Following the mass litigation surrounding diabetic incretin therapy drugs such as Byetta, Januvia and Victoza, newly introduced diabetic drugs tend to be met with a certain amount of skepticism. After an all-out marketing campaign, touting the incretin drugs as the newest, best drugs for the diabetics, it was found that the drugs could cause bladder cancer among patients. Invokana was the first of its kind for Type 2 diabetes, working in an entirely different manner than prior diabetes drugs.
Invokana received FDA approval in 2013, by a 10-5 vote, although the panel added a requirement for Janssen and Johnson & Johnson to conduct five post-market clinical trials in addition to the nine clinical trials the manufacturer presented in order to gain FDA approval. As has been seen with many other drugs, the clinical trials done by the manufacturer of a drug tend to seriously downplay any safety concerns associated with the drug, thanks to the lucrative nature of prescription drugs. This is clearly shown by the fact that since the approval of Invokana, there have been a significant number of Invokana amputations, Invokana kidney disease, and Invokana ketoacidosis cases among those taking the drug.
Clinical Trials for Invokana
The initial clinical trials for Invokana found that during the first thirty days patients took Invokana, there was an increased risk of cardiovascular events such as stroke and heart attack. This risk appeared to diminish after the initial thirty-day period, however both LDL and HDL cholesterol levels rose in many test patients, and, an increase in cholesterol is a well-known side effect of Invokana. The five required trials included a study on cardiovascular health for those taking Invokana, a trial which studied the risks of pancreatitis, liver disorders, kidney failure and cancer among those taking the drug, two pediatric trials and one study on bone safety for those taking Invokana.
How Invokana Works
Unlike other diabetic drugs, Invokana attacks blood sugar immediately, reducing the amount of sugar absorbed from food into the bloodstream. The body is then able to flush excess sugar from the urine. Invokana blocks sodium-glucose co-transporter 2, an integral membrane protein, from returning the sugar which is removed from the kidneys back into the bloodstream. The Invokana label did state that Invokana is contraindicated for those with renal impairment or those currently on dialysis. Those with impaired renal function must have those functions monitored during Invokana therapy. In 2017 a Black Box warning was added to the labeling of Invokana, warning those taking the drug of an increased risk of leg and foot amputation.
Most Common Adverse Reactions to Invokana
The most common adverse reactions to Invokana include urinary tract infections and yeast infections. Labeling states that no adequate studies exist for pregnant women, therefore Invokana should be used only if the benefits justify any potential risk to the fetus. Nursing mothers should not use Invokana, and among the elderly there appears to be a higher incidence of adverse reactions. Some people taking Invokana may experience symptoms of low blood sugar including headache, drowsiness, weakness, dizziness, hunger, confusion, irritability, sweating, rapid heartbeat and shakiness or jittery feelings.
Johnson & Johnson’s Hope for Invokana
Following the DePuy metal hip recall and subsequent thousands of lawsuits, Johnson & Johnson was hoping for a solid win with Invokana. While J & J did not break down Invokana sales specifically, the company’s first quarter 2014 sales—after releasing Invokana—were up over 15%, a figure many attributed to Invokana sales. As the first SGLT2 inhibitor to reach the public, Johnson & Johnson definitely had a first-to-market advantage, even though a second similar drug, Farxiga, was approved in December 2013 Farxiga quickly garnered a portion of the market before experiencing troubles similar to those of Invokana. Merck and Pfizer were in phase 3 trials for a diabetes drug which worked in the same way as Invokana, and Eli Lily co-developed an SGLT2 drug with Boehringer Ingelheim.
Other Dangerous SGLT2 Drugs
Following FDA approval of Invokana in 2013, other SGLT2 drugs were quickly approved by the FDA and marketed to the public, including Farxiga, Glyxambi, Jardiance and Xigduo XR. Many of these drugs have also caused adverse reactions in those taking the drugs, including ketoacidosis, kidney failure and cardiovascular issues. Ketoacidosis is a very serious illness, with symptoms including difficulty breathing, nausea, extreme sleepiness, extreme fatigue, confusion, vomiting and abdominal pain.
If not immediately treated, ketoacidosis can lead to death. The same mechanism which allows SGLT2 inhibitors to work by blocking the kidneys from reabsorbing glucose, causing some of the glucose to be excreted from the body through the urine, can also increase the risk of kidney problems and UTIs. The signs and symptoms of kidney failure include a reduced amount of urine, nausea, confusion, pain and pressure in the chest, coma, seizures, excessive fatigue or drowsiness, unexplained shortness of breath and swelling in the feet, ankles and/or legs.
Where to Turn If You Need Invokana Legal Help
Invokana lawsuits are stacking up quickly. There is a current Invokana MDL in New Jersey, with additional lawsuits filed across the country for Invokana harm. The Invokana Injury Attorneys at our firm are currently investigating the claims of those individuals who have been harmed by Invokana. We understand that those who need Invokana legal help are likely anxious about their health and their future. In the event you have suffered problems associated with Invokana, you need to be aware of the Invokana claim preservation process as well as the Invokana statute of limitations. Our Invokana injury lawyers have extensive experience helping those who have been injured by a defective medical device or a dangerous drug.