FDA Adds New Warning Labels to Diabetes Medication Invokana, Citing Increased Risk of Bone Fractures In Addition to Previous Warning of Ketoacidosis

September 16, 2015
FDA Adds New Warning Labels to Diabetes Medication Invokana, Citing Increased Risk of Bone Fractures In Addition to Previous Warning of Ketoacidosis

Type II Diabetes is a very serious medical condition that impacts millions of Americans. The Center for Disease Control (CDC) estimates that as many as 29 million Americans are currently living with some form of Diabetes. Unlike Type I Diabetes, many people with Type II Diabetes may be able to control their blood sugar levels through a combination of proper diet, exercise, and medication.

Unfortunately, many medications that promise to help patients control and overcome the symptoms of Type II Diabetes have been proven to cause unforeseen and dangerous side-effects.

Invokana is one of a new class of drugs known as “SGLT2 inhibitors.” Invokana was first approved for use by the FDA in 2013. When combined with diet and exercise, Invokana was marketed and promoted to doctors as a method to help their patients with Type II Diabetes control their blood sugar levels.

On May 15, 2015, the FDA warned consumers that using this class of drugs may lead to a severe adverse reaction known as “ketoacidosis.” When this condition arises blood sugar and acidic “ketones” in the body spike, causing symptoms such as excessive thirst, frequent urination, nausea and vomiting, abdominal pain, weakness or fatigue, shortness of breath, fruity-scented breath, and confusion. Left untreated, this condition can be fatal.

This last Thursday, September 10, 2015, the FDA announced further action for Invokana and other SGLT2 inhibitors. It will be placing new warning labels that alert patients that the medication has been linked to an increased risk of bone fractures and loss of bone density. These new labels will also counsel patients that they should consult with their doctor or a medical professional before beginning treatment on Invokana.

For older patients, in particular, the loss of bone density can have a permanent and devastating impact on their lives. The risk of severe or even fatal injury from falls is already much greater for older Americans and decreased bone density only heightens that risk.

In addition to the warnings for ketoacidosis, the FDA’s new warning labels will alert patients taking Invokana of several important facts about the medication, including:

  • Invokana’s active ingredient, canagliflozin, has been proven to increase the risk of decreased bone mineral density in patients, especially in the hips and lower spine.
  • Fractures and loss of bone density can begin as early as 12 weeks into the treatment of this medication.
  • The risk of bone fractures may be greater for post-menopausal women.

If you or a loved one suffered from ketoacidosis, broken bones, fractures, or any other serious injury after taking the diabetes medication Invokana, or other SGLT2 inhibitors, you may be entitled to compensation. Call the experienced Tulsa Defective Drug attorneys at Graves McLain for a FREE, confidential, no-obligation consultation about your case.

Your time to file a claim against the manufacturers of Invokana may be limited, so call Graves McLain now at 918-359-6600.

At Graves McLain, Tulsa Defective Drug, and Personal Injury law firm, we stand up to major drug manufacturers on behalf of our injured clients. If you suffered an adverse medical reaction after taking a dangerous or defective medication, you may be able to seek money to pay for your medical bills, lost wages and pain, and suffering.

You can trust the experienced legal team at Graves McLain to stand up for your rights as a victim and secure the maximum compensation for your claim.

At Graves McLain, we know that your case and your injuries are serious, and we treat them that way. If we take your case, you will never pay an attorney’s fee unless we achieve a recovery for you. Trust Graves McLain to handle your Defective Drug case. We don’t get paid until you do. It’s that simple.

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