The Status of Invokana Lawsuits

The Status of Invokana Lawsuits

Posted By Golomb & Honik, P.C. || 20-Jul-2015

A potentially fatal side effect of Invokana, as well as other SGLT2 inhibitors, is expected to lead to a flurry of lawsuits against the manufacturers of these drugs. Invokana is used in the treatment of Type II diabetes. Yet, this drug can trigger dangerous levels of blood acids, which can lead to coma and even death. After reviewing 20 adverse event reports, the FDA issued a warning regarding SGLT2 inhibitors, including Invokana. The FDA determined that ketoacidosis can occur among those taking SGLT2 inhibitors such as Invokana.

Diabetic ketoacidosis is a very serious condition resulting from a lack of glucose to the body’s cells. When the cells don’t get the energy-producing glucose, they begin to burn fat for energy which in turn produces ketones. Ketones are chemicals created when the body breaks down fat for energy, and as ketones build up in the body, it becomes more acidic. Early warning signs of ketoacidosis include frequent urination, high blood glucose levels, dry mouth, excessive thirst, extreme fatigue, flushed skin, abdominal pain, nausea and vomiting, difficulty breathing and confusion.

How Invokana Works

Invokana is generally used in conjunction with diet and exercise and can also be used with other diabetic drugs such as metformin. Type II diabetes affects some 24 million people in the U.S. When left untreated, Type II diabetes can lead to cardiovascular issues, loss of vision, kidney damage and nerve damage. Invokana works as an inhibitor of sodium glucose co-transporter 2, blocking the reabsorption of glucose by the kidneys. Janssen conducted nine clinical trials with more than 10,000 patients prior to gaining FDA approval, and were required to conduct five more long-term studies, including one on cardiac issues related to Invokana, and others on pancreatic disease, cancer, liver and bone loss issues as related to Invokana.

FDA Adverse Event Reports

In addition to the current FDA warnings, there have been more concerns regarding Invokana, with more than 450 serious adverse event reports filed with the agency. Fifty-four of those reports were of kidney failure or impairment, fifty-four were for severe dehydration, eleven for the development of kidney stones, fifty cases of serious urinary tract infections and fifty-two cases of abnormal weight loss. Other than renal issues, there were fifty cases of allergic responses to Invokana.

Some question whether the benefits of Invokana outweigh the potential risks; prior to receiving FDA approval in 2013, those taking Invokana in clinical trials were found to have a higher risk of developing a fungal infection than others in the general population. Animal studies found that long-term exposure to Invokana could lead to bone abnormalities, kidney cancer, testicular cancer and long-term kidney disease.

Institute for Safe Medication Practices Report

At this time lawyers are accepting cases for those who have suffered harm after taking Invokana for their Type II diabetes. Invokana was developed by Mitsubishi Tanabe Pharma, marketed under license by Janssen, a division of Johnson & Johnson. The FDA warning came on the heels of a report by the Institute for Safe Medication Practices, which questioned whether the potential risks of Invokana outweigh the drug’s benefits. Invokana received FDA approval and was marketed in 2013—at the same time pancreatic cancer links were associated with the diabetic drugs Januvia, Janumet, Victoxza and Byetta.

Getting the Help You Need

Most cases, which involve dangerous drugs allege design, manufacturing or marketing defects as well as a company’s failure to warn of specific side effects. Patients who have experienced ketoacidosis, heart issues, stroke, pancreatic or liver disorders or other issues associated with Invokana should speak to a knowledgeable dangerous drug attorney who is familiar with the issues associated with Invokana.

At Golomb & Honik, our dangerous drug lawyers have considerable experience and success representing patients and families that have been injured by a negligent drug manufacturer. If you or someone you love has suffered injury after taking the dangerous drug Invokana, we can help. We believe in holding negligent pharmaceutical companies responsible for their actions and will fight aggressively for you and your family.

To learn more about your rights and legal options, call the Philadelphia defective drug lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

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