L.,
Great point. On the back cover of Dr. Cohen's book about statins, it states:
"...Yet, many patients get side effects and a whopping 60 to 70 percent
eventually stop statin treatment."
Jason

Rita

I don't suppose any of the following information was included in the
advertisement for VYTORIN...

~~~~~~~~~~~~~~Zee

Warning from Health Canada on Zetia (aka Ezetrol, Ezetimibe) which is
one of the two drugs that make up VYTORIN. The other drug in VYTORIN is
SIMVASTATIN.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ezetrol_hpc_e.html

February 1, 2005
Subject:
Association of Ezetrol® (ezetimibe) with myalgia, rhabdomyolysis,
hepatitis, pancreatitis, and thrombocytopenia

Dear Health Care Professional,

Merck Frosst/Schering Pharmaceuticals, following discussions with
Health Canada, would like to inform you of new safety data for
Ezetrol® (ezetimibe), used alone or in combination with a statin.
Ezetimibe is a cholesterol absorption inhibitor that is classified as a
systemic drug, because of the enterohepatic recirculation of one of its
metabolites1.

The Product Monograph for Ezetrol® (ezetimibe) has been updated to
include information from international post-marketing reports of rare,
and in some cases serious, adverse events. The Patient Information
section is being updated to inform patients of the signs and symptoms
of hepatic, muscle, and pancreatic adverse events, for which early
consultation with a physician is recommended.

Additional reports of myalgia, many accompanied by elevated creatine
phosphokinase (CK) values, have been reviewed by Health Canada.

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:

   * myalgia;
   * rhabdomyolysis;
   * hepatitis;
   * acute pancreatitis;
   * thrombocytopenia; and
   * suspected interaction between Ezetrol® (ezetimibe) and warfarin

While it is not possible to definitively establish a causal
relationship between these adverse events and the use of Ezetrol®
(ezetimibe), the Product Monograph changes and the following
recommendations are based on the potentially serious nature of these
events.

Adverse muscle events:

    Myalgia

Myalgia has been reported in patients treated with Ezetrol®
(ezetimibe).

Importantly, a number of patients treated with Ezetrol® (ezetimibe) in
whom myalgia occurred, had previously experienced myalgia (with or
without elevated CK levels) with statin therapy. Patients with a
history of statin intolerance (myalgia with or without elevated CK
levels) should be closely monitored for adverse muscle events during
treatment with Ezetrol® (ezetimibe).

    Rhabdomyolysis

Patients treated with Ezetrol® (ezetimibe), who experience persistent
muscle pain, should be instructed to contact their physicians for
evaluation of the possibility of rhabdomyolysis. In most reported
cases, rhabdomyolysis resolved when the drugs were discontinued.

Adverse hepatic events:

Elevations of liver transaminases and cases of hepatitis have been
reported in patients treated with Ezetrol® (ezetimibe). Liver function
monitoring is recommended when therapy with Ezetrol® (ezetimibe) is
initiated in patients treated or about to begin treatment with a
statin.

Health care professionals should be aware that the use of Ezetrol®
(ezetimibe) in combination with a statin is contraindicated in patients
with active liver disease or unexplained persistent elevations of liver
transaminases.

Care should be exercised in the use of Ezetrol® (ezetimibe) in
patients with active liver disease or unexplained persistent elevations
of liver transaminases.

Adverse pancreatic events:

Physicians should consider the diagnosis of pancreatitis in patients
who develop sudden acute abdominal pain during therapy with Ezetrol®
(ezetimibe).

Suspected interaction between Ezetrol® (ezetimibe) and warfarin:

Additional International Normalized Ratio (INR) measurements are
recommended in patients treated with warfarin, and in whom Ezetrol®
(ezetimibe) is initiated.

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