From rxpgnews.com
New Safety Information For Ezetimibe
By Akanksha, Pharmacology Correspondent
Feb 5, 2005, 19:29
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.
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