Zetia can have Serious Side Effects

January 5, 2008, 11:45AM. By Heidi Turner

Seattle, WAPatients taking Zetia are now learning that the drug may come with some serious side effects. Those include liver damage, rhabdomyolysis and myopathy. What has surprised many consumers is that the makers of Zetia conducted a few studies and found that there are risks associated with taking Zetia, but did not publicize the results of those studies.

Some patients who take Zetia experience muscle pain, especially if Zetia is taken in combination with statins. Clinical studies have found that up to five percent of people taking Zetia will experience muscle pain. Some of those patients experience muscle pain as a symptom of a couple of very serious problems. Those problems are myopathy and rhabdomyolysis.

Myopathy is a disease in which muscle fibers do not function for one of a number of reasons. It is associated with muscle cramps, stiffness and spasms. Rhabdomyolysis is serious because it can cause the breakdown of muscles, which can cause acute kidney failure and can ultimately be fatal.

Patients who develop unexplained muscle pain while taking Zetia should consult with their doctor immediately. Other serious side effects include muscle tenderness or weakness, chest pain, nausea, stomach pain, and low fever.

In addition to muscle pain, Zetia has also been linked to an increased risk of liver damage when used in combination with statins. According to The New York Times, Merck and Schering-Plough, makers of Zetia, conducted several studies on Zetia that showed the drug increased the risk of liver damage. These studies are in addition to the Enhance study, also conducted by Merck and Schering-Plough, that may include information about the risks of liver damage. The article notes that some patients were dropped from the Enhance study after it was revealed that they had elevated liver enzymes—a sign of organ damage.

Patients and doctors are now concerned that they have not been given a full picture of Zetia's effects. Naturally, the companies argued that the studies were not considered scientifically important enough to have their findings published. But patients who have developed liver problems since taking Zetia would likely disagree with that statement.

Furthermore, it is interesting to note that the unpublished studies do not prove the drug's effectiveness, they simply show a broader picture of the potential risks of Zetia. According to the Times article, the unpublished studies cover a period of at least one year, enough to show some of the long-term effects of Zetia. Previously published studies only cover 12 weeks, which is not enough time to show any long-term effects.

Even more alarming is news that, according to the Times article, Zetia itself has not been proven to prevent heart attacks, which is the goal of cholesterol-lowering medications. It has only been shown to lower cholesterol levels. Other drugs, such as Lipitor, not only lower cholesterol levels they also reduce the risk of heart attacks and strokes. If patients are not reducing their risk of heart attacks and strokes, can Zetia really be worth the risks?

Merck and Schering-Plough are also under fire for changing the goals of the Enhance study to be released in March. According to The New York Times, the companies will use "only partial results to assess the trial's success in deterring the formation of plaque that can cause artery blockages and lead to heart attacks." Changing the goals of a study when the study has already begun is an unusual move and can result in the goals being changed to fit with the data found.

Zetia is used to treat high cholesterol and is often used along with statins. Patients taking Zetia often take it either with Lipitor, Crestor or Zocor (all statins) or in a single pill known as Vytorin that is actually a combination of Zetia and Zocor. Zetia works in the patient's digestive tract and blocks the absorption of cholesterol from food.