Zetia Liver Damage
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Zetia Liver Damage
Zetia is a heart medication designed to improve cholesterol counts that was put on the market in 2002 by drug companies Merck and Schering-Plough. The clinical tests performed in order to gain FDA approval showed that Zetia both lowered LDL counts (“bad cholesterol”) and might raise HDL counts (“good cholesterol”). The final phase of those clinical trials was performed over a twelve week period, which was sufficient to gain initial FDA approval.
Zetia has proven to be a big seller for the drug companies, usually prescribed in conjunction with one of the “statin” drugs that have been available in generic form for some time; the two most widely prescribed are Zocor and Lipitor. Following Zetia’s introduction to the market, testing continued to determine longer term effects of the drug.
That study was completed in April of 2006, but Merck and Schering-Plough declined to release it, citing the need to examine the data thoroughly. After repeated requests from the FDA and an inquiry from Congress, the study remained private until the New York Times learned of it and ran a story in December of 2007. The study showed that Zetia had no real impact on the development of plaque in the arteries – the principal cause of heart attacks and strokes. Moreover, there was some indication of heightened liver problems among patients who had been using Zetia for a prolonged period in conjunction with a statin drug.
In fact, one of the FDA researchers during clinical trials in 2002 – prior to the drug’s introduction – recommended against its approval because of increased liver damage in test animals when combined with a statin. Those initial tests also showed that patients taking Zetia in combination with a statin were eleven times more likely to have health problems – almost all of which were liver related – than patients taking just a statin drug. The FDA felt that potential benefits from the drug outweighed the risks.
The long withheld test data was finally released in mid-January and confirmed that Zetia had no impact on the frequency of cardiovascular incidents. The test was not designed to highlight the frequency of side effects, but the question of heightened liver damage remains to be answered. The two drug companies have launched a test with thousands, rather than hundreds of participants in order to provide more thorough data.
People who are at risk for heart disease and take statin drugs are tested frequently for liver enzyme levels. It is entirely possible that the addition of Zetia to a patient’s pharmaceutical intake may contribute as well to the possibility of liver damage. What is certain is that Zetia has been a huge financial success for the drug companies, providing seventy percent of Schering-Plough’s revenues in recent reports.
