Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medication safety

EMA reviews ‘restrictive’ prescribing advice for metformin

The EMA is reviewing the prescribing advice for metformin-containing medicines for treatment of type 2 diabetes because of concerns that the advice may be too restrictive. In the image, man holds up pack of metformin tablets

Source: Mark Thomas / Science Photo Library

Metformin has the potential to cause lactic acidosis, a rare but serious complication

The European Medicines Agency (EMA) is reviewing the prescribing advice for metformin-containing medicines for treatment of type 2 diabetes because of concerns that the advice may be too restrictive.

The move is in response to a request from the Dutch medicines agency following its own routine safety review of the drug. The Dutch review found that current evidence may not justify contraindicating metformin in patients with moderate reduction of kidney function.

The Dutch agency also discovered that prescribing information for metformin products varies between European Union countries and recommendations within the prescribing advice are sometimes “inconsistent” with clinical guidelines for treating diabetes.

The EMA highlights that metformin has the potential to cause the rare, but serious, complication of lactic acidosis – when lactic acid builds up in the blood faster than it can be removed. Patients who have a significant reduction in kidney function are most at risk and the current prescribing information warns against using metformin for this group of patients.

The EMA review, announced on 28 January 2016, will consider whether prescribing information for metformin and metformin combination products needs to be updated.

The National Institute for Health and Care Excellence recommends that metformin use be reviewed if the estimated glomerular filtration rate (eGFR) is below 45ml/minute/1.73m2 in adults with type 2 diabetes and that it should be stopped if the eGFR is below 30ml/minute/1.73m2. NICE also advises that the drug is prescribed with caution for those at risk of a sudden deterioration in kidney function and those at risk of eGFR falling below 45ml/minute/1.73m2

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200612

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

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

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • The EMA is reviewing the prescribing advice for metformin-containing medicines for treatment of type 2 diabetes because of concerns that the advice may be too restrictive. In the image, man holds up pack of metformin tablets
  • Metformin tablet

Jobs you might like

Newsletter Sign-up

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