FDA Warns of Invokana Amputation

By June 17, 2016February 28th, 2018Invokana

Invokana diabetic ketoacidosisData from an ongoing study revealed a risk of amputation among people taking the diabetes drug Invokana. This data prompted the US Food and Drug Administration (FDA) to release a safety update about Invokana, and the version of the drug with metformin, Invokamet, in mid-May 2016.

The study—Canagliflozin Cardiovascular Assessment Study (CANVAS)—followed participants for almost 5 years. During that period, researchers found a twofold increase in the risk of amputation among participants taking Invokana versus a placebo.

About 7 out of every 1,000 participants taking 100 mg of Invokana (canagliflozin) per day underwent amputation. The risk lowered slightly in participants taking 300 mg of Invokana per day and in those taking a placebo.

Amputation of legs, feet, and toes were most common among CANVAS participants.

Invokana has also been linked to diabetic ketoacidosis, a serious condition that often requires hospitalization, and is potentially fatal.

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