FDA tracks Invokana

Wednesday, Jul 12, 2017

Invokana, a diabetic medication and an SGLT2 inhibitor, was also in the news as the FDA now requires a serious boxed warning to be highlighted in the labels about the increased risk of leg and foot amputations. This decision is bagged by the results of two interim clinical trials and is applicable to all the canagliflozin drug labels. Previously, a safety warning about the increased risk of acute kidney injury and kidney failure, followed by a warning of increased risk of ketoacidosis was ordered by the FDA to be a part of the label. Invokana Multidistrict Litigations (MDLs) are filed before U.S. District Judge Brian Martinotti in the District of New Jersey. Cases have also come forward wherein Plaintiffs have further alleged that the use of Invokana resulted in increased risk of ischemic stroke along with Urosepsis which is a dangerous type of urinary tract infection. The number of litigations filed is expected to rise as more research results are brought forth.

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