European Medicines Agency confirms recommendation to suspend Tredaptive (nicotinic acid/laropiprant)
Source: European Medicines Agency
Area: News
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has confirmed the recommendation to suspend the marketing authorisations of Tredaptive (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia, as its benefits no longer outweighed its risks. The results of the HPS2-THRIVE study, which are still preliminary, had indicated that taking Tredaptive together with a statin had no significant additional benefit in reducing the risk of major vascular events, compared with statin therapy alone; and it was also associated with a higher frequency of non-fatal but serious side effects.
The CHMP decision follows the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines. The marketing-authorisation holder, MSD, has, in the meantime, announced that it is taking steps to suspend availability of the medicines across the EU.
The CHMP encourages patients currently taking ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news
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