Articles Tagged with Invokana

Invokana is a new class of Type 2 diabetes drug called sodium-glucose co-transporter 2 (SGLT2). This class of Type 2 diabetes drugs work by stopping glucose from being reabsorbed into the blood. The FDA approved Invokana in 2013 and has grown to over 2.7 million prescriptions per year.

In May 2015 the FDA release a statement warning doctors and patients that SGLT2 drugs may lead to DKA. If DKA is left untreated, it can be fatal.

In December 2015, the FDA ordered manufacturers of SGLT2 inhibitors to add warnings regarding the risk of urinary tract infection and ketoacidosis to the drugs’ labels.

The Food and Drug Administration (FDA) issued a drug safety communication stating that it has revised the warning labels of SGLT2 inhibitors, including Invokana, to include information about acute kidney injury.

According to a press release from the FDA, between March 2013 and October 2015, the agency received reports of 101 confirmed cases of acute kidney injury, some of which required dialysis and hospitalization, related to Invokana/Invokamet (canagliflozin, Janssen Pharmaceuticals) and Farxiga/Xigduo XR (dapagliflozin, Bristol-Myers Squibb/AstraZeneca).

The communication advised health care professionals to “consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin.” These include lower blood volume; chronic kidney insufficiency; congestive heart failure; and taking medications such as diuretics, ACE inhibitors, angiotensin receptor blockers and nonsteroidal anti-inflammatory drugs.

Invokana is a new class of Type 2 diabetes drug called sodium-glucose co-transporter 2 (SGLT2). This class of Type 2 diabetes drugs work by stopping glucose from being reabsorbed into the blood. The FDA approved Invokana in 2013. In May 2015 the FDA release a statement warning doctors and patients that SGLT2 drugs may lead to DKA. If DKA is left untreated, it can be fatal.

In December 2015, the FDA ordered manufacturers of SGLT2 inhibitors to add warnings regarding the risk of urinary tract infection and ketoacidosis to the drugs’ labels.

Diabetic ketoacidosis occurs when the body does not have enough insulin to manage glucose levels. During diabetic ketoacidosis the body starts developing a waste product known as acidic ketone bodies by burning fatty acids. Ketones are what cause symptoms of ketoacidosis. These symptoms include abdominal pain, fatigue, confusion, vomiting, and dehydration. In some rare cases, ketoacidosis can cause coma or death.

Two years after the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s Invokana, the FDA issued a drug safety communication that warned doctors and patients that Invokana may lead to diabetic ketoacidosis (DKA).

Invokana is a new class of Type 2 diabetes drug called sodium-glucose co-transporter 2 (SGLT2). This class of Type 2 diabetes drugs work by stopping glucose from being reabsorbed into the blood. The FDA approved Invokana in 2013. In May 2015 the FDA release a statement warning doctors and patients that SGLT2 drugs may lead to DKA. If DKA is left untreated, it can be fatal.

In December 2015, the FDA ordered manufacturers of SGLT2 inhibitors to add warnings regarding the risk of urinary tract infection and ketoacidosis to the drugs’ labels.