Tagged Articles

bone fractures 18 articles

Dismissed Fosamax bone fracture lawsuits revived by appeals court

About 5,000 lawsuits alleging femur fractures caused by Merck’s osteoporosis drug Fosamax that had been dismissed in federal and state courts were given new life when the U.S. Court of Appeals for the Third Circuit overturned the dismissal. The appeals court found that the District Court misapplied the U.S. Supreme Court’s 2009 ruling in Wyeth v. Levine, during which the Supreme Court held that state-law failure-to-warn claims are preempted when there is evidence that the Food and Drug Administration (FDA) would not have approved a warning label that those suing the drug company claim was necessary. In June 2014, U.S. ... Read More

Top 5 most dangerous Invokana side effects

The type 2 diabetes drug Invokana hit the market in 2013 with much hype. It was the first drug in a new class of diabetes treatments known as SGLT2 inhibitors. Johnson & Johnson and its unit Janssen Pharmaceuticals, stood to make millions – if not billions – from its novel new diabetes pill. Unlike other diabetes drugs that work through the pancreas or liver, SGLT2 inhibitors are metabolized through the kidneys and lower blood sugar levels by excreting excess sugar through the urine. Invokana, which contains the drug ingredient canagliflozin, proved to be a huge hit and remains a top seller ... Read More

Invokana timeline reveals growing list of warnings

In March 2013, the Food and Drug Administration (FDA) approved a novel new type 2 diabetes treatment called Invokana. The drug, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals, was the first in a class of diabetes drugs known as SGLT2 inhibitors. Unlike other diabetes medications that work through the pancreas or liver, Invokana lowers blood sugar by pushing excess sugar through the kidneys where it is excreted through the urine. The drug was almost an immediate hit, offering the benefit of weight loss to a population of patients often plagued by obesity. Other drugs, such as the Invokana and insulin ... Read More

Study finds Invokana effective despite side effects warnings

A researcher who works for Janssen Scientific Affairs, a division of Johnson & Johnson’s Janssen Pharmaceuticals, conducted a year-long study comparing the company’s type 2 diabetes drug Invokana with the diabetes drug glimepiride and determined that Invokana was better at improving glycemic control, blood pressure and weight loss than glimepiride in patients with type 2 diabetes. The study was presented last month at the AACE Annual Scientific and Clinical Congress. Invokana, known chemically as canagliflozin, is in a newer class of type 2 diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. They lower blood sugary by causing the kidneys to ... Read More

Elderly patients more vulnerable to Invokana side effects

A pooled analysis of adverse event reports in patients taking the type 2 diabetes medication Invokana found that patients 75 years and older were more likely to suffer Invokana side effects compared to patients younger than 75 treated with the drug. The study, published in The Journal of the American Geriatrics Society, was designed to compare the efficacy and safety of Invokana in younger patients versus elderly patients. Researchers measured HbA1c, fasting blood glucose, blood pressure and body weight for participants. Efficacy was evaluated using pooled data from six randomized, double-blind, placebo-controlled studies. Safety was assessed based on adverse event ... Read More

FDA: Invokana, Invokamet linked to foot, toe amputations

People who take the type 2 diabetes medication Invokana or Invokamet, both of which contain the active drug ingredient canagliflozin, are at an increased risk of foot amputations, mostly affecting the toes, the Food and Drug Administration (FDA) warned. The Safety Alert comes just weeks after the European Medicines Agency (EMA) announced that it was conducting an investigation into reports of lower limb amputations, specifically toe amputations, with the drug. The FDA said that results from an ongoing clinical trial found an increased risk of foot and toe amputations in patients treated with Invokana and Invokamet. The agency said it ... Read More

Invokana plagued by new side effects since its FDA approval

It’s been three years since the Food and Drug Administration (FDA) approved Johnson & Johnson’s Janssen Pharmaceutical’s drug Invokana (canagliflozin) as a treatment for type 2 diabetes. Since then, the FDA and other drug regulators have issued numerous warnings over new Invokana side effects that have emerged outside initial clinical trials. Invokana was the first drug approved in the United States in a class known as sodium glucose cotransporter 2 (SGLT2) inhibitors. Prescriptions for the drug have since soared, generating hundreds of millions in revenue. In May 2015, the FDA issued a Safety Communication warning that Invokana and two other ... Read More

Man sues Invokana makers over serious blood disorder

Johnson & Johnson subsidiary Janssen Pharmaceuticals is being sued by a Texas man who claims the company’s type 2 diabetes drug Invokana caused him to develop ketoacidosis, a potentially life-threatening condition in which too much acid builds up in the blood. Arthur Portnoff, who filed his lawsuit in Philadelphia Court of Common Pleas, claims he began taking the drug in November 2014 and was hospitalized in February 2015 with ketoacidosis. He claims that Janssen knew the drug could cause serious injuries but failed to adequately warn patients or doctors of this risk. His complaint also states that Janssen did not ... Read More

FDA adds two new warnings to diabetes drug Invokana

The Type 2 diabetes treatment Invokana hit the market in 2013 as the first drug in a new class of diabetes medications known as SGLT2 inhibitors. As with all new diabetes drugs, the Food and Drug Administration (FDA) ordered Johnson & Johnson’s unit Janssen Pharmaceuticals to collect data on heart risks. However, recent FDA alerts suggest that Invokana, and possibly other SGLT2 inhibitors, may carry other serious health risks. Janssen is still collecting data on cardiovascular events in patients using Invokana. But last week, Eli Lilly and Co. announced that its SGLT2 inhibitor Jardiance cut death risk in diabetic patients ... Read More

Type 2 diabetes drug class shares risk/benefit profiles

Johnson & Johnson is arguing that its type 2 diabetes treatment Invokana should have the same life-saving capabilities as its rival drug Jardiance showed in a new, large clinical trial. Jardiance, made by Eli Lilly and Co., announced last month results from a three-year study that showed Jardiance cut death risk by 32 percent in patients with type 2 diabetes at risk of heart attack and stroke. The news sent prescriptions for the drug skyrocketing, nearly doubling for the quarter to $340 million. Johnson & Johnson, whose drug Invokana shares the same class as Jardiance, wants in on that action. ... Read More