Patients who take the cholesterol lowering drug Zetia in combination with other drugs known as statins should be aware of the potential for liver damage.

According to news reports, unpublished research has raised questions about that serious side effect when Zetia is used with a statin over a long period of time.

In the last two years, medical journals have reported scattered instances of severe liver damage in patients taking Zetia and statins. Both Australia and Canada have warned consumers about Zetia’s potential to cause hepatitis, pancreatitis and depression.

That’s not the only negative news for Zetia. In January, the drug’s manufacturers reported that a clinical trial of Zetia failed to show that the drug lowered the risk of heart attacks or strokes. That is one of the primary goals of a cholesterol-lowering medication.

Zetia was approved by the FDA in 2002. The agency considered data from several two-week trials involving 3,900 patients. That data revealed that 11 times as many people who took Zetia with a statin, compared to those who took a statin alone, developed serious health problems, most of them liver-related. The FDA approved the drug without requiring a longer trial period.

Zetia, which typically lowers cholesterol by 15 to 20 percent, has been prescribed to millions of patients who often take the drug with statins such as Lipitor and Crestor. In 2007, the product generated $5 billion in sales for two drug makers, Merck & Co., Inc., and Schering-Plough Corporation.

About six of every 10 patients take Zetia through a pill named Vytorin, which combines two drugs: Zocor, a statin which inhibits cholesterol production in the liver; and Zetia, which blocks cholesterol absorption in the intestines.

Vytorin was approved in 2004 by the FDA and heavily marketed under a campaign that touted the drug’s ability to treat the two sources of bad cholesterol: “food and family.”

Concerns about Vytorin’s effectiveness came to light in January 2008, when Schering-Plough and Merck finally released data from a 2006 study called the Enhance trial.

According to the findings of the Enhance trial, combining Zetia with Zocor produced no better results than a cheaper statin alone in reducing the risk of arterial plaque build up or heart attack and stroke. This meant that patients who were taking Vytorin for this specific purpose were paying for a medication that did not give them that benefit.

On January 2008, Merck and Schering-Plough found themselves facing several class action lawsuits related to Zetia and Vytorin. The suits allege that the companies withheld significant findings from patients and doctors about the medications’ effectiveness.

At Oshman & Mirisola our experienced attorneys will provide you with aggressive representation in the handling of your case. If you or a loved one suffered a serious injury that may have been caused by the use of Zetia, please contact us today for a free no-obligation consultation.

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