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Invokana and Invokamet 43 articles

FDA approves updated warning label on diabetes drug Farxiga

The Food and Drug Administration (FDA) has approved changes to the safety label of the type 2 diabetes drug Farxiga to include stronger warnings for the risk of acute kidney injury. The update replaces the previous warning for impaired renal function. The warning states that Farxiga causes intravascular volume contradiction, which can lead to renal impairment. The FDA and the drug companies have received post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients taking Farxiga. Some of the reports involved patients younger than 65. “Before initiating Farxiga, consider factors that may predispose patients to acute kidney ... Read More

EMA expands toe amputation risk investigation to other SGLT2 inhibitors

The European Medicines Agency (EMA) has extended the scope of its investigation into the risk of lower limb amputations with the type 2 diabetes drugs Invokana and Invokamet to include other drugs in the class. Invokana and Invokamet contain the active ingredient canagliflozin, which is in a class called sodium glucose cotransporter 2 (SGLT2) inhibitors. The EMA’s investigation will now also focus on other SGLT2 inhibitors such as dapagliflozin (which includes the brand names Farxiga and Xigduo XR) and empagliflozin (which includes the brand name Jardiance). The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) launched a safety review on canagliflozin in ... Read More

FDA strengthens boxed warning for diabetes drug Xigduo XR

The Food and Drug Administration (FDA) has approved safety label changes for the type 2 diabetes drug Xigduo XR that give more extensive updates to the boxed warning involving the risk for lactic acidosis. Lactic acidosis is a medical condition characterized by the buildup of lactate in the body. Lactic acidosis in patients taking Xigduo have reportedly resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. “The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain,” the updated warning states. Xigduo is a combination of the medications ... Read More

UK, US launch investigations into lower limb amputation risk with Invokana

A clinical trial showing that patients taking the newer type 2 diabetes drugs Invokana or Invokamet are at twice the risk of lower limb amputations, primarily of the toe, has prompted the European Medicines Agency (EMA), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and U.S. Food and Drug Administration (FDA) to launch an investigation into whether new warnings should be placed on the drug’s safety label. Amputation is already a health risk for diabetic patients due to neuropathy, or nerve damage, particularly in the toes, feet and legs. According to the study, the risk of lower limb ... Read More

In 2014, analysts warned that Invokana side effects could be worse than expected

In March 2013, Johnson & Johnson’s Janssen Pharmaceuticals became the first company granted market approval for a type 2 diabetes treatment from a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokana, known chemically as canagliflozin, was followed a year later by the company’s canagliflozin-plus metformin combo pill Invokamet, and quickly rose to blockbuster status despite other SGLT2s entering the market since then. But just months after Invokana hit the market, analysts were already warning that while the drugs were associated with increased risk of urinary tract infections, the medications may also be linked to more serious ... Read More

Diabetics should be screened for kidney problems before starting Invokana

Health care providers are advised to consider factors that may predispose patients to acute kidney injury before prescribing them the type 2 diabetes drugs Invokana and Farxiga following an announcement by the Food and Drug Administration (FDA) that it was strengthening the current warning about acute kidney injury on the drugs’ safety labels. The strengthened warnings apply to the brand name diabetes drugs Invokana and Invokamet (which include the active drug ingredient canagliflozin), and Farxiga and Xigduo XR (which contain the drug dapagliflozin). The drugs are in a class known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. They are used with ... Read More

Warnings mount against Invokana, other SGLT2 inhibitors

The Food and Drug Administration (FDA) has strengthened warnings for acute kidney injury on the type 2 diabetes drugs Invokana, Invokamet, Farxiga, and Xigudo XR, but left the warning off Jardiance, a medication from the same drug class. In fact, a recent study by Jardiance maker Eli Lilly & Co. found that Jardiance cut the risk for new-onset or worsening kidney disease by 39 percent. The medications belong to a class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors. Invokana, made by Johnson & Johnson’s Janssen Pharmaceuticals, was the first drug in the class to hit the market ... Read More

Janssen fights to dismiss Invokana lawsuit filed in PA state court

A Texas man has filed a lawsuit against Johnson & Johnson’s Janssen Pharmaceuticals in Philadelphia state court over claims that the company’s type 2 diabetes medication Invokana caused him to develop life threatening diabetic ketoacidosis. But the drug company contends that the man’s lawsuit should be thrown out because it has no business being in Philadelphia County. Matthew Landes’ lawsuit is one of 41 filed in the Court of Common Pleas in Philadelphia County involving the alleged Invokana side effect of ketoacidosis, and one of 39 filed by people who don’t live anywhere near the county. The drug company argued that ... Read More

Increased risk of kidney injury, renal impairment with Invokana, Invokamet

The type 2 diabetes treatments Invokana and Invokamet have been updated to include new warnings for acute kidney injury and impaired renal function. Invokana contains the drug ingredient canagliflozin. Invokamet contains canagliflozin in combination with the first-line diabetes treatment metformin. The medications were approved by the Food and Drug Administration (FDA) in 2013 and 2014, respectively. Invokana and Invokamet work by inhibiting sodium glucose co-transporter 2, a carrier that aids in the reabsorption of glucose into the bloodstream through the kidneys, and eliminated through the urine. The new warning states: Invokana and Invokamet cause intravascular volume contraction and can cause renal ... Read More

Johnson & Johnson’s 1Q sales show modest decline

Johnson & Johnson saw only a small decline in first-quarter profits thanks in part to booming sales of its prescription drugs, including the blood thinner Xarelto, but sales of its baby care items, which includes Johnson’s Baby Powder, took a beating by competition. Johnson & Johnson, the world’s largest producer of health care products, reported net income of $4.29 billion, down from $4.32 billion from the first quarter of 2015. Despite this, the company did beat Wall Street’s modest expectations. Johnson & Johnson is a multi-billion-dollar-earning multinational medical devices, pharmaceutical and consumer packaged goods manufacturer that produces everything from over-the-counter ... Read More