Did You Suffer Serious Diabetic Ketoacidosis as a Result of an SGLT-2 Drug?
There may be in excess of 1,000 patients who have taken an SGLT-2 inhibitor drug for their Type 2 diabetes, who then developed diabetic ketoacidosis, which can be extremely serious, even fatal. The specific drugs involved in these ketoacidosis cases include:
- Invokana by Janssen (a subsidiary of Johnson & Johnson)
- Invokamet by Janssen (a subsidiary of Johnson & Johnson)
- Farxiga by AstraZeneca
- Xigduo XR by AstraZeneca
- Glyxambia by Boehringer Ingelheim
- Jardiance by Boehringer Ingelheim
Invokana is the clear market leader among these drugs, with $278 million in revenues during the first quarter of 2015. Farxiga, the second SGLT-2 inhibitor drug to receive FDA approval, is being heavily advertised, and is expected to increase its revenues of $33 million in 2013 significantly during 2015.What is Ketoacidosis?
Diabetic ketoacidosis is a potentially fatal illness associated with Invokana and other SGLT-2 inhibitor drugs. Ketoacidosis can lead to severe dehydration, swelling of the brain, death of bowel tissue, heart attack, kidney failure, coma and death. The mechanism of the SGLT-2 drug is, that rather than working on insulin production via metabolizing excess insulin, sugar excretion through the urine is increased, preventing those sugars from being reabsorbed into the kidneys.
When the body is unable to produce sufficient insulin, it begins to use fat as an alternative fuel source, and high levels of blood acids (ketones) build up in the bloodstream. When a patient is experiencing vomiting for more than two hours, ketoacidosis can be life-threatening, developing over a very short time.
Early symptoms of diabetic ketoacidosis include high blood sugar levels, decreased alertness, rapid breathing, fruity-smelling breath, severe headache, muscle stiffness, stomach pains, nausea, frequent urination, excessive thirst and dry mouth. Diabetic ketoacidosis has historically occurred only in those with Type 1 diabetes, however doctors are seeing more and more cases of ketoacidosis among patients with Type 2 diabetes who are taking an SGLT-2 inhibitor drug.
Twenty cases of diabetic ketoacidosis were reported to the FDA via adverse event reports through June 2014. It is commonly believed that less than 10% of those who are injured by a drug or medical device file an adverse event report with the FDA. This means SGLT-2 inhibitor drugs could be responsible for more than 500 cases of ketoacidosis in little more than two years.What are the Other Dangers Associated with SGLT-2 Inhibitor Drugs?
In addition to diabetic ketoacidosis, SGLT-2 inhibitor drugs have been linked to serious cardiovascular events (heart attack, blood clot and stroke) and kidney failure. Invokana pre-market clinical trials revealed a 6.9 hazard ration for major cardiovascular events which translates into a 690 percent increased risk of such an event among those taking Invokana, vs. a placebo.
Janssen is conducting post-market clinical trials to further study this risk. In an Invokana clinical trial, it was found the drug increased serum creatinine and decreased eGFR, resulting in renal function abnormalities. The elderly are at a significantly higher risk for developing kidney failure or kidney damage when taking an SGLT-2 inhibitor drug.Has the FDA Issued a Warning Regarding SGLT-2 Inhibitor Drugs?
In May 2015, the FDA warned that Type 2 diabetic medications in the SGLT-2 inhibitor class could potentially cause diabetic ketoacidosis. At that time, the FDA stated it would continue to investigate potential safety issues associated with SGLT-2 inhibitor drugs.Did SGLT-2 Inhibitor Drug Manufacturers Promote the Drugs Off-Label?
SGLT-2 inhibitor drug manufacturers have promoted these drugs as aiding in weight loss, even though the drugs are not FDA approved for that purpose. Advertisements for the drugs, convey to patients and doctors alike that SGLT-2 inhibitor drugs have been found to be safe and effective for weight loss. Considering the very serious side effects now linked to the drugs, these advertisements may alter the risk-benefit calculations made by consumers and doctors.Did SGLT-2 Manufacturers Exhibit a Clear Failure to Warn?
Many wonder whether the manufacturers of these drugs have exhibited a blatant failure to warn regarding the potential serious risks of the drugs. When a manufacturer is aware of potential hazards associated with a drug, yet fails to state these dangers on the labeling which accompanies the drug, the manufacturer may be held liable for patient injury. Plaintiffs must prove the manufacturer was aware of the dangers, had a duty to warn consumers, and was negligent in that duty, resulting in injury to the consumer.Were You Injured by an SGLT-2 Inhibitor Drug?
If you suffered serious injury such as diabetic ketoacidosis, kidney failure or kidney damage, heart attack, stroke or blood clot after taking an SGLT-2 inhibitor drug, it could be extremely beneficial to speak to a knowledgeable attorney who can ensure your rights are fully protected.Contact Our Experienced Jackson Dangerous Drug Lawyers
If you have suffered serious diabetic ketoacidosis or injury because of an SGLT-2 drug, such as Invokana, you need an experienced Jackson Dangerous Drug lawyer on your side. At Coxwell & Associates, PLLC, our law firm has the skills and resources necessary to take on large pharmaceutical companies – and win. We will fight aggressively for you and your family. Contact Coxwell & Associates today at 1-601-948-1600 or 1-877-231-1600.