FDA Warns Users of Invokana About Risk of Bone Fractures

Gabriel A. Assaad
Partner Gabriel Assaad represents victims of negligence and medical malpractice nationwide.

Living with type 2 diabetes can be overwhelming and stressful for many sufferers. In an attempt to keep their condition under control, many people must combine a special diet with exercise to try and keep their blood sugar at a safe level. In addition, people with type 2 diabetes sometimes turn to medication to treat their condition and prevent further harm. One commonly-prescribed medication is canagliflozin, sold as Invokana and Invokamet. Unfortunately, since its introduction to the market, Invokana as been linked to dangerous adverse side effects. One of the most common dangerous side effects linked to the drug is the risk of developing ketoacidosis. Recently, however, the U.S. Food and Drug Administration issued further warnings relating to the risk of bone fracture and decreased bone density in diabetic patients taking Invokana.

What Is Invokana?

Canagliflozin belongs to a class of drugs that are called sodium glucose cotransporter-2, or SGLT2, inhibitors. Healthy people produce insulin to process sugar that enters their bodies when they eat. People with type 2 diabetes no longer have this response when they eat food, and develop insulin resistance as a result. Sugar levels can rise to dangerous levels when the pancreas is no longer able to keep up with the increased demand for insulin. Drugs belonging to the SGLT2-inhibiting class of medications work by stopping glucose from being reabsorbed into the blood. Invokana is designed to inhibit a special protein in the kidney known as SGLT2. This protein is responsible for reabsorbing 90% of the glucose in the kidneys. The sugar is secreted by the kidneys instead of being reabsorbed. It is then released from the body through urination.

When it is sold as a single-ingredient product, it is known under the label of Invokana. When it is combined with metformin, another diabetes medication, it is known under the label Invokamet. The U.S. Food and Drug Administration approved Invokana as the first in this class in March 2013. Invokamet was approved in 2014. However, as early as May 2015, the FDA was already issuing warnings about the dangers associated with the drug.

6 Facts About the Link Between Invokana and Bone Density and Fracture Risk

After discovering the link between Invokana use and an increased risk of bone fracture and loss of bone density, the U.S. Food and Drug Administration took action. The following is an overview of this important event:

  1. The U.S. Food and Drug Administration has updated the drug’s warning label. It now must include information about an increased risk for bone fractures as well as an increased risk for reduced bone mineral density.
  2. The label already contained information about the risk for bone fractures. This information was stated in the “adverse reactions” section of the label.
  3. Recent clinical trials confirmed evidence that Invokana use increases the risk of bone fracture. As a result, the FDA is now requiring that information about the risk be listed under the “warnings and precautions” section of the label.
  4. Bone fractures were seen in patients as early as 12 weeks after starting canagliflozin.
  5. Another clinical trial demonstrated that elderly patients taking the drug for more than two years suffered losses in bone mineral density in the hips and lower spine. This information was added to the “adverse reactions” section of the medication’s label.
  6. The FDA further recommends that health care professionals consider whether a patient has any risk factors.

While the FDA’s newest drug safety communication regarding the risks of bone fracture and loss of bone density in patients taking Invokana is alarming for many patients, it is important not to stop taking the drug without first consulting with a physician. Untreated diabetes can lead to seriously harmful side effects in people suffering from the condition. For example, untreated type 2 diabetes may lead to blindness, nerve damage, kidney damage, and heart disease. 

If you took Invokana and are now suffering harmful adverse side effects, you may have a cause of action against the drug’s maker, Johnson & Johnson. It is crucial to seek guidance from an experienced legal professional to protect your rights whenever dealing with harm caused by a dangerous drug. Fortunately, we have the background that you need. We have helped many clients obtain the compensation they deserve. Our successful case results speak for themselves. We encourage you to contact us today at 855-947-0707 for more information.