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The type 2 diabetes prescription drug canagliflozin appears
to increase the risk of leg and foot amputations, the U.S.
Food and Drug Administration says. The FDA is requiring the
medications to carry new warnings about the risk. The
required warnings on the drug's labeling include the most
serious and prominent boxed warning. The agency's decision
is based on data from two large clinical trials showing that
leg and foot amputations occurred about twice as often in
patients taking canagliflozin as among those taking a
placebo. Amputations of the toe and middle of the foot were
the most common, but leg amputations below and above the
knee also occurred. Some patients had more than one
amputation; some had amputations involving both limbs,
according to the FDA. Left untreated, high blood sugar
levels can cause a number of possible complications,
including heart disease, kidney problems and amputations,
according to the American Diabetes Association.
Canagliflozin is meant to be used with diet and exercise to
lower blood sugar in adults with type 2 diabetes. It belongs
to a class of drugs called sodium-glucose cotransporter-2
(SGLT2) inhibitors. These drugs lower blood sugar levels by
causing the kidneys to remove sugar from the body through
the urine. Patients taking canagliflozin should immediately
notify their health care providers if they develop new pain
or tenderness, sores or ulcers, or infections in the legs or
feet, the FDA said in a news release. Patients should not
stop taking their medication without first talking to their
health care provider. Before prescribing canagliflozin to
patients, doctors should consider factors that may
predispose patients to the need for amputations, including a
history of prior amputation, peripheral vascular disease,
neuropathy, and diabetic foot ulcers, the FDA said. In
addition, doctors should monitor patients taking
canagliflozin for the above signs and symptoms, and
discontinue canagliflozin if these complications occur. |