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The Department of Health (DH) today (January 21) endorsed the total recall of Tredaptive (ER Niacin/Laropiprant) 1g/20mg Tablet (registration no. HK-57317) (Tredaptive) from the market by 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 involved in taking three branded products - Tredaptive, Pelzont and Trevaclyn - all containing niacin and laropiprant, are greater than their benefits, and recommended the suspension of their marketing authorisation," a DH spokesperson said.
"The recommendation of PRAC was based on the results from a large, long-term study called HPS2-THRIVE, which concluded that treatment with Tredaptive together with statin therapy 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."
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 PRAC recommendation.
Today, MSD decided on 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) of Tredaptive were imported into Hong Kong in 2012. About 13,300 packs were supplied to pharmacies, doctors and hospitals.
MSD has set up a hotline 3971 2913 to answer public enquiries. The DH will closely monitor the recall.
Members of the public currently receiving Tredaptive should consult healthcare professionals to review their treatment plans.
Ends/Monday, January 21, 2013
Issued at HKT 16:11
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