Amputation risk put the FDA’s most serious warning on a diabetes drug. That’s changed
The FDA will remove the Boxed Warning or Black Box Warning about increased leg and foot amputation risk from the packaging of type 2 diabetes drug canagliflozin.
In explaining the change, the agency cited the results of three clinical trials as well as what it gauged as a higher benefit-to-risk factor for canagliflozin compared to when it first received the warning three years ago.
The drug, sold under brand names Invokana, Invokamet and Invokamet XR since 2013, got the FDA’s most serious caution in 2017, “based on our assessment that the risk of amputations was very serious in relation to the potential benefit of canagliflozin.“
Over the next two years, the drug would be approved to treat heart and kidney problems in type 2 diabetes patients, in addition to the initial function of lowering blood sugar.
“Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored,” the FDA said. “Based upon these considerations, we have concluded that the Boxed Warning should be removed.
“The amputation risk with canagliflozin remains and is still described in the Warnings and Precautions section of the prescribing information.”
If a medical problem arises from using this or any other drug, notify your doctor or other medical professional first. Then, notify the FDA via the Adverse Event section of the website or by a form obtained with a call to 800-332-1088.
This story was originally published August 27, 2020 at 3:47 PM with the headline "Amputation risk put the FDA’s most serious warning on a diabetes drug. That’s changed."
