US drug giant Merck & Co yesterday said that it is recalling its good HDL cholesterol-raising drug Tredaptive, in overseas markets after it failed to prevent heart problems in a study, raising safety concerns.
The New Jersey-based company said that it is taking these steps based on the preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, and in consultation with regulatory authorities.
HPS2-THRIVE did not achieve its goal of reduction of major vascular events, and there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received the drug compared to statin therapy.
It added that the decision to recall the drug is also aligned with the recommendation of the European Medicine Agency's Pharmacovigilance Risk Assessment Committee based on the trial's results.
Tredaptive is not approved in the US but the drug has been approved in approximately 70 countries, including in Europe, and is sold in approximately 40 countries.
Merck said that it is encouraging doctors to stop prescribing Tredaptive and is also recommending that physicians review treatment plans for patients taking the drug to discontinue it and consider other therapies.