EMA starts risk-benefit review of nicotinic acid and related substances

Source: European Medicines Agency Area: News The European Medicines Agency (EMA) has started a review of nicotinic acid and its related substances acipimox and xantinol nicotinate used to treat lipid disorders.   The review follows new data from a study which found the combination of nicotinic acid and laropiprant did not reduce the risk of major vascular events, and was in fact associated with a higher frequency of non-fatal but serious side effects. As a result, the EMA recommended the suspension of medicines containing the combination of nicotinic acid and laropiprant across the EU.   As data from the study may have implications for medicines containing only nicotinic acid or related substances, the EMA will now assess the impact of the new data on the benefit-risk balance of these medicines, and will issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news