2005 Dear Doctor Letter Issued In Canada for Cholesterol Drug Ezetrol/Zetia
No Corresponding Letter Sent To US Doctors As Of 2007
On February 1, 2005 Health Canada posted a Dear Doctor letter warning about Zetia (ezetimibe) -- Called Ezetrol in Canada -- on its site from Merck Frosst / Schering Pharmaceuticals. The letter was intended to draw attention to some serious side effects associated with Zetia, including:
The Warnings, Precautions, and Adverse Events sections are being updated to reflect the occurrence of the following adverse events in patients taking EzetrolŪ (ezetimibe) alone or in combination with a statin:
- acute pancreatitis;
- thrombocytopenia; and
- suspected interaction between EzetrolŪ (ezetimibe) and warfarin
Additionally, the Canadian Dear Doctor letter warned of the possibility of liver injuries associated with the use of 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.
Subsequent to the 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.
In the U.S., however, the drug companies responsible for Zetia, Merck and Schering-Plough, chose not to send any corresponding Dear Doctor letter to American health care professionals, nor did the FDA mandate that they do so. The risks associated with Zetia have only recently been brought to public attention in a New York Times article about unpublished Zetia studies.
Read more about Zetia on our Zetia and Vytorin Information Page >>