Mass Torts Update - Written by Jere Beasley on Tuesday, October 7, 2008 8:42 - 0 Comments

FDA investigates possible Vytorin-cancer link

vytorin 280x210U.S. regulators are investigating whether the cholesterol-lowering Vytorin might be linked to . The U.S. informed health-care professionals that the agency was investigating a report from the so-called Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of and an increased risk of a variety of cancers. is a combination made up of the compounds simvastatin and ezetimibe that’s designed to reduce levels of LDL (bad) cholesterol and cut the risk of cardiovascular problems. It works by decreasing the production of cholesterol by the liver and inhibiting the absorption of cholesterol in the intestine.


The has obtained preliminary results from the SEAS trial. The trial tested whether lowering LDL-cholesterol with would reduce the risk of cardiovascular problems in people with narrowing of the aorta, the body’s largest artery. The five-year trial did not show a reduced cardiovascular risk. But, according to the , a “larger percentage of patients treated with were diagnosed with and died from all types of combined, when compared to treatment with a placebo.” The says patients can continue to take the . But the agency urged health-care professionals to monitor their patients for possible side effects and report them to the agency. While one recent clinical trial indicated higher rates of for patients taking the , the said two studies currently under way have shown no increased risk, according to an Associated Press report.

The said it expects to receive a final study from the SEAS trial in about three months. It will then take an estimated six months to review and evaluate the trial data. is made by the companies Merck and Schering-Plough Pharmaceuticals. It’s a combination of Merck’s Zocor (simvastatin), a statin, and Schering-Plough’s Zetia. A report earlier this year found the failed to reduce the buildup of plague in arteries any better than the generic Zocor. Several members of Congress have demanded data on the trial. I understand that Merck and Schering-Plough are cooperating with the requests. But the companies defended the , saying it is effective at reducing cholesterol — the use for which it was approved – but that doesn’t address the risk issue.

Source: HealthDay




Leave a Reply

Comment

Comments are moderated and generally will be posted if they are on-topic and not abusive.

Powered by WP Hashcash

Recent Settlements - Jul 1, 2009 7:20 - 0 Comments

Serious eye injury case settled in Pike County

More In Recent Settlements


Product Liability - Jul 1, 2009 7:19 - 0 Comments

The single vehicle accident: a series highlighting often overlooked product claims

More In Product Liability


Recalls Update - Jul 1, 2009 7:50 - 0 Comments

Starbucks recalls 530,000 coffee grinders

More In Recalls Update