Prescribing drugs off label is more common than you might think. In fact, doctors write about 1 in 5 prescriptions today for off-label use. This legal practice means that your doctor prescribes the medication for a condition not specified on the FDA’s packaging. It can be beneficial in some cases, and off-label prescribing can eventually lead to FDA approval. But in some cases, taking prescriptions off label can be risky — or even fatal.
Two Dangerous Off Label Reasons to Take Invokana That Aren’t FDA-Approved
Unfortunately, some doctors prescribe type 2 diabetes drug Invokana to type 1 and non-diabetic patients off label. This can be extremely harmful or even life-threatening, according to recent studies. Let’s take a closer look at two popular reasons why doctors prescribe Invokana to patients off label and why they’re not worth the risk.
Off Label Use #1: Weight Loss
Invokana manufacturer Johnson & Johnson explored using this powerful drug for controlling blood sugar as a weight-loss aid in non-diabetics. The company presented results from a Phase II clinical trial at the American Diabetes Association Scientific Sessions in June 2016. For this off label trial involving non-diabetic subjects, researchers combined Invokana with an older weight-loss drug called phentermine. And nearly 2 in 3 participants given this off label combination actually lost 7.5% of their total body weight.
During a 26-week period, researchers randomly gave the study’s 334 subjects one of the following:
- The two-med combo containing phentermine and canagliflozin (Invokana’s active ingredient)
- Phentermine alone
- Invokana alone
- A placebo
Participants taking just phentermine lost 4.1% total body weight, and the Invokana-only group lost 1.9% total body weight. It’s probably not a surprise that the placebo group only lost .6%, the lowest amount.
After those results, more doctors started prescribing Invokana off label for weight loss. Then, a 2016 follow-up study found using Invokana off label for weight loss stopped working after six months. After that, they found subjects’ appetite tripled in strength. So, they slowly regained almost all the weight they’d lost. After a year, no subject taking Invokana off label lost more than 9 pounds. Considering Invokana’s dangerous side effects, taking it off label to shed a few pounds hardly seems worth the risk.
Using Invokana off label can cause chronic UTIs, yeast infections and dehydration. It also more than doubles your lower-limb amputation risks. Are you willing to lose a toe or foot just to lose a few pounds? If not, you should think long and hard before taking Invokana off label for weight loss!
Off Label Use #2: Helping Type 1 Diabetics Control Blood Sugar Spikes After Meals
Invokana is strictly FDA-tested and approved to regulate blood sugar in type 2 diabetes patients, not those with type 1. But more and more doctors are prescribing Invokana to type 1 diabetics off label to help combat post-prandial spikes. However, type 1 diabetics taking Invokana face potentially life-threatening side effects that are unique to people with their specific diagnosis.
A 2016 study found type 1 patients taking Invokana were much more likely to develop diabetic ketoacidosis (DKA). DKA can be fatal, and it happens when cells in your body can’t get the glucose they need for energy.
This randomized, off label Invokana trial tested 117 type 1 diabetics divided into three different subject groups:
- 100mg Invokana daily (Group 1)
- 300mg Invokana daily (Group 2)
- Placebo (Group 3)
After 18 weeks, ketone-related adverse events (like DKA) affected 5.1% of the 100mg and 9.4% of the 300mg group. No placebo group subjects, however, had the same reactions.
The authors concluded, “Because of the potentially life-threatening nature of DKA in patients with type 1 diabetes, further development of SGLT2 inhibitor therapy as a treatment for type 1 diabetes should proceed with caution.”
How Injured Invokana Patients Can Get Justice and Compensation
While off label uses for prescriptions aren’t always a bad idea, taking Invokana this way can be extremely dangerous. Even when doctors prescribe Invokana to help type 2 diabetics lower blood sugar, those patients still risk life-threatening side effects. Invokana can cause strokes, kidney damage, or ketoacidosis. And one recent FDA Invokana warning confirms the drug more than doubles your risk for losing a toe, foot or leg.
If you or someone you love took Invokana off label and experienced serious side effects, you may qualify for compensation. Type 2 diabetics who lost a foot, leg or toe at least 90 days after starting Invokana may also qualify for a significant cash settlement. To check your eligibility for compensation, take two minutes to complete your free Invokana claim evaluation online now. Once you’ve submitted your information, an experienced lawyer will call you to discuss your case.
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.