Merck & Co says it is recalling Tredaptive tablets, approved in the EU for treating patients with high cholesterol
Merck & Co has said it is recalling Tredaptive cholesterol tablets in response to trial results that raised safety concerns and the recommendations of a European Medicines Agency safety panel.
Tredaptive tablets are approved in the EU and elsewhere – but not in the US – for treating patients with high cholesterol levels. They contain niacin (vitamin B3), which increases levels of ‘good’ HDL cholesterol, and laropiprant, a patent protected compound designed to reduce facial flushing, a common side effect of taking niacin.
The data suggest that the tablets are not as effective as hoped at reducing heart attacks, deaths and strokes in patients with high levels of ‘bad’, LDL cholesterol. They also suggest that the side effects are worse than expected.
Merck & Co said that doctors should stop prescribing the drug and review treatment plans for patients already taking it.
US regulators rejected laropiprant for market approval in 2008.