Black Box Warning Added to Invokana Diabetes Drug Label

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In a cardiovascular outcomes trial, Johnson & Johnson’s Invokana shows some improvement for some high-risk type 2 diabetes patients. Invokana (canagliflozin) compared to Eli Lilly and Boehringer Ingelheim’s Jardiance at cutting a composite measure of cardiovascular risks, showed a 14 percent reduction. This is the same number Jardiance had back in 2015, reports Fierce Pharma.

Unlike Jardiance, which did not make a significant difference in two instances, Invokana lowered the risk of heart attack by 15 percent, and stroke by 10 percent. Johnson & Johnson (J&J) is pleased with the Invokana data, revealed recently at the American Diabetes Association’s annual meeting.

Warning Update on Invokana Label

There will be a label update on the drug’s medication information. “We think looking at the data – the size, the breadth, the duration of the trials – we think these are very strong, very clinically important, and we look forward to filing this with FDA and other regulatory agencies around the world,” Jim List, Janssen’s global therapeutic head for cardiovascular and metabolism, said in an interview before the release. Janssen Pharmaceuticals is a J&J subsidiary.

However, a risk that accompanies Invokana, the sodium-glucose cotransporter 2 (SGLT2) inhibitor, is lower limb amputation. There is “about a twofold increase” in the rate of lower extremity amputations, List said. That risk first came to light in 2016 when it was revealed by an independent data monitoring committee, and since May of this year, Invokana will require new warnings.

The U.S. Food and Drug Administration (FDA) added a black box warning to Invokana’s label, the most serious level of warning to be placed on a label. As far as investigators currently know, within the SGLT2 class, lower limb amputation is a risk that is unique to Invokana, reports Fierce Pharma.

National law firm Parker Waichman LLP has extensive experience and success representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.

CANVAS Clinical Trials

The two clinical trials, the 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), revealed that leg and foot amputations occurred about twice as frequently in patients treated with canagliflozin compared to patients treated with a placebo. Most common were amputations of the toe and middle of the foot, but amputations involving the leg, below and above the knee, also took place. In some cases, according to the FDA, more than one amputation was required.

Diabetes Drugs Increase Risk of Amputation

Test results showed that 5.9 out of every 1,000 patients treated with canagliflozin underwent some amputation, compared to 2.8 out of every 1,000 patients treated with placebo who also experienced amputation. Of the patients who underwent amputations, 99 out of 140 receiving canagliflozin had their mid-foot or a toe removed, while amputations involving the leg and the knee accounted for 41 out of 140 amputations. Some patients underwent more than one amputation, reports Pulse Headlines.

Now regulators say doctors should “consider factors that may predispose patients to the need for amputations,” such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, before prescribing Invokana, FiercePharma reports.

Type 2 diabetes, if left untreated, can lead to kidney damage, heart disease, and blindness. Physicians should inform patients how canagliflozin is linked to an increased risk of amputation. The European Medicines Agency advised in a statement in February, “Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine preventative foot care. They should also tell their doctor if they notice any wounds or discoloration, or if their feet are tender or painful.”

Canagliflozin Side Effects

Benefits must be weighed against risks as all medications have side effects. Caniglaflozin can cause hypotension, ketoacidosis (too much acid in the blood), kidney problems, a large amount of potassium in the blood, urinary infections, high cholesterol, yeast infections, bone fractures, and low blood sugar, if combined with other drugs taken for treating diabetes.

FDA Warnings Concerning Invokana

The FDA approved Invokana in 2014. In patients with diabetes, the body is unable to properly break down sugar for energy. When sugar cannot be utilized, the body resorts instead to fat for energy. Tests show that patients taking Invokana are more likely to suffer from diabetic ketoacidosis (DKA) Signs of ketoacidosis are frequent urination, excessive thirst, nausea and vomiting, abdominal pain, shortness of breath, fruity-scented breath, and confusion, according to the Mayo Clinic.

Legal Help Regarding Diabetes Medications’ Side Effects

If you or someone you know has been injured by Invokana or other diabetes medications, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman


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