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.


Subscribe or Register

Existing user? Login

Patient safety

Zoledronic acid 'patient card' would reduce risk of bone tissue death

The use of a patient reminder card is one of several new measures recommended by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of osteonecrosis (death of bone tissue) of the jaw associated with the bisphosphonate drug zoledronic acid (Aclasta).

The PRAC concluded that the risk of osteonecrosis of the jaw with zoledronic acid — a drug used to treat osteoporosis and other disorders of bone metabolism — was very low, but certain measures are needed to further minimise it.

The patient reminder card would inform patients about the benefits of treating osteoporosis, the risks of osteonecrosis of the jaw, the need to report any dental problems ahead of and during treatment, and the importance of maintaining good dental hygiene.

This information should also be included in the product information along with further details about how to minimise the risk of osteonecrosis of the jaw. The measures, announced on 13 March 2015, follow a routine review of the drug.

The PRAC’s recommendations will be sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the agency’s final opinion. The text of the updated Aclasta product information and the patient card will be published on the EMA’s website after the CHMP opinion expected on 26 March 2015.

The PRAC will also consider similar measures for other intravenous bisphosphonate drugs and for denosumab. These will be considered during the planned reviews for these medicines, which are scheduled to take place during 2015 and 2016.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068135

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

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.