December 2016 FDA Determination About Cardiovascular Benefits Also Includes Increased Drug Safety Warnings Label Change For Jardiance
(Posted by Tom Lamb at DrugInjuryWatch.com)
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, analyst with the Edward Jones investment company, expects annual Jardiance sales to approach $4 billion by the early 2020s, up from $200 million now, split with privately held German partner Boehringer Ingelheim.
Evans 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.
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From that new Jardiance drug label (accessed 12/12/2016), at "5 Warnings and Precautions", we get this updated safety information:
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.
Before initiating JARDIANCE, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications (diuretics, ACE inhibitors, ARBs, NSAIDs). Consider temporarily discontinuing JARDIANCE in any setting of reduced oral intake (such as acute illness or fasting) or fluid losses (such as gastrointestinal illness or excessive heat exposure); monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue JARDIANCE promptly and institute treatment.
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.
Finally, moving beyond the December 2016 label change for Jardiance, we point out this recent medical journal article, "A Case of Septic Shock Due to Serratia marcescens Pyelonephritis and Bacteremia in a Patient Receiving Empagliflozin", with an adverse drug reaction case report involving Jardiance. From that article, which was published in the Journal of Pharmacy Practice, we get this overview from the Abstract:
Sodium–glucose cotransporter 2 (SGLT2) inhibitors have been associated with serious urinary tract infections (UTIs) including pyelonephritis and urosepsis. The Food and Drug Administration (FDA) issued a label change to include this warning in December 2015 due to a small number of cases (n = 19) reported to the FDA Adverse Event Reporting System. Details of these cases are limited and none involved [Jardiance (empagliflozin)]. To date, there has been no published literature comprehensively describing serious UTIs attributed to [Jardiance (empagliflozin)]. We describe a case of septic shock due to Serratia marcescens pyelonephritis and bacteremia that required intensive care unit admission in a well-controlled, type 2 diabetic patient who had begun taking [Jardiance (empagliflozin)] 2 months prior. The patient was treated successfully with intravenous antibiotics followed by oral ciprofloxacin. After discontinuation of [Jardiance (empagliflozin)] and completion of antibiotic therapy, no subsequent UTIs were documented in the following 4 months.
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.
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