Previous Posts
- This blog has moved
- Avandia Given Positive Reviews Due to $$$$$?
- The FDA and Drug Approval
- J&J Planned Profit from Risky, Unapproved Uses of ...
- What Are the Different Classes of Drug Recalls?
- What Is the Difference Between Class Action and Mu...
- First Lawsuit for Avandia Filed In Santa Clara Cou...
- Our Involvement in the Yaz®/Yasmin® Litigation
- What Is An FDA Black Box Warning?
- What Is a Drug Recall?
Archives
- April 2008
- May 2008
- May 2009
- June 2009
- July 2009
- August 2009
- September 2009
- October 2009
- November 2009
- December 2009
- January 2010
- February 2010
- March 2010
- April 2010
Click Here to View
Our Other Site
Tuesday, December 22, 2009
FDA Investigates Vytorin
Vytorin is a combination of simvastatin (Zocor) and ezetimibe (Zetia). Vytorin reduces the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.
In August 2008, the U.S. Food and Drug Administration (FDA) issued an Early Communication describing a possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. The Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. FDA has now completed its review of the data from the SEAS trial as well as a review of recent data from two large-scale ongoing cardiovascular trials with Vytorin. Based on the currently available information, FDA believes it is unlikely that Vytorin increases the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out.
FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol lowering medications. Consumers should talk to their healthcare professional if they have any questions about Vytorin, Zetia, Zocor or the SEAS trial.
For more information about the FDA’s report, click here.
In August 2008, the U.S. Food and Drug Administration (FDA) issued an Early Communication describing a possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. The Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. FDA has now completed its review of the data from the SEAS trial as well as a review of recent data from two large-scale ongoing cardiovascular trials with Vytorin. Based on the currently available information, FDA believes it is unlikely that Vytorin increases the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out.
FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol lowering medications. Consumers should talk to their healthcare professional if they have any questions about Vytorin, Zetia, Zocor or the SEAS trial.
For more information about the FDA’s report, click here.
Labels: cancer, FDA, health care providers, Vytorin
posted by
Megan M. McBride
at
3:15 PM
Thursday, July 16, 2009
Drug Makers Agree to Pay $5.4 Million for a Cholesterol Drug Cover-Up
Drug makers, Merck & Co. and Schering-Plough Corporation, agreed yesterday to pay $5.4 million to settle civil claims that the companies covered up test results that cast doubt on the effectiveness of their two blockbuster cholesterol drugs, Vytorin and Zetia.
In 2006 a series of studies were done by the two companies that revealed Vytorin and Zetia were less effective in reducing plaque build-up. However, the companies failed to release their findings immediately, which consequently resulted in criticism from several attorney generals.
The companies settled with attorney generals from 35 states, including the District of Columbia and Wisconsin. Merck Co. and Schering- Plough both agreed to pay back the costs of the investigation, but they do not have to make other payments or admit liability.
In 2006 a series of studies were done by the two companies that revealed Vytorin and Zetia were less effective in reducing plaque build-up. However, the companies failed to release their findings immediately, which consequently resulted in criticism from several attorney generals.
The companies settled with attorney generals from 35 states, including the District of Columbia and Wisconsin. Merck Co. and Schering- Plough both agreed to pay back the costs of the investigation, but they do not have to make other payments or admit liability.
Labels: cholesterol, Merck Co, million dollar, settlment, Vytorin, Zetia
posted by
Chavon Williams
at
8:29 AM