
Doctors debate danger of popular diabetes drug after FDA amputation warning
Many San Diego doctors are taking their patients off of Invokana, a widely used diabetes drug, after a large industry-sponsored trial found it doubled the risk of lower limb amputations compared with those taking a placebo.
With 23.1 million people in the U.S. diagnosed with diabetes, many of them are taking newer drugs to control glucose. But new research involving one of those drugs, Invokana, shows a doubled rate of leg, foot and toe amputations.
Patients are being switched to other medications even though the study’s authors say the drug’s benefits — a reduced risk of cardiovascular events including death, non-fatal heart attacks and non-fatal strokes — outweigh its risk of amputations.
The drug is prescribed for people with Type 2 diabetes. The patients in the trial were already at high risk for heart disease and other diabetes complications including amputations.
While a number of physicians interviewed said they still prescribe the drug to lower their patients’ glucose levels, attitudes among others began to change after the U.S. Food and Drug Administration on May 16 issued what’s called a black box warning about amputations.
It urges patients taking canagliflozin, sold under the brand name Invokana, Invokamet and Invokamet XR, to contact their doctors “right away” if they notice pain or tenderness, sores, ulcers or infections in their legs or feet. About half of the amputations occurring among patients in the trial were of toes, while the rest were across the foot, at the ankle, below the knee and above the knee.
The FDA warning suggests physicians
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