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

Use of strontium ranelate should be suspended because of heart risk

Strontium ranelate (Protelos) should no longer be used to treat osteoporosis, according to new recommendations from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).

In April 2013, the PRAC advised restricting the use of strontium ranelate to patients with severe osteoporosis who have a high risk of fracture. It also recommended that the medicine should not be used by patients with uncontrolled hypertension or current or past history of ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, because new data revealed an associated risk of heart problems. This restriction was backed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) later that month.

The latest review found that for every 1,000 patient-years there were four more cases of serious heart problems (including heart attacks) and four more cases of blood clots or blockage of blood vessels with strontium ranelate compared with placebo.

In addition, strontium ranelate is associated with other risks, including serious skin reactions, disturbances in consciousness, seizures, liver inflammation and a reduced number of blood cells.

The PRAC concluded that the balance of benefits and risks for strontium ranelate is no longer favourable and recommended that its use should be suspended until new data show a favourable balance in a defined patient group.

These latest recommendations will now be sent to the CHMP, which is expected to issue the agency’s final decision at its next meeting later this month (January 2014).

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11132692

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

  • Patient Care in Community Practice

    Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00Buy now
  • Clinical Pharmacokinetics

    Clinical Pharmacokinetics

    A practical guide to the use of pharmacokinetic principles in clinical practice. Includes case studies with questions and answers.

    £33.00Buy now
  • Strategic Medicines Management

    Strategic Medicines Management

    A practical guide to influencing the availability of medicines, and policies of their use. Focuses on the strategic elements of medicines management.

    £33.00Buy now
  • Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics covers all aspects of drug use in renal failure. Shows the role of the pharmacist in patient care for chronic kidney disease.

    £38.00Buy now
  • Drugs and the Liver

    Drugs and the Liver

    Drugs and the Liver assists practitioners in making pragmatic choices for their patients. It enables you to assess liver function and covers the principles of drug use in liver disease.

    £38.00Buy now

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

  • Man clutching chest (Lisa F Young/Dreamstime.com)

Newsletter Sign-up

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