ADR that result in revision of patient information
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| Canada: New safety information: Risk of serotonin syndrome associated with serotonin blocking drugs used to treat nausea and vomiting |
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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 single drug.
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 ANZEMET has been withdrawn from the Canadian market by the manufacturer.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.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../39519a-eng.php
In Hong Kong, there are 12 registered pharmaceutical products containing granisetron; 21 containing ondasetron; 3 containing palonosetron; and there is no registered pharmaceutical product containing dolasetron. All of them are prescription only medicines. So far, the Department of Health has received one adverse drug reaction report related to seizure suspected to be associated with the use of Zofran (ondansetron) and has not received any relevant adverse drug reaction report in connection with granisetron and palonosetron. In view of Health Canada’s announcement, a letter to healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, May 15, 2014
Issued at HKT 16:00
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