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According to allegations raised in a recently filed product liability lawsuit, side effects of Invokana caused a woman to suffer a stroke, kidney damage, diabetic ketoacidosis and other injuries.
The complaint (PDF) was filed by Judy Thompson in the U.S. District Court for the District of New Jersey on June 1, naming Johnson & Johnson, it’s Janssen Pharmaceuticals subsidiary and Mitsubishi Tanabe Pharma Corp. as defendants.
Thompson states that she began taking Invokana in February 2015, and continued to use the new-generation diabetes drug until June 2015. The lawsuit indicates that the medication caused her to suffer a number of severe and permanent injuries, alleging that the drug makers failed to adequately warn consumers and the medical community about the potential risks.
“The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentation concerning the nature and safety of Invokana,” the complaint states. “This conduct, as well as the product defects complained of herein, were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”
Thompson’s case joins a growing number of Invokana lawsuits filed in recent months over problems associated with the diabetes drug, which has only been on the market for three years. The complaints indicate that the drug makers placed their desire for profits before consumers safety by failing to adequately research the medication before it was introduced and aggressively marketed as a superior diabetes treatment.
Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Amid aggressive marketing by the drug maker following approval, the medication was quickly adopted by the medical community, but a steady stream of potential safety risks with Invokana have emerged over the past few years.
Only two years after the drug was introduced in the United States, the FDA launched an investigation into a link between Invokana and ketoacidosis in May 2015, after identifying at least 20 reports of individuals being hospitalized due to acid problems with the drug or other members of the SGLT2 inhibitor class of diabetes medications.
Following a safety review, the FDA ultimately required Johnson & Johnson to add new Invokana warnings about ketoacidosis in December 2015, 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 September 2015, the FDA required new Invokana bone fracture warnings, indicating that the drug may also lead to decreased bone density.
A detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, which was conducted by the Institute of Safe Medication Practices (ISMP), identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors.
Earlier this month the FDA released a new Invokana safety warning, indicating that it may increase the risk of leg, foot, and toe amputations. However, the investigation into those potential side effects are ongoing.
Invokana and other members of this new-generation diabetes treatments work in a unique way, by impacting the normal function of the kidneys. However, investigators identified reports of kidney failure and other problems that they suspected were caused by the medication. Other members of the SGLT2 inhibitor class of diabetes drugs include Invokamet, Farxiga, Xigduo, Jardiance and Glyxambi.