Vytorin lawsuits filed over drug’s effectiveness

A class action lawsuit has been filed in New York against drug manufacturers Merck & Co., Inc. and Schering-Plough Corporation over their cholesterol-reducing drug Vytorin.

The suit alleges that the companies withheld significant findings from patients and doctors about the medication’s effectiveness in reducing the fatty plaques that can lead to a heart attack or stroke. Among other things, the suit seeks the return of money to consumers who purchased Vytorin.

Other lawsuits raising similar allegations have been filed, including a proposed class-action in Seattle.

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.”

Vytorin combines Zocor, a statin that inhibits the body’s own production of cholesterol in the liver, with Zetia, a drug that blocks its absorption in the intestines.

A four-year study, called the Enhance trial, found that while Vytorin lowered cholesterol from both food and liver production, it performed no better than a generic, less-expensive form of Zocor in preventing arterial plaque build-up.

The Enhance study concluded in 2006, but the results were not released by Schering-Plough and Merck & Co. until January 2008. That prompted an investigation by Congress as to whether the drug makers improperly delayed publicizing the results.

In addition to the questions raised by the Enhance findings, patients who take Vytorin are subject to a range of side effects, including: muscle pain, tenderness, weakness, flu-like symptoms, unexplained fatigue and blurred vision.