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December 21, 2007: Studies of Merck and Schering-Plough drug, Zetia, Never Released – Data May Show Risks to Liver

According to the New York Times today, Merck and Schering-Plough have never released data obtained in a number of studies of their cholesterol drug, Zetia. These studies may show that Zetia, when taken over long periods with statins such as Lipitor, Crestor or Zocor, can cause liver damage.

Zetia is often prescribed in concert with statins because the two drugs lower cholesterol in different ways. In some cases, patients may be prescribed Vytorin, which combines Zetia and Zocor.

The Zetia drug studies are mentioned on the U.S. Food and Drug Administration website, according to the Times. The two drug makers also have not released data from a significant study of Zetia called Enhance, although the study ended last year.

It is possible that the Enhance study showed liver damage linked with Zetia use, the Times said. Apparently, some patients who had elevated liver enzymes were dropped from the study. Merck and Schering-Plough said they will release the Enhance data by March, after experiencing pressure from lawmakers and doctors.

Over the past two years, medical journals have reported cases of serious liver damage experienced by patients taking both Zetia and statins long-term. Other countries have issued warnings about Zetia and liver damage.

The FDA approved Zetia for sale on the basis of trials conducted with 3,900 people taking the drug no longer than 12 weeks. In addition, unlike in the case of Lipitor and other statins, Zetia’s ability to reduce the risk of stroke and heart attack has not been proved. While the unpublished drug studies will not provide data on stroke and heart attack, they apparently provide insight into the risks associated with long-term use of the drug when combined with statins.

The Times also reports that Merck and Schering-Plough this year will probably earn $5 billion for the sale of Zetia.

If you or a loved one has been harmed by Zetia, and you have a question about your legal rights, please call us toll free at 1-877-934-6274, or fill out a Free Case Evaluation form. Since 1984, the Law Offices of Eric H. Weinberg have successfully represented clients that have been injured by pharmaceutical drugs, obtaining recoveries totaling more than $700 million. For more information, please visit Our Firm and Our Successful Cases on this site.

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