FDA: Canagliflozin (Invokana, Invokamet) Must Add Amputation Risk Warning


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By: Marilyn McGoldrick, Esq.

Published on May 16, 2017

The FDA has added a boxed warning to the label of  diabetes drugs containing canagliflozin (Johnson & Johnson’s brand names Invokana and Invokamet) to warn that these drugs carry an elevated risk of leg and foot amputations.

FDA Confirms Doubled Risk of Lower Limb Amputation When Taking Canagliflozin Drugs

Today’s FDA Drug Safety Communication confirms the approximately doubled risk of  lower limb amputations for patients taking Invokana (canagliflozin) or Invokamet (canagliflozin with metformin). The warning is based on new data from two large clinical trials. CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) showed about double the rate of amputations from diabetes patients on canagliflozin drugs, as compared to patients taking a placebo. Amputations mostly affect the toes and the middle of the foot. Amputations of the leg, below and above the knee, and to both limbs were also observed.

Europe Requires Amputation Warning on All SGLT2 Inhibitor Drugs, Not Just Canagliflozin

Invokana and Invokamet are classified as sodium glucose cotransporter-2 (SGLT2) inhibitor drugs. SGLT2s trigger the kidneys to release blood glucose into the urine, thereby lowering blood sugar levels.  The European Medicines Agency issued a requirement in February of 2017 that the labels of every drug in the SGLT2 inhibitor class carry the amputation warning.  The other drugs included as well as canagliflozin (brand names Invokana, Invokamet) are dapagliflozin (brand names Farxiga, Xigduo XR) and empagliflozin (brand names Jardiance, Glyxambi, Synjardy).

FDA Recommendations for Diabetes Patients and Their Health Care Providers When Using Canagliflozin

The FDA issued the following recommendations to patients, and to health care providers:

Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.

Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.

Reporting Adverse Events While Taking Invokana and Invokamet

The FDA encourages patients health care professionals and patients to report adverse events or side effects related to the use of canagliflozin and other medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. You can do this   by calling  800-332-1088 to request a reporting form; by using their online reporting form; by downloading an online form and submitting by mail, or by faxing the form to 1-800-FDA-0178.

What Can You Do?

If you have taken the canagliflozin-containing diabetes drugs Invokana or Invokamet, or any other SGLT2 inhibitor drug, and suffered an amputation, you may have a claim for damages. Contact the defective drug attorneys at Thornton Law Firm for a free, thorough evaluation of your legal rights at 1-888-341-1405. Or tell us your story using our online contact form. Like all lawsuits, Invokana claims must be filed within short time limits. Seek legal advice as soon as possible to protect your rights.

Invokana Cases Consolidated in MDL

Call 888-341-1405 for a free consultation with a recognized leader in personal injury and pharmaceutical drug litigation. You can also contact us online to discuss the details of your case.

By: Marilyn McGoldrick, Esq.

The Judicial Panel for Multidistrict Litigation has transferred all existing Invokana (canagliflozin) and Invokamet (canagliflozin/metformin) cases alleging ketoacidosis, kidney disease and other serious injuries filed in federal courts to the United States District Court for the District of New Jersey on December 7, 2016. If you have been injured by taking Invokana or Invokamet, there is still time to file a claim.

A total of 55 cases alleging injuries from these diabetes drugs were transferred to a consolidated docket known as an MDL before the Honorable Brian R. Martinotti. An MDL (stands for MultiDistrict Litigation) is created to efficiently handle similar complex cases. In an MDL, while the cases share common legal and factual issues, each case is still resolved individually.

Invokana and Invokamet are classified as sodium-glucose-cotransporter-2 drugs (a/k/a SGLT2 inhibitors).  SGLT2s work by  preventing the kidneys from reabsorbing blood sugar. This lets the sugar leave the body through the urine, thereby lowering blood glucose levels. SGLT2s are prescribed for Type 2 diabetes.

Invokana, manufactured by Johnson & Johnson and marketed in the U.S. by J&J subsidiary Janssen Pharmaceuticals, was the first SGLT2 approved by the FDA.  Invokana went on the market on March 29, 2013; Invokamet was not approved until August 8, 2014. Between March 2013 and October 2015, the FDA received reports of 101 cases of acute kidney injury, including kidney impairment or failure; kidney stones, dehydration; urinary tract infections, weight loss, hypotension (low blood pressure) and hypersensitivity.

In May 2015 the FDA warned that patients should be alert to the symptoms of too much acid in the blood (ketoacidosis), and seek medical attention immediately if “difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness”  is experienced while taking SGLT2s. The FDA had received 20 complaints from March 2013 to June 2014 of ketoacidosis, diabetic ketoacidosis, or ketosis in patients taking SGLT2s.

In June of 2016 the FDA strengthened the existing warning on Invokana and Invokamet to include information about acute kidney injury, adding recommendations to minimize the risk of such injury. This stronger warning also included the SGLT2s Farxiga and Xigduo XR.

However, in consolidating the Invokana and Invokamet cases in New Jersey, the Panel decided against consolidating any other SGLT2 drugs in the MDL. Instead, the court chose to consolidate only the canagliflozan drugs, finding:

“…the Invokana/Invokamet actions involve common questions of fact, and [] centralization of these cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. The actions share factual questions arising from allegations that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage. The actions thus implicate numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.”

If you have taken Invokana, Invokamet, or another SGLT2 diabetes drug and have experienced side effects, you should call your doctor immediately for diagnosis and treatment. If you have been diagnosed with ketoacidosis or any other serious side effect after taking Invokana, Invokamet, or any SGLT2, you may have a claim for damages. Call Attorney Marilyn McGoldrick at our toll free number 888-341-1405 or tell us your story here for a free, no obligation case evaluation.

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