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Side effects of Invokana have been linked to reports of severe and potentially life threatening injuries, including kidney failure, amputations, heart attacks and dangerously high blood acid levels, known as ketoacidosis.
STATUS OF INVOKANA LAWSUITS: Product liability lawyers are reviewing whether users who experienced ketoacidosis, heart attacks, leg and foot amputations, or kidney failure may be entitled to financial compensation through an Invokana lawsuit.
MANUFACTURER: Johnson & Johnson
OVERVIEW: Invokana (canagliflozin) was the first in a new class of diabetes drugs, which work by altering normal kidney functions so that sugar is excreted through the urine. It was approved in March 2013 by the FDA, and has rapidly grown to become a blockbuster medication, generating an estimated $1 billion in annual sales.
The class of drugs, known as sodium-glucose costransporter-2 (SGLT2) inhibitors, also includes the new medications Farxiga, Glyxambi, Jardiance, and Xigduo XR. They are approved as a second-line drug to treat type 2 diabetes.
Since Invokana was introduced, it has been linked to hundreds of adverse event reports of kidney failure, kidney damage, amputations, and diabetic ketoacidosis, as well as urinary tract infections, hypersensitivity and weight loss.
Lawsuits allege that the drug makers failed to adequately warn consumers and the medical community about the potential risk of Invokana side effects.
INVOKANA AMPUTATION RISKS: In May 2017, the FDA issued yet another safety warning indicating that Invokana could increase the risk of leg and foot amputations.
The drug will carry a boxed warning about the amputation risks, which is the strongest label warning the FDA can require.
A study published in June 2017 in the New England Journal of Medicine again appeared to confirm the amputation risk, indicating that Invokana use increased the risk of leg and foot amputations by 97%.
Studies suggest the amputation risks are specific to Invokana and do not yet appear to apply to competing drugs, like Jardiance and Farxiga.
INVOKANA KETOACIDOSIS SIDE EFFECTS: On May 15, 2015, the FDA issued a drug safety communication, warning about the risk of ketoacidosis from Invokana and other diabetes drugs in the same class. In December, that warning was updated, warning patients to stop using the drug immediately at the first signs of ketoacidosis, and to seek medical attention. The FDA also added warnings of urinary tract infections that could be signs of serious blood infections or kidney failure.
Diabetic ketoacidosis involves a build of acid in the blood, which causes serious medical problems that usually require hospitalization or emergency room treatment. In severe cases, Invokana ketoacidosis problems could result in heart attack, death or debilitating long-term injury.
According to the FDA, between the launch of Invokana in March 2013 and June 6, 2014, the agency received at least 20 adverse event reports of users of SGLT2 inhibitors suffering ketoacidosis. These resulted in hospitalization or the need for emergency room visits in every case. The FDA reported that it has continued to receive adverse event reports of similar problems since that time, and the agency is investigating the potential side effects of Invokana and related diabetes treatments.
Symptoms of ketoacidosis from Invokana may result in:
- Difficulty Breathing
- Abdominal Pain
- Unusual Sleepiness or Fatigue
Patients who are taking Invokana and suffering these side effects should seek immediate medical attention, the FDA warned.
In a study published in November 2017, Invokana was linked to a higher rate of ketoacidosis injury adverse event reports than its competitors.
INVOKANA KIDNEY FAILURE RISK: Although Invokana works by inhibiting kidney function, and several experts have suggested that the drug makers knew or should have known about the risk of kidney problems from Invokana, potential failure to warn claims are being reviewed for individuals who have suffered kidney failure after using the type 2 diabetes drug.
According to a QuarterWatch report (PDF) issued by the Institute for Safe Medication Practices (ISMP) on May 6, Invokana side effects were linked to 457 reports of serious adverse events submitted to the FDA during the first year the drug was on the market. Since reported adverse events typically only represent a small portion of all problems associated with prescription medications, this suggests that thousands of individuals have experienced Invokana problems since the medication was introduced in March 2013.
Most of the reported adverse events involved Invokana kidney problems, including kidney failure, kidney impairment or problems with kidney stones. They also included urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Urofungal infections in both men and women were the most frequently reported side effect.
The ISMP has questioned whether the health risks with Invokana may outweigh the benefits provided for diabetics. The group reported that adverse event reports linked to side effects of Invokana were higher than 92% of all drugs ISMP regularly monitors, and the patients experiencing the problems were typically younger than many diabetics.
INVOKANA BONE FRACTURE RISK: In September 2015, the FDA issued a safety warning indicating that Invokana may increase the risk of bone fractures.
New bone fracture warnings will be added to the “Warning and Precaution” section of the drugs’ label, and revised information will be placed in the “Adverse Reactions” section as well, the agency announced.
FIND OUT IF YOU MAY QUALIFY FOR AN INVOKANA KETOACIDOSIS OR KIDNEY FAILURE LAWSUIT: As a result of the drug maker’s failure to adequately warn about the risks associated with their medication, Invokana injury lawyers are evaluating whether users may be entitled to compensation through a product liability lawsuit.
To request a free consultation and claim evaluation to determine whether you, a friend or family member may be entitled to financial compensation through a lawsuit, submit information about a potential Invokana lawsuit for review by a lawyer.