Other safety alerts
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| Singapore: Recommendation not to start new patients on Tredaptive (ER niacin/laropiprant, MSD) in light of results of HPS2-THRIVE cardiovascular outcomes study |
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MSD would like to inform healthcare professionals that the HPS2-THRIVE study of Tredaptive 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 revascularisations. In addition, 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 alone. Given the current understanding of these new data and until additional analyses can be completed, physicians are advised not to start new patients on Tredaptive. It is not necessary at this time to stop Tredaptive in patients who are currently using the therapy. Healthcare professionals will be updated when new information becomes available.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
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. Related news has been released by the European Medicines Agency and was posted on the website of Drug Office on 22 December 2012. A letter to inform healthcare professionals was issued on 24 December 2012. Department of Health will keep vigilance on the above issue.
Ends/ Wednesday, January 09, 2013
Issued at HKT 12:00
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