OTTAWA, May 14, 2014 /CNW/ - Health Canada has completed a safety review
of the serotonin blocking drugs dolasetron (ANZEMET), granisetron
(KYTRIL and generics), ondansetron (ZOFRAN and generics) and
palonosetron (ALOXI), which are used for treating nausea and vomiting.
This review identified a potential risk of serotonin syndrome.
Serotonin syndrome occurs when serotonin, a chemical normally found in
the body, accumulates to high levels. This usually happens with
combinations of certain serotonin drugs, but may also occur with a
It is very important to diagnose serotonin syndrome early as it can be
fatal if not treated. Symptoms of serotonin syndrome may include
agitation, confusion, fast heartbeat, muscle twitching or stiffness,
fever, loss of consciousness or coma. As serotonin syndrome can be
misdiagnosed, it is important that patients who experience any of these
symptoms should talk to a healthcare practitioner immediately.
The Canadian Product Monographs for ALOXI, KYTRIL and ZOFRAN now contain
this new safety information. ANZEMET has been withdrawn from the
Canadian market by the manufacturer. Manufacturers of generic versions
of these drugs will also update their Product Monographs.
Health Canada has received two domestic reports of serotonin syndrome
involving this class of drugs. The reported cases did not result in
fatalities. Cases of serotonin syndrome or other serious or unexpected
adverse reactions in patients receiving these drugs should be reported
to the manufacturers, or to Health Canada.
Serotonin Blockers Summary Safety Review
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SOURCE: Health Canada
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