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December 2016: FDA Requires Safety Warnings Label Change For Jardiance

After the December 2, 2016 decision by the FDA to expand the health benefits for the relatively new diabetes medicine Jardiance (empagliflozin) to include preventing fatal heart attacks and strokes in type 2 diabetes patients, we saw news reports about its expected effect on Jardiance sales in the U.S.

From this December 9, 2016 Reuters article, “New diabetes guidelines imminent, Jardiance sales may surge”, we get this information:

Two leading U.S. medical societies are poised in the coming weeks to issue new diabetes treatment guidelines reflecting the lifesaving cardiovascular effects of Eli Lilly’s Jardiance in a move expected to drive up the drug’s sales.

The forthcoming guidelines from the American Diabetes Association and the American Association of Clinical Endocrinologists….

[Ashtyn Evans, an analyst with the Edward Jones investment company,] predicted that doctors would now favor Jardiance for new patients over other similar drugs called SGLT-2 inhibitors, including Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga, until they complete their own heart-protection studies in the next two years.

What did not get this same type of media coverage was the other part of the FDA’s December determination, a “Revised: December 2016” Jardiance Prescribing Information document — also called the package insert or drug label — which contains increased warnings about some serious side effects.

From that new Jardiance drug label (accessed 12/12/2016), at “5 Warnings and Precautions”, we get this updated safety information:

5.2 Ketoacidosis

Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE.

5.3 Acute Kidney Injury and Impairment in Renal Function

JARDIANCE causes intravascular volume contraction and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors, including JARDIANCE; some reports involved patients younger than 65 years of age.

We point out that similar drug safety information was added back in August 2016 to the drug label for Invokana (canagliflozin), another diabetes medicine in the SGLT-2 inhibitors class of drugs.

Of course, we will continue to watch for reports of Jardiance adverse drug reactions (ADRs) made to the FDA or included in future medical journal articles.

[Read this article in full at original source]

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Invokana / Farxiga / Jardiance

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