PRAC recommends suspension of marketing authorisations of extended-release niacin/laropiprant (Tredaptive®) across the EU

Source: European Medicines Agency Area: News 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. For further details, please see a related Q&A document at the link below.   The EMA recently advised that no new patients be started on treatment with Tredaptive® or enrolled in clinical trials evaluating it, pending the outcome of the review (see NeLM report at the link below).    The PRAC recommendation will be considered by the Agency's Committee for Medicinal Products for Human Use (CHMP), which will adopt a final scientific opinion at its meeting of 14-17 January 2013. The final CHMP opinion, together with full advice for ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news