Ketoacidosis is a life-threatening side effect of Invokamet in which the blood becomes too acidic due to toxins called ketones. Lawsuits have already been filed by people who developed this side effect.
Need a Texas Invokamet Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with ketoacidosis, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Invokamet contains canagliflozin, a diabetes medication in the SGLT2 inhibitor class. It lowers blood-sugar by forcing the kidneys to remove sugar from the body through urine.
What is the problem?
In December 2015, the FDA ordered drug-makers to update the Warnings & Precautions for Invokamet to include diabetic ketoacidosis — a life-threatening disorder in which the blood becomes too acidic due to toxins called ketones.
The Prescribing Information (PDF) for Invokamet also includes a “Black Box” warning about lactic acidosis, another condition in which the body is poisoned by acids in the bloodstream.
How Many Cases Have Been Reported?
The FDA received 73 reports of ketoacidosis between March 2013 and May 2015. However, the number of reports has increased substantially since the FDA began issuing warnings. Over 150 cases of acidosis have been linked to canagliflozin, according to a report by the Institute for Safe Medication Practices (ISMP).
Just days after the FDA warning in December 2015, the first lawsuits (PDF) were filed by people who used canagliflozin (sold alone under the brand-name Invokana) and developed ketoacidosis. The lawsuits accuse Janssen Pharmaceuticals of negligence:
- Manufacturing a dangerous medication
- Failing to adequately warn about the risk of ketoacidosis
- Using illegal methods to market it “off-label”
- Concealed knowledge about the risks
What is Ketoacidosis?
Diabetic ketoacidosis (DKA), also known as metabolic acidosis, is a metabolic disorder that occurs when the body does not have enough insulin to use blood-sugar for energy. This forces the body to burn fat for energy, which releases fatty-acids that are converted into toxins called ketones by the liver.
Symptoms of Ketoacidosis
As ketone levels increase, the blood and body fluids become more acidic. People with diabetes can check ketone levels with urine test strips. Elevated ketone levels (with or without elevated blood-sugar levels) are a symptom of ketoacidosis.
According to the FDA, patients should stop taking Invokamet and seek medical attention immediately if they have any symptoms of ketoacidosis, such as:
- Abdominal pain
- Trouble breathing
Treatment for Ketoacidosis
Ketoacidosis can develop within 24 hours. Without treatment, it can become life-threatening. Most people must be hospitalized or receive intensive care in the emergency room. They are usually given intravenous (IV) fluids, insulin to correct blood-sugar levels, and minerals to correct electrolyte imbalances (especially potassium). Most people go home from the hospital within a day or two.
Need an Invokamet Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Invokamet lawyers for a free lawsuit review.