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Invokana 112 articles

J&J agrees to settle many Invokana side effects lawsuits

Johnson & Johnson has agreed to pay an undisclosed amount to settle a large number of lawsuits pending in a multidistrict litigation in New Jersey accusing the company’s diabetes drug Invokana of causing kidney failure, diabetic ketoacidosis or amputations, according to the New Jersey Law Journal. A settlement fund is expected to be ruled on by Nov. 19. It’s unclear how many of the more than 1,000 cases are included in the settlement, but attorneys say more settlements are likely. Bellwethers from the multidistrict litigation were set to go to trial as early as January 2019, but those orders were ... Read More

Invokana, similar diabetes drugs, linked to serious genital infection

Invokana and similar type 2 diabetes drugs known as SGLT2 inhibitors have been linked to a disturbing new side effect – necrotizing fasciitis of the perineum, a rotting of the genitals also called Fournier’s gangrene. The Food and Drug Administration (FDA) has ordered the drugs’ labels be updated to include a warning about this disturbing new side effect. Diabetes is one of the risk factors for Fournier’s gangrene, however it is still extremely rare. From March 2013 to May 2018, the FDA identified 12 cases of Fournier’s gangrene in patients taking SGLT2 inhibitors. That number only includes cases that were ... Read More

Invokana sales fall after amputation warnings

When the Food and Drug Administration (FDA) announced in March 2017 that it was requiring Johnson & Johnson and its subsidiary Janssen Pharmaceuticals to add a boxed warning – the strongest warning required by the FDA – to the labels of its type 2 diabetes medication Invokana regarding an increased risk of amputations in users, some doctors and hospital-affiliated medical groups rushed to take patients off the drug. Amputation is already a risk for diabetics. Why worsen the odds? The FDA Safety Communication informed consumers that leg and foot amputations occurred about twice as often in patients taking Invokana than ... Read More

Lawsuits claim diabetes drug Invokana caused leg amputations

Two men have filed lawsuits in the Superior Court of New Jersey Law Division in Middlesex County against Johnson & Johnson unit Janssen Pharmaceuticals alleging the company’s type 2 diabetes drug Invokana caused them to have their legs amputated. Robert E. Shook, 60, of Alabama claims that he had to undergo below-knee, left foot and left leg amputations after taking Invokana. Michael A. Wilkinson, 53, of Iowa, alleges he had to undergo right leg and below-knee amputations after using the drug. Both men have since stopped taking Invokana. The lawsuits claim that Janssen failed to warn doctors and patients that ... Read More

Invokana side effects cases increase substantially since MDL formed last year

More than 940 cases have been filed in the U.S. District Court, District of New Jersey and centralized before a single judge over alleged side effects with the type 2 diabetes drug canagliflozin, known by the brand names Invokana and Invokamet. The cases were first consolidated in December of last year. Pending cases target Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, makers of Invokana and Invokamet. Serious complications linked to use of the drugs include diabetic ketoacidosis, kidney damage, and lower limb amputations, most of which involve the toes. Canagliflozin, the active ingredient in Invokana and Invokamet, is in ... Read More

Memorable Safety Alerts for 2017

The Food and Drug Administration (FDA) issued more than 60 Safety Alerts for drugs and therapeutic biological products in 2017. Here is a sampling of some of the products the agency warned consumers about: Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products – The pads and antiseptic towelettes used to prepare skin prior to injuection and in first aide to decrease germs in minor injuries manufactured by Foshan Flying Medical wererife with quality issues that put the sterility of the products into question. The FDA place all drug products produced by Foshan on import alert to ... Read More

FDA approves new type 2 diabetes drug

The Food and Drug Administration (FDA) approved Steglatro, a new type 2 diabetes drug manufactured by Merck and Pfizer. Steglatro is in a newer class of diabetes drugs called sodium glucose transporter (SGLT) 2 inhibitors, the same class as rival drugs Invokana and Jardiance. It contains the active drug ingredient ertugliflozin, and is approved as a monotherapy in 5- and 15-milligram doses taken once daily, as well as two separate fixed-dose combinations. One fixed dose contains the dipeptidyl peptidase (DPP) 4 inhibitor sitagliptin, and will be sold under the brand name Steglujan, in dosages of 5mg ertugliflozin/100mg sitagliptin and 15mg/100mg, ... Read More

New SGLT2 inhibitor drugs developed despite growing list of side effects

The SGLT2 inhibitor class of type 2 diabetes medications is expected to continue to grow in the coming months with new treatments on the verge of Food and Drug Administration (FDA) approval and positive cardiovascular outcomes data. But the drugs remain saddled with a growing list of side effects. The FDA is currently reviewing a new SGLT2 inhibitor from Pfizer and Merck called ertugliflozin, an oral therapy that lowers blood glucose levels by allowing excess glucose to be secreted through the urine. Merck is also poised to obtain clearance for other ertugliflozin combination drugs, such as one that includes the ... Read More

Amputation risk with Invokana not seen in Jardiance

The increased amputation risk associated with the type 2 diabetes drug Invokana was not seen in patients taking Jardiance, a medication in the same class, according to a new study published in the journal Diabetes Care. In May 2017, the FDA issued a Safety Communication alerting the public that based on new data from two large clinical trials, the agency had concluded that the medicine canagliflozin (the active ingredient in the type 2 diabetes drugs Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations. As a result, the FDA required the safety labels of all ... Read More

Invokana cardiovascular study reveals risks, benefits to kidneys

Patients taking the type 2 diabetes medication Invokana had a reduced risk of kidney disease progression over the course of six years, according to new clinical data. However, the medication still carries warnings that it can cause kidney damage. The study, pulled from the landmark CANVAS clinical trial program, pitted patients taking Invokana against those treated with a placebo. It showed that patients taking Invokana had significantly reduced urinary albumin excretion and stable estimated glomerular filtration rate over the six-year study period. The CANVAS program is the longest, largest and broadest completed cardiovascular outcomes study among all the type 2 diabetes ... Read More