Merck and Schering-Plough Pharmaceutical companies have not disclosed long term medical studies concerning the risk of liver injury from the cholesteral drug Zetia according to a New York Times article published yesterday. Could this be yet another incidence of a drug company concealing information about the danger of a drug to increase sales? We may not know until March 2008 when these studies will be released.
Zetia is used with statin drugs such as Zocor and Lipitor. It is also included in Vytorin in the same pill with Zocor. Zetia is often used along with statin drugs because it is promoted to reduce cholesteral in a different way than statins. There is no medical study that establishes that Zetia actually results in lower heart attack or stroke rates than use of statins alone.
Most of the studies on Zetia that have been published are only 12 weeks long. There apparently are 5 long term studies that were not published. The Zetia label in the U.S. contains only minimal warnings about the drug’s risk of liver damage. The warnings on the product required in Australia and Canada cautions about risks of hepatitis, pancreatitis, and depression.
In the clinical studies submitted to the FDA for the 2002 approval of the drug 11 times as many people who took Zetia along with a statin had serious health problems, mostly liver related, than those that took a statin alone.
I hope this is not another example of the marketing of a pharmaceutical product where company profit is given a priority over public safety.