MHRA Drug Safety Update: TredaptiveT (niacin-laropiprant) no longer recommended for prescribing

Source: MHRA Area: News The January issue of the MHRA's Drug Safety Update has featured new data from a long-term study (HPS2-THRIVE) involving over 25 000 patients which indicated that adding TredaptiveT (fixed dose niacin-laropiprant) to simvastatin did not provide significant additional benefit in reducing the risk of major vascular events compared with statin therapy alone. In addition, a higher frequency of bleeding (intracranial and gastro-intestinal), myopathy, infections and new-onset diabetes was seen in patients taking Tredaptive with simvastatin, compared with patients taking simvastatin alone.   In light of the latest evidence, the benefit-risk balance for Tredaptive is considered negative, and the medicine has been recalled. A letter informing healthcare professionals of this decision was circulated in January 2013.
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news