Diabetes drug gets FDA warning due to amputation risk

May 17, 2017

(HealthDay)—The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration says.

The FDA is requiring the medications to carry new warnings about the risk. The required warnings on the drug's labeling include the most serious and prominent boxed warning.

The agency's decision is based on data from two large clinical trials showing that leg and foot amputations occurred about twice as often in patients taking canagliflozin as among those taking a placebo.

Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred. Some patients had more than one amputation, some had amputations involving both limbs, according to the FDA.

Type 2 diabetes occurs when the body becomes resistant to insulin. Insulin is a hormone that helps to usher sugar from foods into the body's cells. When this process doesn't work correctly, blood sugar levels rise. Left untreated, levels can cause a number of possible complications, including heart disease, kidney problems and amputations, according to the American Diabetes Association.

Canagliflozin is meant to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs lower by causing the kidneys to remove sugar from the body through the urine.

It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

Patients taking canagliflozin should immediately notify their health care providers if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet, the FDA said in a news release. Patients should not stop taking their medication without first talking to their .

Before prescribing canagliflozin to patients, doctors should consider factors that may predispose patients to the need for amputations, including a history of prior amputation, , neuropathy, and , the FDA said.

In addition, doctors should monitor patients taking canagliflozin for the above signs and symptoms, and discontinue canagliflozin if these complications occur.

In a statement, Janssen Pharmaceuticals, the maker of canagliflozin, said the company had already shared the findings on amputation risk with medical professionals prior to this warning.

"While the incidence was low, the highest incidence of amputations across all treatments was seen in with prior ," Janssen said.
"At Janssen, patient safety is our highest priority. We are working with FDA to include this information in the prescribing information for canagliflozin."

Explore further: FDA issues warning for type 2 diabetes drugs

More information: The American Diabetes Association has more on diabetes complications.

Related Stories

FDA issues warning for type 2 diabetes drugs

May 18, 2015
(HealthDay)—A certain class of type 2 diabetes drugs can lead to a life-threatening condition called ketoacidosis, the U.S. Food and Drug Administration warns.

New oral diabetes drugs may also protect patients' kidney health

August 18, 2016
A recent study indicates that a new class of oral diabetes drugs may help protect patients' kidney health in addition to lowering their blood sugar levels. The findings appear in an upcoming issue of the Journal of the American ...

Low incidence of diabetic ketoacidosis with canagliflozin

July 29, 2015
(HealthDay)—For canagliflozin-treated patients with type 2 diabetes, the incidence of serious adverse events of diabetic ketoacidosis (DKA) is low, according to research published online July 22 in Diabetes Care.

Randomized trial will reveal diabetes drug's effects on kidney health

January 25, 2017
Type 2 diabetes often causes damaging effects to the kidneys, sometimes resulting in the need for dialysis or kidney transplantation. The ongoing CANVAS-R trial is testing whether canagliflozin—a member of a new class of ...

Effectiveness of canagliflozin in treating type 2 diabetes

July 6, 2016
Research led by the University of Dundee has found that one of a new breed of drugs, which have been approved for treatment of type 2 diabetes, may be particularly effective without the need to be used in combination with ...

Type 2 diabetes mellitus: Added benefit of canagliflozin is not proven

June 17, 2014
Canagliflozin (trade name: Invokana) has been approved since November 2013 as monotherapy and in various combination therapies for adults with type 2 diabetes mellitus when diet and exercise alone do not provide adequate ...

Recommended for you

Diagnosing diabetes from a single blood sample

June 18, 2018
Diagnosing type 2 diabetes in clinical practice may require only a single blood sample, according to a study led by researchers at Johns Hopkins Bloomberg School of Public Health.

Lentils significantly reduce blood glucose levels, study reveals

June 13, 2018
Replacing potatoes or rice with pulses can lower your blood glucose levels by more than 20 per cent, according to a first-ever University of Guelph study.

Is there a link between diabetes and Parkinson's disease?

June 13, 2018
People with type 2 diabetes may have an increased risk of having a diagnosis of Parkinson's disease later in life, according to a large study published in the June 13, 2018, online issue of Neurology, the medical journal ...

Double-checking diabetes medications may reduce re-hospitalizations

June 11, 2018
Clinicians may take upwards of 15 minutes to double-check a patient's medication list in an electronic health record system, but according to a new study, this reconciliation process may be well worth the time for diabetes ...

How a gene linked to obesity could provide new insights into diabetes

June 8, 2018
A gene previously linked with obesity has been found to affect how the body processes insulin, with potential implications for some forms of diabetes.

New hope from the 'seven year switch' in type 1 diabetes

June 8, 2018
New research has shown that the rapid decline in insulin production that causes Type 1 diabetes continues to fall over seven years and then stabilises.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.