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While a large number of Invokana lawsuits continue to be filed on behalf of individuals nationwide who suffered diabetic ketoacidosis or kidney failure after using the new-generation diabetes drug, a complaint recently filed by a Kentucky man indicates that side effects of Invokana caused a heart attack.
Invokana (canagliflozin) is a controversial diabetes treatment introduced in March 2013, which has been linked to a steady stream of serious health risks, resulting in dozens of lawsuits filed nationwide against Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, alleging that the drug maker 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.
In a complaint (PDF) filed in the U.S. District Court for the Western District of Kentucky about a month ago, Rickie Woodward indicates that he suffered an Invokana-induced heart attack, which is believed to be one of the first cases filed involving this injury.
Woodward began using Invokana to improve glycemic control, and treat his type 2 diabetes. In July 2015, he suffered a heart attack, or myocardial infarction, which he alleges would not have occurred if he and his doctors had known about the risks associated with Invokana.
The complaint notes that Invokana heart attacks may be a potential complication caused by diabetic ketoacidosis, indicating that Woodward would not have consumed the drug or would have been monitored for potential side effects if the drug makers had provided warnings.
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.
The lawsuit filed by Woodward and other plaintiffs allege that the drug makers clearly knew about the link between Invokana and ketoacidosis well before these warnings, yet placed their desire for profits before consumers’ safety. If stronger warnings had been provided, plaintiffs claim that many individuals may have recognized the symptoms of diabetic ketoacidosis earlier, or avoided the injury altogether by using a different diabetes drug. However, Woodward may be the first to file for having suffered a heart attack as a result.
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.
Last month, 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.
In a follow up report released by the ISMP in late June, the group indicated that the steady stream of new risks and warnings that have been required for Invokana highlight that the short clinical trials used by the drug makers to obtain FDA approval were a weak basis.
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.