Existing user? Login

Adverse drug events

EMA to review canagliflozin over amputation risks

The European Medicines Agency (EMA) has announced that it is reviewing the diabetes drug canagliflozin after an ongoing clinical trial found it may increase the rate of lower limb amputations.

The incidence of amputation in the Canagliflozin Cardiovascular Assessment Study (CANVAS) is currently 7 in 1,000 patient-years among participants treated with canagliflozin 100mg daily and 5 in 1,000 among those receiving the 300mg daily dose. This compares with a rate of 3 in 1,000 patient-years in the placebo group. The incidence of lower limb amputation is primarily related to toe amputation.

The study has enrolled around 4,300 patients who have so far been followed up for an average of 4.5 years.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has asked for additional information from the drug’s manufacturer to allow it to assess the drug’s association with amputations. It will also look at data on other sodium glucose co-transporter 2 inhibitors.

The EMA says that none of the 12 previous clinical trials involving canagliflozin identified a link with amputations. Another ongoing trial called CANVAS-R, in which patients have so far been followed up for an average of nine months, has shown a non-significant increase in the rate of amputations compared with placebo.

Both trials are designed to assess the effect of canagliflozin on cardiovascular disease and involve patients at high-risk of cardiovascular events. The trials’ independent data monitoring committee has recommended that the trials continue.

Following the review by the PRAC, the Committee for Medicinal Products for Human Use will adopt an opinion on the use of the drug in the EU.

Citation: Electronicjuice DOI: 10.1211/PJ.2016.20201036

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Health Policy and Ethics

    A comprehensive review of health policy, ethics, economics, and health care delivery around the world.

  • Integrated Pharmacy Case Studies

    Over 90 case studies based on real life patient-care scenarios. Each case includes learning outcomes and references.

  • Non-prescription Medicines

    Reviews over-the-counter medicines, arranged by the conditions they are licensed to treat. Includes product recommendations.

  • Application and Review of Pediatric Pharmacotherapy

    Increase your understanding of pharmacotherapy prescribed to pediatric patients with these realistic case studies.

  • Suppositories

    A detailed review of suppository dosage forms. For all those involved in the formulation, development, manufacture and testing of suppositories.


Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.