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Continuation of Clinical Trial Results Concerning Invokana Amputation Risks

On Behalf of | Apr 18, 2019 | Uncategorized

Invokana is a popular diabetes drug that is commonly administered to lower blood sugar in diabetes patients. However, clinical trials point to the conclusion that Invokana may increase the risk of amputations in diabetics. Here, the pharmaceutical liability attorneys at The Law Offices of Peter Angelos provide updates on the clinical trial results concerning Invokana amputation risks.

Diabetes Patients Have a Higher Risk of Needing an Amputation

As a result of improper glucose regulation, nerve damage and poor circulation in diabetes patients, there is a higher risk of developing infections that necessitate an amputation. In the United States, almost 67% of amputations are linked to diabetes and the amputation rate for diabetics is 28 times higher than individuals without diabetes. Most amputations are performed on the toes and feet, but some diabetes patients with severe infections may require amputations below the knee.

With the percentage of people in the U.S. with diabetes rising from 18.2 million in 2003 to the current 30.3 million, diabetes-related amputations are becoming an even greater issue than in past years. This issue is elevated by certain prescription diabetes medications, such as Invokana, that have been found to increase the amputation risk in diabetes patients.

Clinical Trials Studied Link Between Invokana and Increased Amputation Rate in Diabetics

Invokana, which also goes by the name of canagliflozin, is a popular prescription medication used for treating patients with type 2 diabetes. It is part of a class of drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which cause excess sugar in the body to be removed through urine. According to Janssen Pharmaceuticals, which licenses Invokana, the drug lowers blood sugar in diabetes patients. However, while already known side effects of Invokana include broken bones, ketoacidosis, kidney issues and urinary tract infections, researchers are finding that the popular drug may also increase the risk of amputations in diabetics.

Suspicions that Invokana may be linked to the increased risk of amputations resulted in the development of two major clinical trials, CANVAS and CANVAS-R. Data collected during the trials found that leg and foot amputations were twice as likely to occur in patients treated with canagliflozin compared to patients being treated with a placebo. As a reaction to the findings of the trials, the FDA began requiring a black box warning to be added to Invokana labels, which is the highest warning the FDA can require on a product. Ultimately, findings showed that one in every 69 patients being treated with Invokana for five years would suffer a drug-related amputation.

Researchers Are Still Attempting to Secure Connection Between Invokana and Amputations

Despite the clear connection between Invokana and the increased risk of amputations in diabetes patients, it is still unclear exactly why the drug causes the increased risk. Some doctors theorize that the possible linkage is due to the possibility that Invokana causes blood to thicken and pool in the foot, despite claims that the drug decreases blood pressure.

While Johnson & Johnson made upwards of $248 million in Invokana sales in 2018, sales have dropped in recent years, with a 12% decline in sales in the first quarter of 2018. These large dips in sales are connected to the increased danger of requiring an amputation among other risks.

Speak to a Pharmaceutical Liability Attorney at The Law Offices Of Peter Angelos for More Information

As the rate of diabetes in the United States continues to increase every year, the responsibility for doctors and medical researchers to properly treat and find solutions for diabetes patients grows stronger. The connection between a popular diabetes drug and amputations demonstrates the dangers of medical faults to the health and lives of Americans in need of proper treatment. If you have been prescribed Invokana to treat your type 2 diabetes and suffered an infection, circulation issues or nerve damage that required amputation below the knee, you may be entitled to pursue compensation. Contact The Law Offices of Peter Angelos to learn more.