Diabetics warned trial drugs double the risk of amputation
A drug trial that is looking at protecting diabetics against heart and kidney disease has warned participants that they could double their risk of toe, foot or leg amputation.
It is believed that dozens of people across Europe have had amputations after volunteering for Canagliflozin trials.
The UK’s medicines and Healthcare Products Regulatory Agency said that six out of the 243 participants in Britain have lost body parts.
Of the 10,000 patients who took park, those on the drug experienced double the expected number of amputations. It is still not clear if those in the UK were on the drug or the placebo.
Every year up to four in every 1000 diabetics need an amputation because of damage to the blood vessels and nerves in the legs and feet.
The interim results from the independent committee monitoring the trail shows that the rate rises to eight in every 1,000 among those on the drug.
Dr Rozlyn Bekker, medical director at Janssen, the drug maker, wrote to doctors last year warning of the risk, which varied with dosage. “Serious adverse event monitoring has observed an approximately two-fold higher incidence of lower limb amputation (primarily of the toe),” she said.
Janssen, the company behind the drugs, is part of Johnson & Johnson. They said it was unable to provide figures about the trial.
It was the European Medicines Agency that confirmed the doubling of amputations of people on the drug.
They allowed the trail to continue because of the benefits to high-risk patients. The trial was due to end last month.
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