Archive for December, 2008

Healthfacts - Vytorin and Zetia continue to be prescribed despite hints of harms and no proof of benefit

Wednesday, December 31st, 2008

There is no proof that Zetia can do anything beyond lowering cholesterol–no evidence that it can reduce heart attacks or cardiovascular disease, which, of course, is the ultimate goal. Once again, this…

USA TODAY - Vytorin doesn't prevent deadly hardening of heart valve

Thursday, December 25th, 2008

The blockbuster cholesterol-lowering drug Vytorin failed to slow age-related hardening of the heart valve that without surgery can lead to heart attack, stroke or death, doctors said Monday.

Vytorin worked no better than a placebo at blocking aortic stenosis, which leads to 95,000 valve-replacement operat…

Chain Drug Review - Congressional committee wants to see Vytorin analysis

Sunday, December 21st, 2008

WASHINGTON — The House Energy and Commerce Committee wants the Food and Drug Administration to turn over the results of an analysis about the potential links between cancer and the cholesterol drug Vytorin, which is sold jointly by Merck & Co. and Schering-Plough Corp.
A recent study indicated that Vytorin not only failed to help people with heart value disease avoid further problems but also appeared to increase their risk of cancer.
The study, known …

Internal Medicine News - Major CV events not decreased with Vytorin

Friday, December 19th, 2008

Combined simvastatin plus ezetimibe treatment not only failed to reduce major cardiovascular events, but also was linked to an increase in cancer deaths among asymptomatic patients with aortic stenosis, according to the first report of a randomized, placebo-controlled, phase III trial.
The only positive outcome of the 1,873-patient SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study was in the secondary end point of reduced ischemic events. Rel…

FDA Setting the Bar to Low? Cause for Medical Malpractice in New York

Wednesday, December 17th, 2008

One of the FDAs responsibilities is to regulate and control prescription drugs available on the market. However recently questions have risen as to whether the FDA is setting the proper controls on how drugs get approval. The FDA in the past has had numerous drugs that have had to be recalled because they were causing negative side effects for people taking the d…

M2 Presswire - FDA announces labeling changes on heart benefit associated with cholesterol drug zocor.

Thursday, December 11th, 2008

A firestorm of bad publicity erupted over cholesterol drugs last month when an expensive combination drug proved to be no better than an older drug alone. This finding was suppressed for 20 months by Merck and…

M2 Presswire - FDA Issues Early Communication about an Ongoing Review of Vytorin.

Friday, December 5th, 2008

On the eve of a date with congressional investigators, executives from Merck and Schering-Plough acknowledged Monday that their blockbuster cholesterol drug, Vytorin, offered no benefit over Zocor.

The news that Vytorin fell short of an old stand-by statin drug, now sold as a cheap ge…

News: Merck Shares Slide over 7% with Regulatory Stall of …

Tuesday, December 2nd, 2008

Merck & Co. received a second blow to its cholesterol-management program sending its stock down $7.72%. FDA issued a not approvable letter for MK-0524A, while earlier this year data was published showing that another Merck cholesterol product, Vytorin, was no more effective than a cheaper generic drug.
Merck opened the day at $38.24. The companys shares have been trading below $42 ever since news o…