Breaking News: After two large clinical trials, the FDA concluded that the type 2 diabetes drug canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.
Diabetes is a serious illness that, for many patients, requires frequent life-long medication. But you don’t expect a drug prescribed to protect you from a disease to harm you as severely as canagliflozin, known by trade names Invokana, Invokamet and Invokamet XR.
Invokana belongs to a class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
If you or someone that you know have been affected by the side of effects of Invokana, contact our firm today to get free case evaluation.
The results of two clinical trials prompted the Food and Drug Administration to require manufacturer Janssen Pharms to add new warnings about the risk of canagliflozin to the medicines’ labels, including the most prominent of the FDA, known as the boxed warning.
The issues were officially introduced to the product’s labeling, according to a July 2017 update by the FDA. Previously, the FDA had issued a previous drug safety communication (May 2016) after interim clinical trial results showed an increased risk of amputations in patients taking Invokana and Invokamet.
Greg Jones Law has sued many major drug manufacturers for failing to warn of the dangers of their drugs. To find out if you have a case against the makers of Invokana, contact us today for a free case evaluation.
Leg and foot amputations occurred about twice as often in patients treated with Invokana, Invokamet and Invokamet XR in the two clinical trials. Toe and middle of the foot were the most common.
Amputations of the leg, below and above the knee, also occurred and some patients had more than one surgical intervention. There were cases of patients losing both legs.
The Canagliflozin Cardiovascular Assessment Study (CANVAS) showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to 5.9 out of every 1,000 patients treated with canagliflozin. This result is more than twice the 2.8 out of every 1,000 patients treated with a placebo.
In the other trial, A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R), the risk of amputation for patients over a year’s time were equivalent to 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 with placebo.
Severe ketoacidosis (DKA) could be a life-threatening side effect of Invokana medicines for type 2 diabetes patients, in addition to limb amputations and kidney problems.
Ketoacidosis is a very serious condition for the diabetic patient in which the body produces high levels of blood acids called ketones. If not handled immediately, it could lead to coma or death.
Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any of the above symptoms of ketoacidosis, as warned in December 2015 FDA safety announcement listing very serious risks and illness linked to these kind of drugs.
Ketoacidosis associated with this medicine can occur even if your blood sugar level is not very high, according to the FDA.
Invokana or canagliflozin, approved by the FDA in 2013 and made by Janssen Pharmaceuticals, Inc., is one of a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors approved to use – along with diet and exercise – to lower blood sugar in adults with type 2 diabetes.
Canagliflozin is available as a single-ingredient product under the brand name Invokana. In combination with diabetes medicine metformin HCI extended release tablets, is sold under brand names Invokamet and Invokamet XR.
The medicine lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.
Greg Jones Law is currently taking cases against the makers of diabetes drugs. If you or a loved one has experienced a life changing side effect of Invokana, Invokamet and Invokamet XR, like ketoacidosis or amputation, contact us today for a free case evaluation.
If you have been harmed or is suffering from taking your diabetes medication, it is important to understand your rights and options. You can have the experience of a national personal injury law firm on your side, especially Greg Jones Law, who has the means to represent clients throughout the United States in pharmaceutical litigation.
To find out if you have a case against the makers of Invokana or Invokamet contact us today for a free case evaluation. Call 855-566-3752 or contact us online.
What is Invokana? Information on Invokana warnings & a diabetes drug lawsuit:
Everything you need to know about Invokana side effects.
Learn more about the CANVA study that exposed amputations as a side effect of Invokana.
Our pharmaceutical attorney gives advice on an Invokana amputation lawsuit.
The details behind why people choose an Onglyza lawsuit.