Source: Brachytherapy  |  Posted 7 years ago

MONTREAL, QC -- February 8, 2005 -- - 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/hpfb-dgpsa/tpd- dpt/index_advisories_professionals_e.html.

If you have questions about your current Ezetrol (ezetimibe) prescription, you should contact your doctor.

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,
Quebec, H9R 4P8

or

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.ca

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.

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

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.

For further information: For media inquiries, please contact Sheila Murphy at (514) 428-2748

SOURCE: Merck Frosst/Schering Pharmaceuticals