Invokana and Other New Diabetes Drugs Lead to Ketoacidosis (DKA), Cardiac Episodes, and Kidney Failure
In 2013, the Food and Drug Administration (FDA) approved Invokana, the first member of a new class of drugs used for treatment of Type 2 Diabetes. Called SGLT2 Inhibitors, these drugs are intended to be used in combination with diet and exercise to lower blood sugars in adults with type 2 diabetes. There are many problems associated with untreated type 2 diabetes such as neuropathy, kidney disease, high blood pressure, stroke, gastroparesis, heart disease, retinopathy, and other complications.
The drugs that make up the SGLT2 inhibitor class include:
{Brand Name Drug (Generic Name) - FDA Approval Date - Manufacturer}
- Invokana (Canagliflozin) - March 29, 2013 - Janssen Pharmaceuticals
- Farxiga (Dapagliflozin) - January 8, 2014 - Bristol-Meyers Squibb Company, and AstraZeneca Pharmaceuticals
- Jardiance (Empagliflozin) - August 1, 2014 - Boehringer Ingleheim Pharmaceuticals with Eli Lilly and Company
- Invokamet (Canagliflozin and Metformin) - August 8, 2014 - Janssen Pharmaceuticals
- Xigduo XR (Dapagliflozin and Metformin extended-release) - October 30, 2014 - Bristol-Meyers Squibb Company, and AstraZeneca Pharmaceuticals
- Glyxambi(Empagliflozin and Linagliptin) - February 2, 2015 - Boehringer Ingleheim Pharmaceuticals with Eli Lilly and Company
Invokana and the other SGLT2 Inhibitors were designed to assist in lowering blood sugars by working with your kidneys to expel sugar through urination. However, serious side effects have been linked to the use of these drugs, including cardiac events such as myocardial infarction (heart attack), kidney failure, and ketoacidosis.
Facts about Invokana and other SGLT2 Inhibitors:
- Despite only being FDA approved since March 2013, Invokana (along with its companion drug Invokamet) already makes up 4.9% of the market of non-insulin diabetes medications apart from metformin. In the first quarter of 2015, sales of Invokana hit $278 million, nearly triple the same period in 2014. With sales only expected to grow, Invokana is expected to hit $1 billion in sales in 2015.
- As early as January 2013, prior to Invokana’s approval, there were concerns over potential problems with Invokana. At the FDA approval hearing for Invokana in January 2013, testimony was given about a study being conducted by Janssen Pharmaceuticals called the CANVAS study in which it was observed that a user of Invokana was 6.49 times more likely to suffer a cardiac event within the first 30 days of use than a study participant who was prescribed a placebo.
- In May 2015 the FDA issued a warning that each of the drugs in the SGLT2 inhibitor class, Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance, and Glyxambi had been linked with ketoacidosis, or DKA. The FDA issued this warning after receiving 20 adverse event reports between March 2013 and June 6, 2014 of patients being treated with an SGLT2 inhibitor who required emergency room visits or hospitalization to treat ketoacidosis. The FDA said it had continued receiving additional adverse event reports for DKA and ketoacidosis since June 6, 2014, but did not give exact numbers. In many of these instances, the cases were not typical for DKA because the patients had type 2 diabetes (DKA is more common in persons with Type 1 diabetes) and also because their blood sugar levels were only slightly increased compared to typical cases of DKA, where the blood sugar levels are generally quite elevated.
- Also in May 2015, a report was issued by the Institute for Safe Medication Practices that noted in the first year after Invokana’s approval 457 serious adverse events were reported to the FDA with Invokana as the primary suspect drug, including 54 cases of kidney failure. The same FDA Invokana approval hearing in January 2013 included as an exhibit a memorandum on the safety of Invokana on kidney function. The memorandum noted that available data made it prudent to assume that Invokana “places patients at increased risk for clinically significant episodes of acute kidney injury.”
If you or a loved one has used or is using Invokana or another SGLT2 inhibitor and have suffered from kidney failure, diabetic ketoacidosis (DKA), or a cardiac event such as a heart attack, or you have lost a loved one for one of these reasons, find out how Johnson Becker, PLLC can help you. Please either call us at our toll free number, (800) 279-6386, or fill out our case review form here on our website and submit it for a free consultation.
