Complications from Invokana® Use
A growing number of patients have reported complications from Invokana®, a diabetes medication, leading many to file claims against the manufacturer. Lawsuits accuse Janssen Pharmaceuticals of failure to warn patients and doctors about risks that include diabetic ketoacidosis, kidney failure, heart attacks, and more. The corporation has also been accused of negligence, manufacturing a defective drug, and misrepresentation.
If you are one of the many people who have experienced complications after taking Invokana®, Invokamet®, or another similar drug, you may be entitled to significant compensation. Please contact an experienced pharmaceutical attorney today to schedule a complimentary consultation and case review.
Invokana® is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that is recommended for patients with type 2 diabetes mellitus. SGLT2 inhibitors are intended to help patients improve glycemic control and reduce blood glucose levels. Invokana® stimulates the kidneys to remove excess sugar from the patient’s bloodstream. Janssen’s other drug in this class, Invokamet®, combines the active ingredient in Invokana® with metformin, another type 2 diabetes medication used to control blood sugar. Both of these drugs, along with other SGLT2 inhibitors, have been associated with an increased incidence of dangerous complications.
The most commonly reported adverse incidents are diabetic ketoacidosis and kidney failure, but lawsuits have also alleged that the drug has caused heart attacks and strokes.
In May 2015, the nonprofit Institute for Safe Medication Practices (ISMP) issued a warning concerned with the number of adverse reaction reports among users of Invokana®. The ISMP’s publication, Quarter Watch, reported 457 serious events filed with the U.S. Food and Drug Administration (FDA) within the first year of Invokana®’s release. The ISMP later reported that 5,484 adverse health events associated with Invokana® had been reported in 2015.
Frequently Reported Complications
The most commonly reported adverse incidents are diabetic ketoacidosis and kidney failure, but lawsuits have also alleged that the drug has caused heart attacks and strokes. Adverse event reports to the FDA have included severe dehydration, kidney stones, urinary tract infections, abnormal weight loss, and allergic reactions, including swelling of the lips, face, and throat.
Diabetic ketoacidosis is a condition that can occur when acid builds up in the bloodstream. In diabetic patients, inadequate levels of insulin in the body can deprive cells of sufficient glucose to provide energy. The body then breaks down fat for energy, which produces toxic acid in the blood, called ketones. Diabetic ketoacidosis can lead to diabetic coma, and can even be fatal in severe cases. In patients taking Invokana®, the disorder is presenting without observable levels of high blood sugar, making it more difficult to diagnose and increasingly dangerous.
In 2015, the ISMP identified 168 cases of diabetic ketoacidosis in Invokana® patients that had been reported to the FDA. Many Invokana® lawsuits involve cases of diabetic ketoacidosis reported by doctors and patients. One example is a case filed in December 2015, by a plaintiff who developed diabetic ketoacidosis shortly after beginning to take Invokana®. Her complaint cites Janssen’s dangerous off-label promotion of the drug for treatment of hypertension.
A number of cases filed in the Invokana® lawsuit are related to kidney failure or kidney damage. The kidneys perform a very important function in the body: filtering waste products from the blood. If kidney function is compromised, waste products will begin to accumulate in the bloodstream, putting the patient at risk for a number of dangerous conditions. Acute renal failure can lead to permanent kidney damage, which may require ongoing dialysis or an organ transplant. The condition can ultimately be fatal in some patients.
Examples of these plaintiff lawsuits include a case filed in Kentucky in February 2015. A female patient took her prescribed medication for three and a half months before being hospitalized with kidney failure. In a Tennessee case filed in December 2015, a male patient blames Invokana® for his permanent kidney damage and reduced kidney function, with lifelong complications anticipated.
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Heart Attack and Stroke
A myocardial infarction, or heart attack, is caused by a blockage of blood flow in the arteries, which deprives the heart of oxygen and causes the permanent death of cells. Similarly, a stroke is caused when a blockage inhibits blood from reaching the brain.
Some patients have experienced cardiac complications, heart attacks, and strokes while taking SGLT2 inhibitors. As reported in a March 2013, New York Times article, clinical trials for Invokana® revealed signs of an elevated stroke risk, as well as a small increase in heart attacks within 30 days of taking the drug. The FDA approval panel noted this, and asked Johnson & Johnson to conduct a post-marketing clinical trial to explore these risks.
Bone Fractures and Other Complications
In September 2015, the FDA began requiring updated warning labels on SGLT2 inhibitor medications to include information about the increased risk of bone fractures and reduced bone mineral density. Within 12 weeks of starting these medications, patients have experienced more than the expected number of hip and spine fractures, which can cause extended immobility and other complications.
Patients taking Invokana® are at greater risk for serious urinary tract infections that may require hospitalization. Other side effects may include dehydration and yeast infections. Invokamet® is also associated with lactic acidosis, a potentially serious condition that requires emergency medical treatment.
Marketing a Blockbuster Drug
Janssen Pharmaceuticals, a division of Johnson & Johnson corporation, spent $19.8 million marketing Invokana® in 2014, and over one million prescriptions had been written by June of that year. The return on the company’s investment of marketing dollars has been substantial; Invokana® has achieved “blockbuster status” in the pharmaceutical industry, with sales of over a billion dollars in one year. Invokana® and Invokamet® together brought in $278 million for the first quarter of 2015 alone.
Some lawsuits filed against Janssen allege that the company promotes Invokana® as an off-label treatment for weight and blood pressure control.
Current lawsuits filed against Janssen allege that the company promotes Invokana® as an off-label treatment for weight and blood pressure control. The Invokana® website specifically states that the drug demonstrates “superior reduction in body weight” in comparison to another drug. The Invokamet® site claims that “adults with type 2 diabetes can lose, on average, three percent body weight and may see their systolic blood pressure lowered.”
A December 2013, MedPage article specifically promoted Invokana® for weight loss soon after the drug was introduced. Entitled “Diabetes Drug Helps the Obese Shed Some Weight,” the story reported on a study sponsored by Janssen Pharmaceuticals, which credited Invokana® with “statistically significant reductions in body weight from baseline compared with placebo.”
Liability and Compensation
A growing number of Invokana® lawsuits claim that Janssen Pharmaceuticals is liable for manufacturing a defective drug, and allege negligence, failure to warn, fraudulent misrepresentation, and other charges. Compensation for injuries caused by drug complications can be substantial, including reimbursement for medical expenses, lost wages, and pain and suffering.
A class action lawsuit was filed in Canada in September 2015, which now includes dozens of claimants. In the United States, many individual cases have been filed across the country since that time. There is growing potential for multidistrict litigation (MDL), which is often employed as an alternative to class action in these types of cases.
MDL allows for combined discovery when there are multiple individual plaintiffs filing legal action against a single defendant. However, each party is still represented by his or her own attorney, and can expect an individualized settlement or verdict.
Contact a Product Liability Attorney
If you or a loved one has experienced a serious complication while using Invokana®, Invokamet® or another SGLT2 inhibitor, you may be entitled to compensation. Qualified pharmaceutical attorneys are offering complimentary case evaluations, providing an opportunity to discuss your case and learn your legal options.