21 January 2013
The Department of Health (DH) today (January 21) endorsed the total recall of Tredaptive (ER Niacin/Laropiprant) 1g/20mg Tablet (Registration number: HK-57317) (Tredaptive) from the market by a licensed drug wholesaler, Merck Sharp & Dohme (Asia) Ltd. (MSD) because new data showed that the benefits of the product no longer outweigh the risks for patients.
'On January 11, 2013, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) considered the risks of three branded products Tredaptive, Pelzont and Trevaclyn, all containing niacin and laropiprant, are greater than their benefits and recommended the suspension of their marketing authorization,' a DH spokesperson said.
'The recommendation of PRAC was based on the results from a large, long-term study called HPS2-THRIVE, concluded that treatment with Tredaptive together with a statin failed to show significant benefit on the reduction of major vascular events such as heart attack and stroke compared with statin therapy alone. In addition, there was an increased frequency of serious, but non-fatal, side effects in patients taking the medicine, such as bleeding, muscle weakness, infections and new-onset diabetes,' the spokesperson continued.
In Hong Kong, only Tredaptive is registered and is a prescription medicine used for the treatment of dyslipidaemia (i.e. abnormally high blood levels of fats such as triglycerides and cholesterol). MSD announced a global suspension of the availability of Tredaptive on the same day.
On January 18, 2013, the Committee for Medicinal Products for Human Use of the EMA confirmed the recommendation of PRAC.
Today, MSD decided a total recall of Tredaptive from the market.
So far, the DH has not received any adverse drug reaction reports related to the use of Tredaptive.
According to MSD, about 22,300 packs (size 28