Diabetes Drug Update – Invokana and Farxiga
November 27, 2017
In May 2015, the FDA issued a Safety Communication advising that certain Type 2 Diabetes drugs known as SGLT2 inhibitors (including Invokana and Farxiga) may result in a serious condition known as ketoacidosis.1
In December 2015, the FDA announced that after additional review, it was requiring that the label for Invokana and Farxiga be changed to warn of the risk of ketoacidosis.2 In its Safety Communication announcing the label change, the FDA advised that it had identified 73 cases of ketoacidosis in patients treated with SGLT2 inhibitors, including Invokana and Farxiga.3
In December 2016, all federally filed cases alleging ketoacidosis as a result of taking Invokana were consolidated by the Judicial Panel on Multidistrict Litigation. As a result, all federal Invokana cases are pending before Judge Brian R. Martinotti of the U.S. District Court for the District of New Jersey. Judge Martinotti appointed Robins Kaplan LLP® attorney Holly Dolejsi to be a member of the Plaintiffs’ Steering Committee in that litigation.
In March 2017, Ms. Dolejsi argued for the formation of a Farxiga MDL before a panel of seven federal judges. The cases were consolidated by the Judicial Panel on Multidistrict Litigation shortly thereafter, and the MDL is now before Judge Lorna G. Schofield of the U.S. District Court for the Southern District of New York. In August 2017, Judge Schofield appointed Ms. Dolejsi as co-lead counsel of that MDL. Over fifty cases are pending in the Farxiga MDL. Extensive documentation has been obtained from the Defendants, and depositions of corporate witnesses has begun. On November 20, 2017, the Magistrate Judge assigned to the MDL scheduled a pre-settlement conference.
In June 2017, the New England Journal of Medicine published a Letter to the Editor which described a large study aimed at determining whether there was an increased risk of ketoacidosis with SGLT2 inhibitor drugs.4 The study looked at over 50,000 patients who had been prescribed an SGLT2 inhibitor, and over 90,000 patients who had been prescribed a DPP4 inhibitor.5 The study concluded that “SGLT2 inhibitors were associated with approximately twice the risk of diabetic ketoacidosis as were DPP4 inhibitors.”6
We are actively litigating cases alleging an association between Farxiga, Invokana, and ketoacidosis. For a free case evaluation, please call 1.800.553.9910 (toll-free) or contact us online here. Our medical advisors are standing by.
4 Fralick et al. Risk of Diabetic Ketoacidosis after Initiation of an SGLT2 Inhibitor. N ENGL J MED 376;23 (June 2017).
In Conversation with Tara Sutton, Head of The Mass Tort Practice at Robins Kaplan
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