Diabetes is at an all-time high in the United States, where nearly 10% of the population is estimated to have diabetes, accounting for more than 29 million people across the country. The American Diabetes Association (ADA) has reported that the number of people who have diabetes has increased more than 380 percent between 1988 and 2014.
Diabetes can have extremely serious health consequences and the ADA states that more Americans die from diabetes every year than breast cancer and AIDS combined, although the actual number of deaths may be underreported if a death is due to further complications caused by diabetes.
Of the 29 million cases of diabetes, approximately 95% consist of Type 2 diabetes, while only 5% make up Type 1 diabetes. Due to the sheer prevalence of this disease, which has impacted the friends or families of virtually all of us, many pharmaceutical companies have been rushing to produce medications for this growing and lucrative segment of the population.
Unfortunately, we have seen that some medications among the newest class of pharmaceuticals may cause side effects or complications that are so dangerous that they may outweigh the benefits they aim to achieve.
Invokana
Invokana is the brand name of a drug that is known generically as canagliflozin, which is meant to help regulate the blood sugar levels of patients with Type 2 diabetes. This drug is manufactured by Janssen Pharmaceuticals, which is a division of Johnson & Johnson.
They also make a version of the drug known as Invokamet, which includes the addition of another diabetes drug called metformin along with canagliflozin.
Both Invokana and Invokamet are classified as SLGT2 inhibitors, which is a class of drug prescribed to patients with Type 2 diabetes.
Over the past few years however, a number of very serious side effects associated with using Invokana and Invokamet have been reported, and thousands of claims have been filed against Janssen Pharmaceuticals and Johnson & Johnson for damages.
There are several possible side effects associated with these drugs, but the most serious are related to kidney damage, ketoacidosis, and amputation.
Kidney Failure
Kidneys serve to help filter waste products from the blood, and play an important role in controlling blood pressure, red blood cell production, and electrolyte balance. When kidneys no longer function properly, waste products and fluids may build in the body causing shortness of breath, lethargy, arrhythmia, and sudden death.
Invokana relies heavily on the kidneys in order to lower a person’s blood sugar levels by passing it through the urine, but this can also over-stress the kidneys and ultimately cause them to fail. Kidney failure means that the kidneys can no longer function without the use of dialysis or by receiving a kidney transplant.
Ketoacidosis
Ketoacidosis is a medical condition that occurs when the body cannot make enough insulin, which then forces the body to find other sources of energy by breaking down fat. In turn, this triggers toxic acids known as ketones to be introduced to the bloodstream.
The symptoms of ketoacidosis include difficulty breathing, frequent urination, fatigue, headaches, nausea, vomiting, abdominal pain, and confusion. If left untreated, ketoacidosis can be fatal.
Diabetic ketoacidosis has proven to be one of the most serious and difficult to diagnose since the symptoms are often difficult to identify or may be confused with other conditions, and many may not even know they suffer from the condition.
If you take Invokana or Invokamet and suffer from the symptoms listed above, you should contact your doctor as soon as possible to rule out ketoacidosis.
Amputation
There is always a risk of amputation among those with diabetes, however clinical trials have recently shown that patients taking Invokana or Invokamet may be up to twice as likely to suffer amputation as those who were taking a placebo pill.
The exact reasons for the increased risk of amputation are still not clear, but the evidence was strong enough to cause the FDA to warn the public of the dangers associated with Invokana and amputation, and to require Johnson & Johnson to print this warning on packaging for these medications.
The most common amputation by those taking Invokana is the loss of one or more toes, sometimes all at once or over the course of multiple amputations.
Other patients using Invokana have suffered amputations of a foot or of the leg, which includes both below and above the knee amputations. Any amputation is traumatic, but the loss of a foot or leg can be a devastating loss that accompanies a great deal of physical therapy, learning how to use a prosthesis, and more often than not, feelings of grief and mental anguish associated with body image and self-worth.
FDA Warnings
Canagliflozin was first approved in March of 2013, and in the years that followed, the FDA began receiving reports of ketoacidosis, kidney injury, and kidney failure among patients being treated with SLGT2 inhibitors such as Invokana and Invokamet, which prompted the FDA to warn about these side effects in 2015.
Initially the FDA warnings were limited to ketoacidosis and kidney failure, but with more time and research, studies have also demonstrated the increased risk of amputations, which compelled the FDA to issue an even stronger warning about drugs containing canagliflozin in 2017.
What was once seen as a new miracle drug in the fight against diabetes has now changed into a grimmer outlook about how much good this drug does versus the negatives it can also cause. While a drug may gain FDA approval, that is by no means a sign that the drug is completely safe.
As happens all too often, we only find out about the scale of these harmful side effects of popular pharmaceutical drugs years after they have been introduced to the public.
Invokana Claims and Lawsuits
In the years following Invokana’s release by Johnson & Johnson, the claims and lawsuits began to mount among the thousands of people that have been negatively impacted by this drug. The lawsuits are currently combined before a Federal judge in New Jersey as they undergo a discovery and evidence gathering phase.
These lawsuits argue that Invokana is defective and unreasonably dangerous, that Johnson & Johnson was negligent in the manufacturing of the drug and failed to properly test the medication, that they also failed to properly warn the public about the significant risk of ketoacidosis, kidney failure, and amputation, and finally, they argue that Johnson & Johnson concealed evidence of the dangers of the drug to both the government and public and misrepresented the safety in their marketing material.
The evidence of the negative effects of Invokana are substantial and continue to mount, yet despite the fact that thousands have suffered the severe consequences of this drug, the manufacturers continue to generate hundreds of millions of dollars in revenue, despite the dangers it poses to an often-unsuspecting public.
No amount of money can replace a missing limb or a failed kidney, but if you’ve taken Invokana and suffered as a result, then you deserve economic compensation for mounting medical bills, lost wages, and for the pain and suffering caused as a result.
If this drug has impacted you or a loved one, then it is important that you speak to an experienced medical malpractice attorney who specializes in dangerous and defective drugs. Fears Nachawati is one of the leading personal injury attorneys in Texas, and we are prepared to fight on your behalf if you’ve taken Invokana or Invokamet and suffered the serious and dangerous side effects associated with these drugs.
Having the right legal team on your side during this emotionally difficult and challenging time can mean all the difference, and we will help ensure you receive the compensation that you are entitled to because of these drugs.
For your free, no obligation legal consultation, please call (866) 705-7584, or visit the offices of Fears Nachawati located throughout the great state of Texas, including in Houston, Dallas, Austin, Fort Worth, and San Antonio.