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According to allegations raised in a product liability lawsuit filed last week, side effects of Invokana caused a Kentucky woman to suffer a heart attack, stroke, kidney failure and ketoacidosis after switching to the new-generation diabetes drug.
The complaint (PDF) was filed by Evelyn Johnston in the U.S. District Court for the District of New Jersey on September 2, naming Johnson & Johnson, it’s Janssen Pharmaceuticals subsidiary, and Mitsubishi Tanabe Pharma Corp. as defendants.
Invokana (canagliflozin) is a controversial diabetes treatment introduced in March 2013, which has been aggressively marketed as a new type of drug that works in a unique way from other diabetes treatments. However, as more individuals have been switched to the new drug, a steady stream of serious health risks have been uncovered, resulting in dozens of Invokana lawsuits alleging that the drug makers failed to adequately research the medication or warn about side effects.
Most of the cases filed involve individuals who suffered diabetic ketoacidosis from Invokana, which is a serious medical emergency caused by a build up of acid levels in the blood. There are also a number of Invokana kidney failure lawsuits filed on behalf of individuals diagnosed with renal failure or other kidney problems.
Johnston’s claim indicates she suffered both, as well as a heart attack and stroke. Allegations that individuals suffered a heart attack from Invokana have been associated with an emerging group of cases in the litigation.
According to the lawsuit, Johnston was first prescribed Invokana in May 2014. The ketoacidosis, stroke, heart attack and kidney failure she suffered while taking the drug led to life-threatening complications and multiple hospital stays.
Invokana was the first member of a new class of diabetes drugs introduced in recent years, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work in a unique way from other diabetes treatments. Other members of this class include Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
Amid aggressive marketing and promotion by the drug makers, Invokana quickly became a popular and widely used medication. However, as more and more individuals began to use the drug, the FDA has required the drug maker to add a number of new warnings.
In December 2015, the FDA required Johnson & Johnson and the makers of other SGLT2 inhibitors to add new diabetic ketoacidosis warnings to their medications, urging users to stop taking the drug and seek immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In addition to concerns about ketacidosis, a number of lawsuits filed against the drug maker alleging that the drug makers knew or should have suspected that Invokana increases the risk of kidney failure.
In May 2015, the Institute for Safe Medication Practices (ISMP) conducted a detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, and identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors, raising questions about whether the benefits provided by the medication justify the risk.
In June, the FDA released a new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
“Defendants had a duty to warn Plaintiff’s prescribing physicians about the risks of Invokana use, including the risk of diabetic ketoacidosis and resulting complications,” the lawsuit states. “Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings.”
As Invokana injury lawyers continue to review and file claims for individuals nationwide, it is widely expected that hundreds, if not thousands, of additional lawsuits may be filed in the coming months and years. Similar Invokamet lawsuits, Farxiga lawsuits, Xigduo lawsuits, Jardiance lawsuits and Glyxambi lawsuits are also being reviewed against the makers of these other SGLT2 inhibitors, which have been linked to similar health risks.