EU body recommends suspending Tredaptive
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed recommending suspension of the marketing authorizations of Merck’s Tredaptive, Pelzont and Trevaclyn (nicotinic acid/laropiprant) used to treat adults with dyslipidemia. The CHMP decision follows the recent recommendation by the Pharmacovigilance Risk Assessment Committee to suspend these medicines.
In the meantime, the European Commission has taken temporary measures to suspend the marketing authorization and supply of the medicines across the European Union (EU) and the marketing authorization holder, Merck Sharp & Dohme, has announced that it is taking steps to suspend availability of the medicines across the EU.
CHMP is encouraging 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 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, CHMP concluded that the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks and that their marketing authorizations should be suspended.
The CHMP opinion will now be sent to the European Commission for the adoption of a legally binding decision throughout the EU.