Articles Tagged with amputation

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Patient Loses Leg After Taking Invokana

Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

The clinical trials were named CANVAS and CANVAS-R, based on long scientific acronyms. The studies examined the effects of canagliflozin on patients with Type-2 diabetes. The trials discovered that leg and foot amputations occurred twice as often in patients taking canagliflozin as those treated with a placebo.

The risk for amputations broke down like this: 5.9 out of every 1,000 patients treated with canagliflozin suffered amputation, as compared to 2.8 out of every 1,000 patients treated with a placebo. Over a year’s time, the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 out of every 1,000 patients treated with a placebo. These are statistically significant results, meaning the risk of amputation for those people taking Invokana was large enough to cause alarm in the medical community.

In the clinical trials, amputations of the toe and middle of the foot were the most common; however, amputations of the leg, below and above the knee, also occurred. Some patients had more than one amputation.

Based on this new data, the FDA ordered new warnings, including a prominent boxed warning, to be added to the canagliflozin drug labels to explain and describe this risk.   Continue reading →

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Diabetes Drug InvokanaDiabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.