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Invokamet 63 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 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

Invokana amputation risk does not apply to other drugs in class

The lower limb amputation risk with the type 2 diabetes drug canagliflozin, the active ingredient in the brand-name drugs Invokana, Invokamet and Invokamet XR, does not apply to other diabetes drugs in its class, according to an Advera Health analysis. Currently, only diabetes medications containing canagliflozin carry black box warnings regarding an increased risk of toe, foot or leg amputations. A boxed warning is the strongest warning issued by the Food and Drug Administration (FDA), and is designed to call attention to serious or life-threatening risks. The FDA’s warning was announced after the agency reviewed data from the CANVAS and ... Read More

J&J seeks to expand Invokana use despite added warnings

Johnson & Johnson has submitted a supplemental new drug application (sNDA) to the Food and Drug Administration (FDA) to expand the label of its type 2 diabetes medication Invokana to include a new cardiovascular indication. The request comes less than six months after the drug’s label was updated to include a boxed warning for a new disabling side effect – amputation. Invokana was approved by the FDA in 2013 as an adjunct to diet and exercise to improve glycemic control an adults with type 2 diabetes. The sNDA seeks the indication of risk reduction of cardiovascular events in type 2 ... Read More

Some doctors have stopped prescribing Invokana

New warnings regarding an increased risk of lower limb amputations with diabetes drugs containing canagliflozin have prompted some California doctors to transition patients off the medication, especially if they have key risk factors such as prior amputations. It is a “process that has been underway since the FDA warnings came out,” John Chomsky, a spokesman for Sharp HealthCare system in San Diego, California, told KPBS. Two large studies involving patients taking type 2 diabetes medications containing canagliflozin, which includes the brand-name drugs Invokana, Invokamet and Invokamet XR, showed that the medications doubled the risk of lower limb amputation compared to ... Read More