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INVOKANA AND INCREASED RISK FOR AMPUTATIONS GETS FDA BLACK BOX WARNING

Invokana (canagliflozin), an SGLT-2 drug for use in type 2 diabetes (and sometimes type 1) is now required to carry the eminent black box warning by the FDA due to a higher risk for foot and leg amputations. Canagliflozin is the drug present in the marketed products: Invokana, Invokamet and Invokamet XR. It is a drug prescribed for use in combination with exercise and diet to lower blood sugar by forcing the kidneys to move sugar out of the body by excreting it through the urine.

This new requirement is a result of 2 clinical trials whose data revealed these elevated risks. The clinical trials uncovered that foot and leg amputations happened twice as often in those taking Canagliflozin compared to those taking a placebo. There were 2 clinical trials which concluded these revealing results; CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus).

Invokana is Johnson & Johnson’s brand name for Canagliflozin which was approved by the FDA in March 2013. Invokana and other SGLT2 inhibitors (Sodium-glucose contransporter-2 inhibitor) lower blood sugar by causing the kidneys to excrete glucose through the patient’s urine, reducing the amount of glucose in the patient’s blood. However, crucial blood components have also been found to excrete from the patient’s kidneys as well, allegedly leading to severe side effects and complications.

Over the length of a year, the risk for amputations for CANVAS trial patients was equivalent to 5.9 out of every 1,000 pateints taking canagliflozin and 2.8 out of every 1,000 patients taking a placebo.

Over the length of a year, the risk for amputations for CANVAS- R trial patients was equivalent to 7.5 out of every 1,000 patients taking canagliflozin and 4.2 out of every 1,000 patients taking a placebo.

The most common amputations were the toe and foot amputations, however, above and below the knee leg amputations also occurred, some even needing more than one amputation involving both limbs.

If you or a loved one has taken Invokana or other SGLT2 inhibitor and believe an injury was caused as a result, it is recommended you speak with an attorney because you may be entitled to compensation under the MDL litigation process or via settlement. Our attorneys hold drug and medical device manufacturers liable when their products endanger the public. Our attorneys are actively pursuing Invokana settlements and filing Invokana lawsuits against manufacturers on behalf of patients injured or killed from use of these potentially harmful drugs.