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Invokana Linked to Increased Bone Fracture Risk: FDA Warning

The FDA has strengthened warnings for canagliflozin to note that the drugs may increase the risk of bone fracture and decrease bone mineral density.

The U.S. Food & Drug Administration (FDA) has strengthened warnings for the type 2 diabetes medication canagliflozin (trade names Invokana, Invokamet) to note that the drugs may increase the risk of bone fracture and decrease bone mineral density.

Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Invokana or Invokamet, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

What’s the problem?

September 10, 2015 – In a drug safety communication issued today, FDA announced that it had added the following information to the adverse reactions section of Invokana and Invokamet’s labeling:

  • Bone fractures have been observed in patients treated with canagliflozin.
  • Fractures can occur as early as 12 weeks after initiating treatment.
  • In addition to bone fractures, canagliflozin has also been found to decrease bone mineral density at the hip and lumbar spine.

FDA’s warning came in response to an evaluation of 9 pooled clinical trials with an average canagliflozin exposure of 85 weeks. The incidence rates of bone fractures was:

  • 1.1 in the comparator group
  • 1.4 for those on 100 mg of canagliflozin
  • 1.5 for those on 300 mg of canagliflozin

The bone fractures were more likely to be low trauma and involve the upper extremities.

Post-Marketing Surveillance

FDA also noted that a post-marketing trial of 714 patients was conducted to evaluate the safety of Invokana and Invokamet. After 2 years, patients randomized to 100 mg of canagliflozin had placebo-corrected declines of 0.9% in bone mass density of the hip, and those taking 300 mg had a 1.2% decline. Patients also had a 0.3% decline and 0.7% decline, respectively, at the lumbar spine, and declines were also observed in the femoral neck and distal forearm.

Last year, a study published in Lancet Diabetes and Endocrinology looked at the potential link between canagliflozin and bone fractures, especially in post-menopausal women. The researcher cited numerous studies indicating a possible link as evidence.

Do I Have an Invokana Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana Lawsuits. We are handling individual litigation nationwide and currently accepting new side effects cases in all 50 states.

Free Invokana Lawsuit Evaluation: Again, if you were harmed by a diabetes drug, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.

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