Ezetrol Drug Toxicity

Cholesterol Drug Zetia May Cause Serious Liver Injury Including ...

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Back on February 1, 2005 Health Canada posted on its web site a so-called "Dear Doctor" letter about Zetia (ezetimibe) -- called Ezetrol in Canada -- from Merck Frosst / Schering Pharmaceuticals that was intended to draw attention to some serious side effects associated with Zetia.  That 2005 Dear Doctor letter included the following:

The Warnings, Precautions, and Adverse Events sections are being updated to reflect the occurrence of the following adverse events in patients taking Ezetrol® (ezetimibe) alone or in combination with a statin:

In the U.S., however, Merck and Schering-Plough -- the drug companies responsible for Zetia, here -- chose not to send any corresponding Dear Doctor letter to American health care professionals, nor did the FDA mandate that they do so.

Returning to this 2005 Dear Doctor letter about Zetia , here is what was said about liver injuries to patients using Zetia and a statin drug (such as Zocor, Lipitor, Crestor, Lescol, Mevacor, or Pravachol):

Adverse hepatic events:

Elevations of liver transaminases and cases of hepatitis have been reported in patients treated with [Zetia]. Liver function monitoring is recommended when therapy with [Zetia] is initiated in patients treated or about to begin treatment with a statin.

Health care professionals should be aware that the use of [Zetia] in combination with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations of liver transaminases.

In the two years since this 2005 Dear Doctor letter about Zetia was sent by the Merck and Schering group in Canada there have been some case reports of serious liver injury in patients using Zetia and statins -- but for the most part Zetia-induced liver injury had been off-the-radar for most drug safety observers. 

Now we have some idea about why, perhaps, Zetia-induced liver injury side effects were not more widely known.

In a December 21, 2007 article, "Data About Zetia Risks Was Not Fully Revealed" , New York Times ) reporter Alex Berenson broke the story that Merck and Schering-Plough had conducted several studies of Zetia which, in fact, raised the possibility that Zetia can cause liver damage when used long-term with other statins -- but these drug companies decided not to publish the results of those Zetia studies.