The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has confirmed the recommendation to suspend the marketing authorizations of Tredaptive, Pelzont, and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol). The CHMP decision follows the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines. The marketing-authorisation holder, Merck Sharp & Dohme Ltd, has, in the meantime, announced that it is taking steps to suspend availability of the medicines across the European Union (EU).
The CHMP encourages patients currently taking these medicines to make a non-urgent appointment with their doctor to discuss their treatment. Doctors should no longer prescribe Tredaptive, Pelzont or Trevaclyn and should review patients’ treatment options.
The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available. The results of the study, which are still preliminary, indicated that taking nicotinic acid / laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone. In addition, a higher frequency of non-fatal but serious side effects was seen in patients taking these medicines.
Having reviewed the results of the study, the CHMP concluded that the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks and that their marketing authorisations should be suspended.
More information on the HPS2-THRIVE study is available below.
The CHMP opinion will now be sent to the European Commission for the adoption of a legally binding decision throughout the EU.
Date: January 18, 2013
Source: European Medicines Agency