based on long scientific acronyms. The studies examined the effects of canagliflozin on patients with Type-2 diabetes. The trials discovered that leg and foot amputations occurred twice as often in patients taking canagliflozin as those treated with a placebo.

The risk for amputations broke down like this: 5.9 out of every 1,000 patients treated with canagliflozin suffered amputation, as compared to 2.8 out of every 1,000 patients treated with a placebo. Over a year’s time, the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 out of every 1,000 patients treated with a placebo. These are statistically significant results, meaning the risk of amputation for those people taking Invokana was large enough to cause alarm in the medical community.

In the clinical trials, amputations of the toe and middle of the foot were the most common; however, amputations of the leg, below and above the knee, also occurred. Some patients had more than one amputation.

Based on this new data, the FDA ordered new warnings, including a prominent boxed warning, to be added to the canagliflozin drug labels to explain and describe this risk. more Black Box Warnings

A boxed warning is serious business. A “boxed warning” or “black box warning” is a warning that appears on the package insert for certain prescription drugs. It is given this name because the FDA requires that the warning be presented with a box or notable border around the text. The boxed warning is designed to call attention to serious or life-threatening risks that are possible when using the prescription drug.

In July 2017, the FDA required a boxed warning for the diabetes drug Invokana, which included these bullet points:

“Warning: Lower Limb Amputation”

• A 2-fold increased risk of lower limb amputations was observed in two studies of patients taking Invokana.
• Amputations of the toe and midfoot were most frequent; amputations of the leg were also observed. Some patients had multiple amputations.
• Before taking Invokana, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving Invokana for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

See FDA Website for the complete boxed warning.

The bottom line: if you are taking Invokana for treatment of Type-2 diabetes, talk to your doctor about the risks and whether you should remain on the medication. For more information, consult the FDA website.

Diabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.

Invokana: Diabetes Drug

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a subtype 2 sodium-glucose transport inhibitor marketed by Janssen, a subsidiary of Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

Problems and Side Effects of Invokana

All drugs have side effects and Invokana is no different. However, many patients who took Invokana suffered many side effects that they did not anticipate because Janssen allegedly did not warn users adequately of these side effects. Injuries claimed as a result of Invokana include:

• Diabetic ketoacidosis
• Renal failure and acute kidney injuries, even in those without a history of kidney problems
• Stroke
• Urinary tract infections, resulting in either blood or kidney infections
• Increased risk of leg and foot amputations

After its approval and release in the United States, drugs containing canagliflozin, including Invokana, were the subject of several safety announcements and warning label updates.

For example, in May 2015, the FDA issued a Drug Safety Communication telling the general public that there was a risk of diabetic ketoacidosis.

In September 2015, the FDA issued another Drug Safety Communication declaring increased safety warnings concerning the risk of bone fractures due to decreased bone density.

In December 2015, the FDA released yet another Drug Safety Communication requiring that drugs containing canagliflozin have warning labels that listed diabetic ketoacidosis and urinary tract infections.

And in May 2017 there was another Drug Safety Communication released by the FDA confirming an increased risk of leg and food amputations in those taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk. The FDA’s decision was based on two clinical studies which found that individuals taking medications containing canagliflozin had twice the risk of having a foot or leg amputated.

With all these newly discovered problems with a popular medication, it’s no wonder there is currently a flurry of lawsuits pending in the courts.

People Injured by Invokana Filing Suit

As of April 27, 2017, there were 295 Invokana product liability lawsuits in federal court. By the time you read this, that number is very likely to be higher.

Because of the varied side effects and problems with taking Invokana, the lawsuits set forth a variety of physical injuries, including stroke, diabetic ketoacidosis, urinary tract infections, kidney failure and death.

The most significant legal argument of the plaintiffs is that Janssen did not adequately warn them or their doctors of these and other risks associated with taking Invokana. Had they been warned about these risks, they could have chosen an alternative method of treating their Type 2 diabetes.

Invokana Litigation Status

The Invokana federal lawsuits have been placed into a multi-district litigation, or MDL. The purpose of this consolidation is to allow for a more efficient pre-trial litigation process and facilitate a potential settlement.

The cases are currently in the discovery phase, which will take many months to complete. The Judge overseeing the Invokana MDL hopes to have three bellwether trial cases selected by January 2018, with the first bellwether trial beginning in September of 2018.

What Happens Next?

The pretrial activities, such as discovery, will need to run their course and that can take a while. The discovery process occurs when both sides share information that may be used at trial. In large cases involving corporate defendants, the discovery process can be the most time consuming and expensive part of the lawsuit.

The FDA currently recommends patients taking Invokana and other medications containing canagliflozin to contact their doctor immediately if they’re experiencing any problems with the medication. The FDA has also told patients not to stop taking Invokana until they speak with their doctor first.

When there are additional updates to the Invokana litigation, I will post them on this blog.