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This is duplicated text of a letter from Merck
Frosst/Schering Pharmaceuticals.
Contact the company for a copy of any references, attachments or
enclosures. |
PUBLIC ADVISORY
Health Canada Endorsed Important Safety Information on
EZETROL® (ezetimibe) |
February 1, 2005
| Subject: |
Association of Ezetrol® (ezetimibe) with
myalgia, rhabdomyolysis, hepatitis, pancreatitis, and thrombocytopenia |
Merck Frosst/Schering Pharmaceuticals, in consultation with Health Canada,
would like to inform patients of updated safety information for Ezetrol® (ezetimibe),
a medication used to help lower blood cholesterol. Ezetrol® (ezetimibe)
is sometimes used together with statins or other cholesterol-lowering medications.
The new safety information is based on reports of the following conditions
in patients taking Ezetrol® (ezetimibe), some of which may be serious:
muscle aches and pains (myalgia), muscle breakdown (rhabdomyolysis), and
inflammation of the liver (hepatitis) or the pancreas (pancreatitis). There
are also very rare reports of low blood-clotting cell counts (low platelet
count; thrombocytopenia).
It is not possible to determine if these adverse events were directly
related to the use of Ezetrol® (ezetimibe) or were due to other reasons,
such as the disease itself, other treatments, or general medical problems.
However, patients should be aware of the following updated advice for the
safe use of Ezetrol® (ezetimibe).
Muscle problems:
Muscle pains or aches account for most of the muscle problems that patients
have experienced with the use of Ezetrol® (ezetimibe).
There are reports of patients who have experienced muscle weakness, as
well as rare reports of rhabdomyolysis. Rhabdomyolysis is a condition that
results in muscle breakdown and release of muscle cell contents into the
bloodstream. In severe cases, rhabdomyolysis can lead to kidney failure
and can be life-threatening.
If you use Ezetrol® (ezetimibe) and you experience any of the following
signs or symptoms:
- persistent muscle aches or pain;
- persistent muscle weakness; or
- brown or discolored urine
you should contact your doctor immediately. In most reported cases, muscle
symptoms improved when the medications were stopped.
Liver problems
Sometimes liver function test results increase during treatment with Ezetrol® (ezetimibe).
If you use Ezetrol® (ezetimibe) with a statin, your doctor will likely
want to check your liver function tests before and after starting treatment.
If you have active liver disease, you should discuss with your doctor
whether or not Ezetrol® (ezetimibe) is right for you.
If you experience any of the following signs or symptoms of possible liver
inflammation (hepatitis):
- dark urine;
- abdominal pain (especially if felt on the right side below the ribs);
- nausea or vomiting;
- yellowing of the skin or eyes;
- general itchiness; or
- pale stools
you should contact your doctor immediately.
Pancreas problems
If you use Ezetrol® (ezetimibe) and you experience sudden acute abdominal
pain, a possible symptom of inflammation of the pancreas, you should contact
your doctor.
Changes in some laboratory blood tests
Many medications taken together with warfarin (a blood thinning drug)
may affect the clotting time of blood. If you are taking warfarin at the
same time as Ezetrol® (ezetimibe), your doctor may wish to make additional
checks of your blood clotting time.
There are very rare reports of low platelet (blood cells that help clotting)
counts in patients treated with Ezetrol® (ezetimibe).
If you experience any unusual bleeding while taking Ezetrol® (ezetimibe),
you should contact your doctor.
Merck Frosst/Schering Pharmaceuticals, in consultation with Health Canada,
is in the process of updating the prescribing information for Ezetrol® (ezetimibe).
Merck Frosst/Schering Pharmaceuticals has sent a letter to health care
professionals and pharmacists to inform them of this new safety information,
a copy of which is available on the website of the Therapeutic Products
Directorate of Health Canada, at the following address:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/index_e.html
If you have questions about your current Ezetrol® (ezetimibe) prescription,
you should contact your doctor.
For further information call our Medical Services at 1-800-567-2594, from
8:30 a.m. to 5:30 p.m. Monday to Friday, EST. For media inquiries, please
contact Sheila Murphy at (514) 428-2748.
Patients and health care providers may report suspected adverse drug reactions
to Merck Frosst/Schering Pharmaceuticals, or to Health Canada through the
Canadian Adverse Drug Reaction Monitoring Program (CADRMP) at the following
addresses:
Merck Frosst/Schering Pharmaceuticals
Attention: Director, Medical Services
P.O. Box 1005,
Pointe-Claire-Dorval,
Québec,
H9R 4P8
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll
free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel.: (613) 954-6522
Fax: (613) 952-7738
The AR Reporting Form and the AR
Guidelines can be found on the
Health Canada web site or in The Canadian Compendium
of Pharmaceuticals and Specialties. |
About Merck Frosst/Schering Pharmaceuticals
Merck Frosst/Schering Pharmaceuticals (MFSP) is a joint venture between
Merck Frosst Canada Ltd. and Schering Canada Inc., which was established
in December 2001 as part of a worldwide partnership (except Japan) between
the two companies. MFSP was formed to develop and market new prescription
medicines for the management of cholesterol.
® Registered Trademark used under license by Merck Frosst Schering
Pharma, G.P
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