New Safety Information For Ezetimibe
Feb 5, 2005 - 7:29:00 PM
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By Akanksha, Pharmacology Correspondent,
[RxPG] Merck Frosst/Schering Pharmaceuticals,in consultation with Health Canada,today informed patients of updated safety information for Ezetrol(R)(ezetimibe),a medication used to help lower blood cholesterol.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 ezetimibe,some of which may be serious: myalgia,rhabdomyolysis,hepatitis and pancreatitis.There are also very rare reports of thrombocytopenia.
It is not possible to determine if these adverse events were directly related to the use of 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 updated advice for the safe use of ezetimibe.
Muscle pains or aches account for most of the muscle problems that patients have experienced with the use of 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.In most reported cases,muscle symptoms improved when the medications were stopped.
Any patient on ezetimibe with complaints of persistent muscle aches or pain;persistent muscle weakness;or,brown or discolored urine,should report to their doctor immediately.
Sometimes liver function test results increase during treatment with ezetimibe.Any patient on ezetimibe along with a statin,should get their liver functions checked before and after starting treatment.In a patient with active liver disease,ezetimibe should be reconsidered.
Any patient on ezetimibe with signs or symptoms of possible
hepatitis, viz : 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,should contact their doctor immediately.
A patient on ezetimibe experiencing sudden acute abdominal pain,a possible symptom of pancreatitis,should contact their doctor immediately.
Clotting time should be checked for those patients on warfarin and ezetimibe,simultaneously.
There are very rare reports of thrombocytopenia in patients treated with ezetimibe.However any patient experiencing any unusual bleeding while on ezetimibe,should contact their doctor.
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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.
Publication:
Merck Frosst/Schering Pharmaceuticals
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Additional information about the news article
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Merck Frosst/Schering Pharmaceuticals, in consultation with Health Canada, is in the process of updating the rescribing information for Ezetrol(R)(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.
If you have questions about your current 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 [email protected]
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