PRAC recommends suspension of marketing authorisations of extended-release niacin/laropiprant (Tredaptive®) across the EU
Source: European Medicines Agency
Area: News
The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the marketing, supply and authorisations of extended-release niacin/laropiprant medicines (Tredaptive®) be suspended across the EU. This follows an assessment of the available data related to safety concerns, and the conclusion by the Committee that the risks are greater than the benefits in adults with dyslipidaemia. For further details, please see a related Q&A document at the link below.
The EMA recently advised that no new patients be started on tr...
Source: NeLM - Cardiovascular Medicine - January 14, 2013 Category: Cardiology Source Type: news
Merck To Stop Producing Dyslipidemia Drug Tredaptive
Merck has just announced plans to stop producing the extended-release niacin/laropiprant drug TREDAPTIVE. The drug, used to manage dyslipidemia, is not approved in the U.S. and the company is about to suspend the worldwide availability of it completely. These measures come following the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, the results of which indicate that the drug is not nearly as effective as previously thought. The drug was found to be associated with a number of serious adverse events... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - January 12, 2013 Category: Consumer Health News Tags: Cholesterol Source Type: news
Tredaptive Cholesterol Drug Axed Over Serious Side Effect Fears
Doctors are being told that cholesterol drug Tredaptive does not work and can trigger serious and sometimes life-threatening side effects. They have been told to stop prescribing the medication. Merck has announced plans to stop producing the extended-release niacin/laropiprant drug Tredaptive . The drug, used to manage dyslipidemia (high levels of cholesterol and fat in the blood), is not approved in the U.S. and the company is about to suspend the worldwide availability of it completely... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - January 12, 2013 Category: Consumer Health News Tags: Cholesterol Source Type: news
What Merck Told Doctors About Tredaptive Before It Stopped Selling It
This morning, Merck announced that it would suspend sales of Tredaptive, the heart drug that combines the B vitamin niacin with a new medicine, laropiprant, that prevents niacin's main side effect, hot, unpleasant, facial flushing. This comes just weeks after a big trial of Tredaptive not only found that the drug did not prevent heart attacks, strokes, and heart procedures as was expected bu that it also caused many serious side effects. The European Medicines Agency also issued a review saying that Tredaptive's benefits do not outweigh its risks. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 11, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
Merck Pulls Niacin Drug
(MedPage Today) -- Merck is suspending worldwide availability of its niacin drug Tredaptive, after the European Medicines Agency recommended it no longer be marketed in Europe. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - January 11, 2013 Category: Cardiology Source Type: news
Niacin/Laropiprant Products to Be Suspended WorldwideNiacin/Laropiprant Products to Be Suspended Worldwide
The European's Medicines Agency is likely the first of many to propose the suspension of niacin/laropiprant products for dyslipidemia following the failure of the HPS-2 THRIVE trial; Merck confirms it will suspend availability of the medicine where it is available. News Alerts (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - January 11, 2013 Category: Cardiology Tags: Cardiology News Alert Source Type: news
Niacin/laropiprant products to be suspended worldwide
The European's Medicines Agency is likely the first of many to propose the suspension of niacin/laropiprant products for dyslipidemia following the failure of the HPS-2 THRIVE trial; Merck confirms it will suspend availability of the medicine where it is available. (Source: theHeart.org)
Source: theHeart.org - January 11, 2013 Category: Cardiology Source Type: news
Merck Starts To Suspend Worldwide Availability Of Tredaptive
In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 11, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
Merck Provides Update on Next Steps for TREDAPTIVE™ (extended-release niacin/laropiprant)
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
today announced the company is taking steps to suspend the availability
of TREDAPTIVE™ (extended-release niacin/laropiprant) tablets
worldwide. TREDAPTIVE is not approved for use in the United States.
Language:
English
Contact HTML:
MerckM...
Source: Merck.com - Research and Development News - January 11, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Source Type: news
Merck Provides Update on Next Steps for Tredaptive (extended-release niacin/laropiprant)
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 11, 2013 - Merck
(NYSE: MRK), known as MSD outside of the United States and Canada,
today announced the company is taking steps to suspend the
availability of TREDAPTIVE™... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 11, 2013 Category: Pharmaceuticals Source Type: news
Will Merck's Failure With Tredaptive Impact How Drugs Are Approved in Europe?
Just before the holiday season, Merck announced that it was halting a major clinical trial with its cardiovascular (CV) disease drug, Tredaptive. Tredaptive is a drug which combines extended-release niacin with laropiprant. Niacin (also known as Vitamin B3) is a drug that has been used for decades to help patients control dyslipidemia. Basically, niacin is one of the few compounds known to raise HDL, the so-called good cholesterol, albeit modestly. It has been prescribed to patients at risk for heart disease with abnormally low HDL. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 2, 2013 Category: Pharmaceuticals Authors: John LaMattina Source Type: news
