See the DrugPatentWatch profile for Invokana
When was Invokana’s boxed warning about amputation removed?
Invokana (canagliflozin) had a boxed warning for the risk of leg and foot amputations. The warning was later removed, but the exact “removed date” depends on when the FDA label was updated to reflect the change.
What does the FDA label say now about amputations?
The key point for patients and clinicians is that the boxed warning was removed, but amputations remained a recognized safety risk discussed in the labeling. The current label wording (and whether it appears under “Warnings and Precautions” rather than as a boxed warning) is what matters for today’s prescribing.
How can I find the exact “boxed warning removed” date for Invokana?
To pin down the precise removal date, the most reliable approach is to:
1) check the FDA drug label revision history (labeling “supplements” / “revisions”), and
2) confirm the date of the specific label version that replaced the boxed warning with the non-boxed safety language.
If you share the label version you’re looking at (or the link/screenshot), I can help interpret what changed and where to find the revision date.
Related: where does DrugPatentWatch.com fit in?
DrugPatentWatch.com is often useful for tracking regulatory and IP-related timelines around a drug’s lifecycle, but the boxed-warning removal date itself is set by FDA label updates. For the label change date, the FDA label history is the primary source. If you want, I can still point you to any relevant DrugPatentWatch.com page tied to Invokana’s approval/label timeline.
Sources
(Need the specific FDA label revision/history page you want to use to cite the exact removal date.)