Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
While we have frequently discussed DKA, kidney damage, and amputations as possible side effects of diabetes drugs in the SGLT-2 inhibitors class -- such as Farxiga, Invokana, Jardiance -- strokes and thromboembolic events are also considered potential harmful effects of these drugs.
Based on FAERS reports received during the second quarter of 2015, posted in early 2016, the FDA identified both strokes and thromboembolic events as a "potential signal of a serious risk" for SGLT-2 inhibitors, and stated that they are "evaluating the need for regulatory action."
This warning applies to the following SGLT-2 inhibitors:
- Farxiga (dapagliflozin)
- Invokana (canagliflozin)
- Jardiance (empagliflozin)
- Glyxambi (empagliflozin/linagliptin)
- Invokamet (canagliflozin/metformin HCl)
- Synjardy (empagliflozin/metformin HCl)
- Xigduo XR (dapagliflozin/metformin HCl)
Though this information was provided back in January 2016, hardly any new information on these possible side effects has been provided.
The CANagliflozin cardioVascular Assessment Study (CANVAS) studied the effects of Invokana "compared to placebo on CV events including CV death, heart attack, and stroke in patients with T2DM." While this study has recently been completed, the actual study results have yet to be posted.
The Abstract of a recent article, titled "Impact of glucose-lowering therapies on risk of stroke in type 2 diabetes," provides the following information:
As for DPP-4 inhibitors, there was a non-significant trend towards benefit for stroke, whereas a possible increased risk of stroke with SGLT2 inhibitors—and in particular, [Jardiance (empagliflozin)] in the EMPA-REG OUTCOME trial—has been suggested and requires clarification...
In summary, the effects of antidiabetic drugs on risk of stroke appear to be heterogeneous, with some therapies (pioglitazone, GLP-1 receptor agonists) conferring possible protection against ischaemic stroke, other classes showing a neutral impact (DPP-4 inhibitors, insulin) and some glucose-lowering agents being associated with an increased risk of stroke (sulphonylureas, possibly SGLT2 inhibitors, high-dose insulin in the presence of insulin resistance).
Regardless of the studies that have been completed, the FDA does not appear to have made a definitive decision regarding the relationship between SGLT-2 inhibitors and strokes or thromboembolic events such as pulmonary embolism (PE) and deep vein thrombosis (DVT).
We will continue to monitor the medical literature and news concerning the FDA's determination regarding the SGLT-2 inhibitors class of diabetes drugs and the possible increased risk of stroke and thromboembolic events.
In the meantime, we invite you visit our website, and to submit a free case evaluation if you or someone you know has experienced one of the following side effects after using a brand-name SGLT-2 inhibitor (see earlier list):
- Acute Kidney Injury
- Kidney Failure or damage
- Diabetic Ketoacidosis (DKA)
- Ischemic Stroke / Cerebrovascular Accident (CVA)
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Leg Amputation
- Foot or Toe(s) Amputation
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