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Although a steady stream of serious health concerns have been linked to side effects of Invokana, Farxiga and similar drugs that are part of a new class of diabetes treatments in recent years, a new study suggests that the medications may be useful in cutting heart failure rates.
Researchers with AstraZeneca, the makers of Farxiga, presented data at the American College of Cardiology’s annual scientific session, indicating that the class of drugs known as sodium glucose cotransporter 2 (SGLT-2) inhibitors decreased the risk of death by 51% and the risk of hospitalization for heart failure by 39%. The findings have not yet been published for peer review.
“Diabetes is a growing epidemic worldwide, which is associated with significant comorbidities that contribute to an increased risk of costly hospitalisations and even death,” Dr. Bruce Cooper, Vice President and Head of Global Medical Affairs at AstraZeneca, said in a March 19 press release. “Real-world data from this study provide striking evidence that the newer SGLT-2i class of medicines cuts the rate of hospitalisations for heart failure and death by approximately half.”
The study, CVD-REAL, looked at data on more than 300,000 patients in six countries, involving data on the use of Invokana, Farxiga and Jardiance, which are each part of this new class of diabetes drugs, which work in a unique way by impacting the normal functioning of the kidney.
Since the drugs were introduced over the past few years, the drug makers have aggressively promoted the medications and encouraged doctors to switch diabetics to the new treatments. However, serious questions about the safety and benefits of the drugs have emerged, as a number of serious health concerns have been identified based on adverse event reports, leading to a number of warning label updates and concerns about whether the drug makers withheld information about the known risks associated with the medications.
In December 2015, the FDA required AstraZeneca, 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.
Less than a year later, in June 2016, the FDA required another warning label update to add information about the link between Invokana and kidney risks, indicating that the medication may increase the risk of acute kidney injury and other severe health problems. there have also been growing concerns of links to heart attacks.
A growing number of Invokana lawsuits, Farxiga lawsuits and other cases involving SGLT-2 drugs have been filed nationwide by plaintiffs who say the manufacturers failed to adequately warn the medical community about the drugs’ health risks.
Given similar questions of fact and law raised in lawsuits filed throughout the federal court system, the Invokana cases have been consolidated as part of an MDL (multidistrict litigation), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey for coordinated discovery and pretrial proceedings. However, if Invokana settlements or another resolution for the cases is not reached during the MDL process, the cases may later be remanded to U.S. District Courts nationwide for a separate trial dates.
Lawsuits against Farxiga and other similar diabetes drugs were not included in the Invokana MDL, but a separate motion to consolidate all Farxiga cases against AstraZeneca will be considered by the U.S. Judicial Panel on Multidistrict Litigation (JPML) later this month.