Merck Sharp & Dohme (Asia) is recalling Tredaptive 1g/20mg Tablet (registration no. HK-57317).
Prescription drug Tredaptive recalled
January 21, 2013
The Department of Health today endorsed the decision of a licensed drug wholesaler, Merck Sharp & Dohme (Asia), to recall Tredaptive 1g/20mg Tablet (registration no.HK-49463), because new data shows the benefits of the product no longer outweigh the risks for patients.
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency 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 on January 11.
In Hong Kong, only Tredaptive is registered and is a prescription medicine used for the treatment of dyslipidaemia. The wholesaler announced a global suspension of the availability of Tredaptive on the same day.
The department has not received any adverse reaction reports related to the use of Tredaptive so far.
According to the wholesaler, about 22,300 packs (size 28) of Tredaptive were imported to Hong Kong last year. About 13,300 packs were supplied to pharmacies, doctors and hospitals.
Call 3971 2913 for enquiries. Anyone currently receiving Tredaptive should consult healthcare professionals.