Side Effects of Invokana Linked To Amputations, Other Problems
Concerns about a number of serious side effects have been linked to Invokana and other new-generation diabetes drugs, amid reports of kidney failure, leg and foot amputations, heart attacks, strokes and dangerously high blood acid levels, known as diabetic ketoacidosis.
Invokana (canagliflozin) is an oral medication for treatment of type 2 diabetes, which is part of a new class of drugs that work by inhibiting the normal function of the kidney to lower blood sugar in patients. Other members of this same class, which have been linked to similar side effects, including Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
Although these drugs were introduced as safe and effective diabetes treatments, adverse event reports suggest that the drug makers may have failed to adequately research their medication or warn about the potential side effects of Invokana.
Potential for product liability lawsuits have been reviewed by the lawyers at Saiontz & Kirk, P.A. for individuals who have experienced:
- Leg and Foot Amputations
- Diabetic Ketoacidosis (DKA)
- Renal or Kidney Failure
- Kidney Transplant Surgery
- Heart Attack
- Wrongful Death
At this time, cases involving ketoacidosis, kidney failure, heart attacks and strokes are no longer being accepted. However, the Invokana injury lawyers at Saiontz & Kirk, P.A. do provide free case evaluations for individuals throughout the United States who may have suffered amputation problems caused by the diabetes drug. Request a free consultation and claim evaluation.
Invokana Foot and Leg Amputation Side Effects
As more diabetics were switched to the new-generation treatment, concerns have emerged involving an increased risk of Invokana amputations, which appear to be unique to users of this specific SGLT2 Inhibitor, as the same problems were not seen with users of Farxiga and other competing treatments.
Foot and leg amputation problems with Invokana became increasingly apparent as doctors and patients submitted adverse event reports, and after interim results from an on-going clinical trial were released, known as CANVAS.
In May 2016, the FDA first issued an Invokana and Invokamet amputation warning, indicating that the agency was reviewing this new safety issue after identifying a large number of amputations, mostly affecting the toes.
For the first time, information was provided to users and doctors about the potential link between Invokana and amputations, highlighting the importance of monitoring for signs of problems, including:
- Pain in the Feet or Legs
- Leg or Foot Sores and Ulcers
- Infections involving the Foot or Leg
In May 2017, the FDA announced that new label information about the Invokana amputation side effects would be placed prominently in a “black box”, which is the strongest warning that can be required for a prescription medication.
The agency determined that nearly 6 out of every 1,000 patients that take Invokana or Invokamet may require an amputation, which is double the risk seen among diabetics given a placebo.
A study published by the New England Journal of Medicine in June 2017 appears to confirm these findings. Although researchers are still investigating the mechanism of the drug that increases the number of leg and foot amputations, doctors were urged to exercise caution and care.
Invokana Ketoacidosis Risk
In mid-2015, the FDA issued a drug safety communication to announce that it was investigating the link between Invokana and ketoacidosis. This warning came only two years after the medication was introduced, ultimately resulting in a requirement that the drug maker update the warning label after thousands of individuals had already experienced problems from this side effect.
Invokana ketoacidosis problems often result in the need for hospitalization and could lead to death in serious cases. While it is usually rare among individuals with type 2 diabetes, which Invokana is designed to treat, a number of FDA adverse event reports have been received involving users of Invokana diagnosed with ketoacidosis.
In December 2015, the agency indicated that new ketoacidosis warnings were being required for the entire class of diabetes drugs, advising patients to stop using the drug immediately and seek medical assistance if they began experiencing signs of ketoacidosis, such as:
- Breathing Difficulty or Respiratory Problems
- Nausea, Vomiting or Abdominal Pain
- Confusion, Fatigue or Sleepiness
Between March 2013 and May 2015, the FDA identified dozens of cases involving acidosis diagnosed as diabetic ketoacidosis, ketoacidosis or ketosis among patients treated with Invokana or other drugs in the same class.
Each of the ketoacidosis cases on Invokana or another SGLT2 inhibitor diabetes drug resulted in the need for emergency room treatment or hospitalization.
Invokana Kidney Failure Problems
During the first two years the new diabetes drug was on the market in the United States, there were also an alarming number of reports involving problems that may be caused by potential Invokana kidney side effects.
According to a report (PDF) released by the Institute for Safe Medication Practices (ISMP) in May 2015, Invokana problems were reported involving at least 457 patients during the first year the drug was on the market, including at least five different categories of kidney toxicity, including:
- Kidney Failure or Renal Impairment
- Dehydration and Fluid Imbalances
- Kidney Stones
- Urinary Tract Infections
- Abdnormal Weight Loss
In December 2015, the FDA required the makers of SGLT2 inhibitors to add new warnings about the potential risk of urinary tract infections, as this could be an indication of a more dangerous blood or kidney infection that could lead to kidney failure and even death.
Information about the Invokana kidney risks was strengthened in June 2016, when the FDA issued another drug safety communication about the importance of monitoring for symptoms of acute kidney injury, which is a side effect where the renal function is abruptly interrupted.
Since Invokana works by blocking kidney function, causing substantial amounts of sugar to be excreted through urine, many experts have suggested that the link between Invokana and renal failure should have been known or suspected before it was ever introduced. However, it appears that inadequate warnings were provided for consumers or the medical community about the risk of Invokana kidney side effects.
Invokana Failure to Warn Lawsuits
Since putting Invokana on the market, Johnson & Johnson has aggressively marketed the new diabetes treatment, attempting to capitalize on the “first-to-market” status among this new class of drugs. In addition, the drug was introduced amid mounting safety concerns over several other popular diabetes drugs, including Actos, Byetta, Januvia, Janumet, Onglyza, Victoza and Avandia.
While failing to adequately warn consumers and the public about the potential Invokana side effects, Johnson & Johnson was able to quickly grow their new diabetes treatment into blockbuster medication, with more than $278 million in sales during the first quarter of 2015 alone.
Some experts have suggested that the potential Invokana risks may outweigh the minimal benefits provided in treating type 2 diabetes. As a result, the lawyers at Saiontz & Kirk, P.A. believe the FDA should strongly consider issuing an Invokana recall. At a minimum, the drug makers should have provided stronger warnings earlier, so that consumers and doctors could make an informed decision about whether to use Invokana.
Potential Invokana failure to warn lawsuits are being reviewed by our law firm for individuals throughout the United States who suffered an amputation injury. New cases for ketoacidosis, kidney failure and other side effects of Invokana are no longer being accepted.