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Diabetics warned of significantly increased risk of amputation associated with Canagliflozin

New clinical trial data published has indicated that patients taking a popular diabetes drug may be at a significantly increased risk of lower-limb amputation.

Left leg amputee

19 June 2017

Canagliflozin, marketed under the name Invokana or Vokanamet, is used to treat type 2 diabetes. It is part of a class of drugs known as SGLT2 inhibitors.

The two long-term clinical trials, CANVAS and CANVAS-R, were studying patients taking Canagliflozin who were deemed to be high cardiovascular risk. The results were published in the New England Journal of Medicine and showed that the drug reduces cardiovascular events by 14%, but also was associated with a significant doubling of risk of lower limb amputation, primarily of the toe or metatarsal.
 
The Sunday Times reported earlier this year that the Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that 6 of the 243 Britons involved in the trials had lost body parts.
 
Dr Rozlyn Bekker, medical director at the drug maker Janssen, part of Johnson & Johnson, wrote to clinicians last year saying: “Serious adverse event monitoring has observed an approximately two-fold higher incidence of lower limb amputation (primarily of the toe)…” 
 
Bekker added that “the absolute risk” was higher in patients with previous amputations.
 
Brian McFerran, a product safety lawyer at Leigh Day, commented:
 
“What is particularly concerning about these results is that this drug has been on the market since November 2013 and many patients may be unaware of this significant risk. Furthermore, experts have been unable to determine why the drug has caused an increased incidence of amputations.
 
“I would encourage the Europeans Medicines Agency to look very carefully at whether the benefits of taking this drug continue to outweigh the risks for patients.”
 
The European regulator has advised patients to check their feet regularly and follow their doctor’s advice on routine preventative foot care and adequate hydration. Any patients who have concerns or questions should speak to their doctor as soon as possible. 
 
SGLT2 inhibitors work by blocking a protein in the kidneys which absorbs glucose back from the urine into the bloodstream. By blocking the action of this protein, the medicine causes more glucose to be lost in the urine, thereby reducing the levels of glucose in the blood.
 
The consumer law and product safety team at Leigh Day specialise in bringing claims against drug companies. 

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