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FDA Gives Diabetes Drug Highest Warning Due to Increased Amputation Risk

Posted on in Catastrophic Injuries

California accident attorney, California injury lawyerThe U.S. Food and Drug Administration released a drug safety communication in May regarding type 2 diabetes medication canagliflozin, also known as Invokana, Invokamet, and Invokamet XR. After the results of two large clinical trials, the FDA found that canagliflozin increases the risk of leg and foot amputations – an already significant issue for diabetes sufferers. The FDA found the increased risk so great as to warrant a Boxed Warning, which is the highest warning label for drugs.

Heightened Amputation Risk

Canagliflozin is a medication used in combination with diet and exercise to lower an individual’s blood sugar. It is a sodium-glucose cotransporter-2 inhibitor, which lowers blood sugar by causing the kidneys to take sugar from the body and dispose of it through the urine.

Through two large clinical tests, which tested the efficacy and safety of canagliflozin, researchers saw that patients taking the drug suffered approximately twice as many toe, leg, and foot amputations as patients treated with an inactive placebo. Over the course of one year in the first study, 5.9 out of 1,000 patients taking canagliflozin had to have an amputation compared to only 2.8 out of 1,000 patients taking the placebo. In the second study, after one year, 7.5 out of 1,000 patients on canagliflozin had an amputation compared to 4.2 out of every 1,000 patients on a placebo.

Preventing Unnecessary Amputations

The FDA warns that health care professionals need to consider a patient’s current risk of amputation prior to prescribing this medication. If a patient has a history of diabetic foot ulcers, neuropathy, peripheral vascular disease, or a previous amputation, then this medication is not for him or her.

Patients should be fully informed of the risks associated with this drug prior to agreeing to take it. That is why the FDA put a boxed warning label on the drugs. This is the highest warning label available for drugs and designates that taking the medication comes with serious or life-threatening risks.

While a patient is on this medication, he or she must be thoroughly monitored by a physician. If signs of complications arise, such as pain, tenderness, foot sores or ulcers, or infections, then the patient should stop taking the drug.

Were You Not Warned about a Drug’s Amputation Risk?

The risks associated with canagliflozin are not brand new. This FDA communication follows a warning given in May 2016 based on interim clinical trial results. Physicians who work with diabetic patients should already have been aware that an increased risk of amputation may have been an issue associated with this drug and proceeded with caution.

If you were prescribed this medication without any discussion of the risks associated with it or about the amputation risk specifically, you may have an injury claim. To have your situation reviewed by an experienced San Jose defective product attorney, contact at the Jachimowicz Law Group at 408-246-5500 to schedule your first meeting with our firm. We can take a look at what happened and advise you on your rights and legal options.




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