Other safety alerts
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| European Union: European Medicines Agency starts review of Tredaptive, Pelzont and Trevaclyn, since the preliminary results of a clinical study raised questions about the efficacy and safety of the medicines |
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The European Medicines Agency has started a review of the safety and efficacy of Tredaptive, Pelzont and Trevaclyn, identical medicines that are used to treat adults with dyslipidaemia, particularly combined mixed dyslipidaemia and primary hypercholesterolaemia.
The review was triggered because the Agency was informed by the pharmaceutical company Merck, Sharp & Dohme 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 the medicine when added to statins, as this 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 Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will assess the data and make a recommendation to the Committee on Medicinal Products for Human Use (CHMP), which will issue an opinion on the regulatory action required. An opinion is expected in January 2013.
While the review is ongoing, the Agency recommends that no new patients should be started on treatment with these medicines or enrolled in clinical trials involving these medicines, pending the outcome of the Agency’s assessment.
Patients currently using Tredaptive, Pelzont or Trevaclyn should not stop their treatment. Patients who have any questions should speak to their doctor at their next appointment.
This review of Tredaptive, Pelzont and Trevaclyn has been initiated by the European Commission and will be considered by the PRAC and CHMP at their January 2013 meetings.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_001686.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, Tredaptive tablet is registered by Merck Sharp & Dohme (Asia) ltd and is prescription-only medicine while Pelzont and Trevaclyn are not registered pharmaceutical products. In view of above, a letter to inform healthcare professionals will be issued. Drug Office will contact the European Medicines Agency and Merck Sharp & Dohme (Asia) Ltd to obtain further information and follow-up the situation.
Ends/Saturday, December 22, 2012
Issued at HKT 12:30
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