Following a safety and efficacy review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the marketing, supply and authorisations for the dyslipidaemia drugs Tredaptive, Pelzont and Trevaclyn–all drugs that contain laropiprant and nicotinic acid—be suspended across the European Union
The PRAC made the decision after assessing available data related to safety concerns over Tredaptive, Pelzont and Trevaclyn, which are identical medicines that are used to treat adults with dyslipidaemia. This is the first recommendation by the PRAC on a referral procedure since the pharmacovigilance legislation became operational in July 2012.
The recommendation is the result of a safety and efficacy review of the drugs that the EMA started in December 2012. According to an EMA press statement, the review was triggered because the agency was informed by the pharmaceutical company Merck, Sharp & Dohme (who markets all three drugs) of the preliminary results of a large, long-term study comparing the clinical effects of adding these medicines to statins with statin treatment alone. The study raises questions about the efficacy of these medicines when added to statins, as they did not reduce the risk of major vascular events compared with statin therapy alone. In addition, in the preliminary results, a higher frequency of non-fatal but serious side effects was seen in patients taking the medicines than in patients only taking statins.
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. The final opinion is expected to be adopted at the CHMP meeting of 14 to 17 January 2013.