Concern has been raised about a possible link between the cholesterol-reducing drugs Zetia and Vytorin and possible liver damage.

Two studies by the drugs’ manufacturers – Merck and Schering-Plough, respectively – indicated the potential risk but those studies were never published, according to a Dec. 21, 2007 report in The New York Times.

Questions concerning liver damage arose over the use of Zetia when taken long term along with other drugs called statins, including name brands Lipitor, Crestor and Zocor. Vytorin is a combination of Zetia and Zocor.

The Times (see article) noted that a third and ongoing study, dubbed the Enhance study, dropped participants after a number of patients suffered liver problems. It also cited reports from the Netherlands in which two patients developed hepatitis, a liver disease, after they took Zetia with Lipitor. One of the patients died.

If you or someone you love took Zetia or Vytorin and suffered severe liver damage or liver-related problems, you may want to contact a Zetia attorney or a Vytorin attorney.

In addition to potential liver problems, a study released in January 2008 showed that Vytorin, the combination of Zetia and Zocor, had no significant benefit in slowing atherosclerosis (plaque buildup in the carotid artery) when compared to using Zocor alone. Television ads were suspended a week after the study revealed Vytorin to be no more effective than generic equivalents of Zocor available at one-third the price. TV ads for Zetia were also pulled.

There were also immediate complaints from doctors and members of Congress that the negative results of the Enhance study had been delayed -- the last patient was out of the study in April 2006 -- with some congressional leaders calling for an investigation.

Zetia was approved for use in the United States in 2002 by the U.S. Food and Drug Administration, but even then one FDA reviewer cautioned that Zetia should not be taken with statins because the combination had produced liver damage in animals. (Most people take Zetia with a statin because the two drugs work in different ways to lower cholesterol.)

The FDA approval also was based on trials that covered patients who took Zetia for only 12 weeks. In comparison, the two unpublished studies cited by The Times included several thousand patients who took Zetia with statins for one to two years.

Also, the trials reviewed by the FDA in granting approval did show signals that Zetia taken with statins might be problematic. Serious health problems, most of them liver-related, were noted with 11 times the frequency in patients who took Zetia with statins.

Zetia’s label currently contains only mild warnings about potential liver damage. Officials in other jurisdictions, such as Canada, have issued more severe warnings about possible hepatitis, pancreatitis and depression.

Sales of Zetia were expected to reach $5 billion for 2007.

Kline & Specter, PC, is a Philadelphia-based law firm with some 30 attorneys, several of whom are also doctors. The firm is a leader in pharmaceutical litigation in Pennsylvania, New Jersey and nationwide. Contact a Zetia lawyer or Vytorin lawyer today.


  • New evidence shows that the drug makers Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results.(Full story)*