Type 2 diabetes drug linked to amputation risk
A link has been found between a type 2 diabetes drug and a higher risk of amputation, research has shown.
Scientists discovered a link between the usage of NICE-recommended canagliflozin to treat the condition and an increase in lower-limb amputations.
As a result of the findings, GPs may now consider stopping the use of the drug in people with diabetes with foot problems, the European Medicines Agency (EMA) has said.
The EMA announced it will review the drug – which can be found in Invokana – after results from the CANVAS study discovered there was a greater chance of toe amputations for patients.
Speaking to Pulse Today, the EMA Said: “As a precautionary measure, doctors may consider stopping treatment with canagliflozin in patients who develop significant foot complications.”
Despite the EMA saying the link between the two is currently unconfirmed, it has requested more information from the manufacturers to assess whether any changes need to be made with how the medicine is used.
Canagliflozin is used for treating people with type 2 diabetes as part of a dual or triple therapy process, sometimes used alongside insulin.
Scientists originally were looking at whether the drug can help to reduce cardiovascular disease, but instead observed an increase in amputations amongst participants taking canagliflozin compared to a placebo.
Importance of routine foot care
Letters have been sent out to re-iterate to doctors the importance of routine foot care in people with diabetes, as they are at a higher risk of infection and ulceration which can require amputations.
Janssen, makers of Invokana, have made it clear that patients should not just stop taking the drug as a result of the study findings.
A spokesperson for Janssen told Pulse Today: “Janssen has conducted rigorous and thorough analyses of the available data and the higher incidence of this finding seen in the ongoing CANVAS study has not been observed across 12 other completed phase 3 and phase 4 clinical trials or in post-marketing safety monitoring reports.
“Canagliflozin provides an important treatment option for people with type 2 diabetes. Patients prescribed canagliflozin should not discontinue it without discussion with their treating physician.”
People who are seeking medical advice should speak to their doctor or pharmacist, but are urged to continue with their prescribed treatment.