Johnson & Johnson unveiled their diabetes drug, Inokana (canagliflozin) several years ago. Unlike other diabetic drugs, Invokana worked by attacking blood sugar immediately, reducing the amount of sugar absorbed into the bloodstream from food. The body then flushed any excess sugar out in the urine. Invokana’s primary action occurred in the kidneys, as it blocked sodium-glucose co-transporter 2 (an integral membrane protein). Because Invokana worked in the kidneys, some members of the FDA panel who granted approval for the drug expressed concern regarding those with kidney disease taking the drug.
The trials conducted by Johnson & Johnson noted an elevated risk of stroke and heart attack during the first thirty days, however after that initial thirty days, the risk appeared to diminish. Invokana was also found to raise both LDL and HDL cholesterol levels—both the “good” and the “bad” cholesterol in the body. Those who have suffered serious Invokana kidney damage, Invokana ketoacidosis or Invokana amputations should strongly consider consulting an experienced Invokana injury lawyer as soon as possible.
There are four types of diabetic drugs currently on the market:
- Biguanide drugs like Metformin work by increasing insulin sensitivity.
- Thiazolidinediones medications such as Avandia and Actos increase insulin sensitivity and decrease insulin resistance.
- Incretin therapy drugs such as Byetta, Januvia and Victoza are now the focus of mass litigation due to an increased risk of pancreatic cancer.
- Sodium-Glucose Co Transporter 2 Inhibitors, including Invokana, Farxiga, Glyxambia, Jardiance and Xigduo XR.
Invokana, as well as Farxiga, Glyxambi, Jardiance and Xigduo XR have all had similar problems; Farxiga has been linked to diabetic ketoacidosis, kidney failure, heart attack and bone fractures and Glyxambi has been linked to diabetic ketoacidosis. Farxiga and Xigduo XR litigation has been centralized for pretrial handling in the southern district of New York.
Diabetes Among Americans
While diabetes drugs, as a whole, save lives, they also represent one of the four types of prescription drugs responsible for over 66% of ER visits among older Americans. Over 25% of adults in the United States over the age of 65 currently live with diabetes. Overall, 11.3% of all Americans over the age of 20 have diabetes, and a staggering one third have pre-diabetes. About 90-95% of all those with diabetes have Type 2 diabetes, which is the type Invokana is designed to treat. When left untreated, diabetes can lead to serious complications. Controlling blood sugar prevents the serious side effects of diabetes such as heart attack, stroke, renal damage, nerve damage and vision loss.
FDA Approval of Invokana
The FDA approved Johnson & Johnson’s new diabetic drug, Invokana, in March, 2013 as a single agent meant to be used in conjunction with diet and exercise to lower blood sugar among those adults with Type 2 diabetes. Johnson & Johnson’s application for Invokana cited nine clinical trials with over 10,000 patients. Primary side effects were yeast infections and urinary tract infections. Some people taking Invokana noted dizziness or faintness upon standing, which could cause potential problems in the elderly. Because other diabetic drugs have had issues related to an increase in heart attack risk, the FDA required Johnson & Johnson to conduct an additional five long-term studies regarding the effect Invokana has on cardiac health, pancreatic disorders, cancer and liver problems. These studies found serious issues associated with Invokana.
Invokana is an oral medication, taken once daily; those taking diuretics, drugs used to treat or prevent tuberculosis, seizure medication such as phenobarbital, drugs used to treat HIV, or digoxin used to treat heart problems should speak to their doctor regarding the risks associated with these conditions combined with Invokana. Those taking Invokana may develop symptoms of low blood sugar such as headache, dizziness, weakness, drowsiness, confusion, hunger, irritability, shaking or jittery feelings, sweating, rapid heartbeat or serious allergic reaction.
Potential Dangers Associated with Invokana
Since Invokana received FDA approval, more and more people taking the drug have experienced problems associated with the drug. In May of this year, the FDA ordered J & J to include new warning labels on Invokana which inform those taking the drug that they may face a higher risk of amputation while taking Invokana. This information came from two clinical trials which clearly demonstrated a higher risk—two times as high—of leg and foot amputations among those taking Invokana. The warnings on the drug are black box warnings—the highest level of warning placed on a prescription drug. While there has been no recall associated with Invokana, the FDA has warned caution to those taking the drug, in particular:
- Any infections, ulcers, sores or new pain or tenderness while taking Invokana should be taken very seriously. Notify your doctor if you experience any of these symptoms.
- Those with a history of diabetic foot ulcers, neuropathy, peripheral vascular disease or amputation could have a higher risk of amputation while taking Invokana.
- Do not simply stop taking Invokana, without discussing your risk for Invokana amputation, Invocana kidney damage and Invokana ketoacidosis with your physician.
Did Johnson & Johnson Hope To Gain a Measure of Redemption With Invokana?
While Johnson & Johnson is a multi-billion-dollar company, their reputation has taken a number of hits over the past few years. The DePuy metal-on-metal hip recall definitely cast a tarnish on the company, and the more recent talcum powder lawsuits have continued that tarnish. J & J was hoping Invokana would restore the company’s reputation. While this doesn’t seem to be the case, the drug definitely helped lift Johnson & Johnson’s first quarter sales in 2014; J & J posted a 15% growth in the first quarter, reaching nearly $300 million. As the first SGLT2 inhibitor to gain FDA approval, Invokana definitely had a first-to-market advantage, however it now looks like the company should have taken more time to conduct clinical trials to ensure the drug’s safety.
Merck and Pfizer developed their own SGLT2 inhibitors and Eli Lilly co-developed an SGLT2 inhibitor drug with Boehringer Ingelheim, however the company had to deal with a rejection letter which cited concerns with one of Boehringer’s manufacturing plants. Knowledgeable industry experts believe Invokana could achieve peak sales of over $2 billion. Those who suffered from diabetes were likely very happy to see a new diabetes drug like Invokana which had the potential to control the disease with few side effects—at the time.
Getting Help for Invokana Injuries
Of course, other diabetes drugs have debuted to the same type of fervor, only later to find there were serious adverse side effects associated with the drugs. While Invokana lawsuits are awaiting trial in an MDL in New Jersey, Takeda’s Actos, another diabetes medication which was responsible for serious health issues, was the subject of a $2.4 billion settlement in 2015—a settlement which is likely to increase the chances of success for Invokana plaintiffs, even though Actos works in a bit of a different manner. If you are one of the many Invokana patients who have suffered Invokana ketoacidosis, Invokana kidney damage or Invokana amputations, don’t put your future further in jeopardy—call an experienced Invokana injury lawyer today.