Press Release: FDA Confirms Increased Risk of Leg and Foot Amputations With Diabetes Medicine Canagliflozin
May 16 2017 - 11:23AM
Dow Jones News
FDA Drug Safety Communication: FDA confirms increased risk of
leg and foot amputations with the diabetes medicine canagliflozin
(Invokana, Invokamet, Invokamet XR)- Drug Information Update
The Division of Drug Information (DDI)- serving the public by
providing information on human drug products and drug product
regulation by FDA.
________________________________________
Based on new data from two large clinical trials, the U.S. Food
and Drug Administration (FDA) has concluded that the type 2
diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
causes an increased risk of leg and foot amputations. We are
requiring new warnings, including our most prominent Boxed Warning,
to be added to the canagliflozin drug labels to describe this
risk.
Patients taking canagliflozin should notify your health care
professionals right away if you develop new pain or tenderness,
sores or ulcers, or infections in your legs or feet. Talk to your
health care professional if you have questions or concerns. Do not
stop taking your diabetes medicine without first talking to your
health care professional.
Health care professionals should, before starting canagliflozin,
consider factors that may predispose patients to the need for
amputations. These factors include a history of prior amputation,
peripheral vascular disease, neuropathy, and diabetic foot ulcers.
Monitor patients receiving canagliflozin for the signs and symptoms
described above and discontinue canagliflozin if these
complications occur.
For more information, please visit: canagliflozin.
________________________________________
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(END) Dow Jones Newswires
May 16, 2017 12:08 ET (16:08 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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