Advice
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the marketing, supply and authorisations of extended-release niacin/laropiprant medicines (Tredaptive®) be suspended across the EU. This follows an assessment of the available data related to safety concerns, and the conclusion by the Committee that the risks are greater than the benefits in adults with dyslipidaemia.
The SMC Advice has been removed from the website.
Medicine details
- Medicine name:
- nicotinic acid/laropiprant (Tredaptive)
- SMC ID:
- 614/10
- Indication:
- dyslipidaemia
- Pharmaceutical company
- MSD
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Date advice published
- 10 May 2010