September 16th, 2015|
On September 10, the FDA reported that type II diabetes medications Invokana and Invokamet (active ingredient canagliflozin) may increase the risk of bone fractures as well as decrease bone mineral density, which relates to bone strength.
Addressing these new safety risks, the FDA updated the “Adverse Reactions” section of the product label for Invokana and Invokamet and added a new “Warning and Precaution” for the drugs.
A clinical trial of Invokana in 714 elderly patients with type II diabetes showed the drug caused a significant loss of bone mineral density in the hip and lower spine, versus placebo. In other trials, bone fractures were found to occur in as little as 12 weeks after starting medication, often resulting from only minor trauma such as falling from standing height.
Canagliflozin, the active ingredient in Invokana and Invokamet, belongs to a class of relatively new diabetes drugs called SGLT-2 inhibitors, which work by causing blood sugar to leave the body mostly through urine. Invokana and Invokamet are both manufactured by Johnson & Johnson/Janssen, and have enjoyed a great deal of market success since they were respectively approved in 2013 and 2014 by the FDA.
The FDA is presently evaluating the risk of bone fractures and decreased bone strength with other SGLT-2 inhibitor drugs, to see if further safety warnings or studies are needed. The FDA is looking at Astra Zeneca’s Farxiga and Xigduo XR (active ingredient: dapagliflozin) and Lilly/Boehringer Ingelheim’s Jardiance, Glyxambi, and Synjardy (active ingredient: empagliflozin).
Other Invokana side effects
Invokana and other SGLT-2 inhibitors have also been linked to increased risk of:
- Kidney damage
- Heart attack
- Diabetic ketoacidosis (DKA)
Diabetic ketoacidosis is a serious, potentially life-threatening medical condition, in which the body breaks down fat in absence of insulin for energy. This makes the blood more acidic. If you experience the following symptoms while using Invokana or another SGLT-2 inhibitor, you should immediately seek medical attention:
- Difficulty breathing
- Unusual fatigue or sleepiness
- Frequent urination or thirst lasting for a day or more
- Flushed face
- Fruity-smelling breath
- Aching muscles or muscle stiffness
- Vomiting and nausea
- Stomach pain
The FDA encourages patients and physicians to report adverse events or side effects related to their use of a prescription drug to the agency’s MedWatch program. The information you provide is valuable to strengthening understanding of the potential health risks of a given prescription drug.
A link to fill out and submit this report can be found here.
We want to help
Cory Watson Attorneys has represented people injured by pharmaceutical drugs for more than thirty years and are available to provide a free legal consultation. If you or a loved one were injured by Invokana or another prescription drug, call today for a free consultation. (877) 686-8992