Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medicines
Safety Notices
My HPRA:
Login
Register
About Us
Medicines
COVID-19 vaccines and treatments
Our Role
Medicines Information
Safety Information
Safety Notices
Quality Information
Regulatory Information
News & Events
Special Topics
Emergency Medicines
Emergency Contact Details
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
European Medicines Agency (EMA) announces a review of Tredaptive, Pelzont and Trevaclyn
Notice type:
3rd Party Publications
Date:
21/12/2012
Product name or type:
Tredaptive, Pelzont,Trevaclyn
Problem Or Issue:
The EMA has commenced a review of the safety and efficacy of Tredaptive, Pelzont and Trevaclyn, medicines which are used to treat adults with dyslipidaemia (abnormally high levels of fat in the blood), particularly 'combined mixed dyslipidaemia' and 'primary hypercholesterolaemia'. The review was triggered after the Agency was informed by the pharmaceutical company Merck, Sharp and Dohme of the preliminary results of a large, long-term study comparing the clinical effects of adding these medicines to statins (standard medicines used to reduce cholesterol) with statin treatment alone. The study raises questions about the efficacy of the medicine when added to statins, as this did not reduce the risk of major vascular events (serious problems with the heart and blood vessels, including heart attack and stroke) compared with statin therapy alone.
Background Information Or Related Documents:
European Medicines Agency (EMA) announces a review of Tredaptive, Pelzont and Trevaclyn Document
Actions To Be Taken:
Pending the outcome of this review (expected in January 2013), the EMA recommends that no new patients should be started on treatment with these medicines. Patients currently using Tredaptive, Pelzont or Trevaclyn should not stop their treatment. Patients who have any questions should speak to their doctor at their next appointment.
Healthcare professionals in the European Union (EU) will receive a letter in the next few days outlining the updated information on the use of these medicines.
Further Information:
For full EMA statement please refer to link below.
European Medicines Agency - press release
Tredaptive (nicotinic acid/laropiprant) - Letter to Healthcare Professionals
Irish Medicines Board communication on PRAC recommendation on Tredaptive
« Back
Date Printed: 04/05/2024