ADR that result in revision of patient information
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| Suspension of Availability of Tredaptive (Niacin/Laropiprant) Extended Release 1g/20mg (HK-57317)
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European Union:
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee considers that benefit-risk balance of Tredaptive, Pelzont and Trevaclyn is negative |
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The Department of Health (DH) today (January 11) was informed by Merck Sharp & Dohme (Asia) Ltd that the company is taking steps to suspend the availability of Tredaptive worldwide.
These steps to suspend the availability of Tredaptive are based on the current understanding of the data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, and following further consultation with certain regulatory authorities concerning those data. The HPS2-THRIVE study did not meet its primary endpoint of reduction of major vascular events which included the combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations. Also in this study, there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received Tredaptive and statin compared to the group that received statin without Tredaptive.
The company plans to recommend that physicians should stop prescribing Tredaptive. Patients who are currently receiving Tredaptive should be reviewed in a timely manner (e.g, in the next few months) to amend their treatments in order to discontinue Tredaptive and to consider other changes in therapy to achieve dyslipidemia management goals. Patients should not discontinue lipid therapy prior to consultation with their physicians.
Meanwhile, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the risks are greater than the benefits for Tredaptive, Pelzont and Trevaclyn, identical medicines used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol), and it recommended that these medicines should be suspended.
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 at the next CHMP meeting of 14-17 January 2013.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000014.jsp&mid=WC0b01ac05805c516f
In Hong Kong, Tredaptive 1g/20mg Tab (HK-57317) is a prescription-only medicine while Pelzont and Trevaclyn are not registered pharmaceutical products. Related news had been released by the European Medicines Agency and Singapore Health Sciences Authority, and they were posted on Drug Office website on 22 December 2012 and 9 January 2013 respectively. A letter to inform healthcare professionals was issued on 24 December 2012. DH will keep vigilance on the development and the above matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Drug Office
Department of Health
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