Class 2 Drug Alert (Action Within 48 Hours): Merck Sharp & Dohme Ltd - Tredaptive modified-release tablets - Nicotinic acid and Laropiprant - EL (13)A/02

Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Stock from MSD (Merck Sharp & Dohme Ltd) and Parallel Distributors   Tredaptive modified-release tablets   EU/1/08/459/002 and EU/1/08/459/003   (Nicotinic acid and Laropiprant)   All unexpired stock of both originator and parallel-distributed packs of this product are being recalled to Pharmacy, clinic and wholesaler level irrespective of batch number, expiry date and pack size.   The product is being withdrawn throughout the EU after a study has shown a failure to reduce major vascular events and an increase in non-fatal serious adverse events. Both CHMP and the Pharmacovigilance Risk Assessment Committee have concluded that the benefits no longer outweigh the risks.   Our information from the European Medicines Agency indicates that one parallel-distributor, Swingward Ltd T/A Medihealth has registered as a parallel-distributor. Both originator and paralleldistributed stock is in the ...
Source: NeLM - Drug Alerts - Category: Drugs & Pharmacology Source Type: alerts