EMA Pharmacovigilance committee calls for Tredaptive suspension; contraceptives update

At meetings held last week, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) assessed available data related to safety concerns over Merck & Co’s (NYSE: MRK) cholesterol drug Tredaptive, Pelzont and Trevaclyn - identical medicines containing the active ingredients nicotinic acid and laropiprant - and recommended that the marketing, supply and authorizations of these medicines be suspended across the European Union.

Following the announcement, Merck said it is withdrawing Tredaptive from global markets, and said it is recommended that physicians stop prescribing the drug and review treatment plans for patients taking it. The drug is not yet approved in the USA, where the company dropped plans to gain Food and Drug Administration approval (The Pharma Letter December 21).

This is the first recommendation by the PRAC on a referral procedure since the pharmacovigilance legislation became operational in July 2012. The prompt decision-making by the PRAC to recommend the suspension of Tredaptive, Pelzont and Trevaclyn underlines that the new pharmacovigilance legislation provides an efficient mechanism for member states to swiftly address safety concerns, the EMA noted.