Pharmaceutical

FDA approves boxed warning on Invokana label

Invokana 149x210 FDA approves boxed warning on Invokana label The labels of the type 2 diabetes drugs Invokana, Invokana and Invokamet XR have been updated to include a new boxed warning regarding an increased risk of leg and foot amputations, the Food and Drug Administration (FDA) announced. The approved safety label update comes two months after the FDA issued a Safety Communication alerting the public that after a review of clinical trial data, the agency has determined that its strongest warning should be added to the labels of all drugs that contain the active ingredient canagliflozin regarding the amputation risk. Invokana, Invokamet and Invokamet XR all contain canagliflozin.

The black box warning is based on new data from two large clinical trials, after which the FDA concluded that canagliflozin causes an increased risk of leg and foot amputations mostly affecting the toes and the middle of the foot. Amputations involving the leg, below and above the knee, were also seen. Some patients had more than one amputation, some involving both limbs.

The two clinical trials found that type 2 diabetics treated with canagliflozin over the course of a year had leg or foot amputations about twice as often as type 2 diabetics treated with a placebo. One study found 5.9 out of every 1,000 patients treated with canagliflozin required amputation compared to 2.8 patients treated with a placebo. The other study found 7.5 out of every 1,000 patients treated with canagliflozin required amputations compared to 4.2 out of every 1,000 patients treated with a placebo.

The approved and updated safety label information for Invokana, Invokamet, and Invokamet XR can be found by searching “canagliflozin” at drugs@FDA.

Any adverse events experienced while taking Invokana, Invokamet or Invokamet XR should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA Safety Communication