ADRs that result in revision of product information or suspension of marketing authorisation
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| European Union: European Medicines Agency confirms recommendation to suspend marketing authorisations of Tredaptive, Pelzont and Trevaclyn |
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has confirmed the recommendation to suspend the marketing authorisations 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.
In the meantime, the European Commission has taken temporary measures to suspend the marketing authorisation and supply of the medicines across the European Union (EU) and the marketing authorisation holder, Merck Sharp & Dohme Ltd, has announced that it is taking steps to suspend availability of the medicines across the 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, such as bleeding (intracranial and gastro-intestinal), myopathy, infections and new onset diabetes, 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.
The CHMP opinion will be sent to the European Commission for the adoption of a legally binding decision throughout the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001694.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, Tredaptive (ER Niacin/Laropiprant) 1g/20mg Tab (HK-57317) is registered by Merck Sharp & Dohme (Asia) Ltd and is a prescription-only medicine while Pelzont and Trevaclyn are not registered pharmaceutical products. Related news has been released by the EMA, Singapore Health Sciences Authority, and the Department of Health of Hong Kong, and they were posted on Drug Office website on 22 December 2012, 9 January 2013, and 11 January 2013 respectively. A letter to inform healthcare professionals was issued on 24 December 2012. The matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, January 19 2013
Issued at HKT 12:00
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