an increased risk of bone fracture
Diabetes Patients Taking Invokana Are Facing Greater Risk. The Food and Drug Administration (FDA) is advising people taking canagliflozin (Invokana, and Invokamet) that they face an increased risk of bone fracture, as reported in their latest study.
The FDA has raised the warning on its labels for canagliflozin, a type 2 diabetes medication due to an increased risk of bone fracture.
The agency also included that it found evidence of decreased bone density. This is a sign of the health of a person’s bones.
In response to these concerns, The FDA has added a new Warning and Precaution and adjusted the Adverse Reactions section of the Invokamet and Invokana labels.
The Food and Drug Administration will continue to study the likelihood of bone fractures with other drugs in the SGLT-2 inhibitor class, Including Synjardy, Glyxambi, and Jardiance (empagliflozin) and Xigduo, and Farxiga, (dapagliflozin) to see if these medications are also responsible for lowering bone density as well. If so, labeling changes will also have to be done for these medications.
Canagliflozin is a prescription medication used in combination with diet and exercise to reduce blood sugar levels in adults with type 2 diabetes. It is part of a class of drugs identified as Sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Canagliflozin can be prescribed as a single ingredient medication using the brand name Invokana and in combination with metformin using the brand name Invokamet.
The FDA now advises healthcare professionals to consider the factors that contribute to the risk of fractures before prescribing canagliflozin. Patients should be questioned if there are activities which put their bones at increased risk of fracture. The FDA also warns patients not to stop or change any diabetic medication without first consulting with their doctor, or healthcare professional.
The FDA reminds patients that when type-2 diabetes is not treated, it can result in serious health complications such as heart disease, kidney and nerve damage, as well as blindness.
According to the FDA, the announcement was issued because patients taking canagliflozin were experiencing bone fractures. These fractures were occurring in as little as 12 weeks after people were first given the medication. Canagliflozin has since been linked to the decreased bone density of the lower spine and hip.
Additional serious concerns have been added to the risks associated with Canagliflozin. Important side effects include:
- Mostly the removal of a toe, or a part of the foot. However, amputations are reported both bellow and above the knee. You could be at a greater risk of a leg, or a foot amputation if you have a history of amputations or if you have blocked or narrowing blood vessels in the legs, have neuropathy or sores or foot ulcers.
- Invokana has caused people to experience dehydration which can lead to weakness, dizziness, lightheadedness, and fainting. Talk to your physician about prescription medications that you are taking to lower your blood pressure, have kidney problems, or if you are on a low salt diet.
If you are allergic to canagliflozin or any of the ingredients of Invokana, you should not take it. Symptoms of an allergic reaction can be: swelling of the throat, making it hard to breathe or swallow, swelling of the tongue, lips, or face, rashes, or red patches on your skin. If any of the following symptoms develop, stop taking Invokana and call your doctor at once: nausea, trouble breathing, stomach area pain, vomiting.
Parker Waichman LLP is a national law firm with extensive and successful experience in product liability litigation. If you have questions regarding medication and their side effects call us today at 1-800-yourlawyer, (1-800-968-7529) for a free case evaluation.
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