Niacin/Laropiprant Products to Be Withdrawn in EU Next Week


January 18, 2013

LONDON — The European Medicines Agency (EMA) has today confirmed its recommendation to suspend three identical niacin/laropiprant products--Tredaptive, Pelzont, and Trevaclyn--for the treatment of adults with dyslipidemia [1]. "Doctors should no longer prescribe these medicines and should review patients' treatment options," says the EMA in its statement, which notes that the medicines will no longer be available in the European Union starting next week, January 21 2013.

Niacin/laropiprant has been marketed under one of these trade names by Merck Sharp & Dohme in all EU member states except Bulgaria, France, and Romania since 2008.

The decision is no surprise; a week ago, the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA recommended that the marketing, supply, and authorizations of these three agents be suspended across the EU, and Merck said separately it would suspend the products worldwide, working with individual countries on a case-by-case basis.

Today's announcement follows a meeting this week of the EMA's Committee for Medicinal Products for Human Use (CHMP), which opted to follow last week's recommendation by the PRAC. The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.

Patients currently taking these medicines should "make a nonurgent appointment with their doctor to discuss their treatment," says the CHMP. "Pharmacists should refer patients on new or repeated prescriptions for Tredaptive, Pelzont, and Trevaclyn to the treating doctor," it adds.

The decision has been made in the wake of the HPS-2 THRIVE results, the EMA reiterates. "The results of the study, which are still preliminary, indicated that taking nicotinic acid/laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone. In addition, a higher frequency of nonfatal but serious side effects was seen in patients taking these medicines." These adverse events included bleeding (intracranial and gastrointestinal), myopathy, infections, and new-onset diabetes, it notes.

Having reviewed the results of the study, the CHMP concluded that "the benefits of Tredaptive, Pelzont, and Trevaclyn no longer outweigh the risks, and their marketing authorizations should be suspended."